Discogenic lumbosacral radiculopathy: clinical guidelines

List of Abbreviations

LBP – low back pain

VAS – visual analogue scale (for pain)

HIV – human immunodeficiency virus

GC – glucocorticoids

LSR – lumbosacral radiculopathy

GIT - gastrointestinal tract

IL – interleukins

ICD-10 – International Classification of Diseases, 10th Revision

MRI – magnetic resonance imaging

NSAIDs – non-steroidal anti-inflammatory and antirheumatic drugs

PET – positron emission tomography

CT – computed tomography

SN – spinal nerve

US – ultrasound examination

LCE – level of confidence of evidence

GRS – grade of recommendation strength

TNF – tumor necrosis factor

NRS – numerical rating scale (for pain)

ENMG – electroneuromyography

EMG – electromyography

Terms and Definitions

Discogenic lumbosacral radiculopathy (DSR) is damage to the lumbar or first sacral spinal nerve (SN) roots due to their compression by intervertebral disc components, manifested by pain and/or sensory disturbances in the corresponding dermatomes, weakness in the corresponding myotomes (indicator muscles), and reduction or loss of the knee or Achilles reflexes. DSR lasting up to 4 weeks is considered acute, from 5 to 12 weeks – subacute, and after 12 weeks – chronic.

In addition to disc herniation, there are other causes of nerve root compression in radiculopathy, such as ligamentum flavum hypertrophy, osteophyte formation, facet joint hypertrophy, foraminal stenosis, and spondylolisthesis. Root damage can be associated with neoplasms – root neurinomas, primary and metastatic vertebral tumors, meningeal carcinomatosis; congenital anomalies – arteriovenous malformations, arachnoid and synovial cysts; infections – osteomyelitis, epidural abscess, tuberculosis, herpes zoster, Lyme disease, HIV infection; inflammatory diseases – sarcoidosis, vasculitis; endocrine and metabolic disorders – diabetes mellitus, Paget's disease, acromegaly. However, these causes, excluding degenerative-dystrophic changes of the spine, collectively account for less than 1% of radiculopathy cases and are not covered in these guidelines.

Lumbosacral pain (sciatica) is a pain syndrome in the lumbar region radiating to the leg. This term primarily refers to non-specific musculoskeletal pain syndromes, i.e., conditions where the sources of pain may be muscles, joints, and ligaments, but not the spinal nerve roots.

Intervertebral disc protrusion is displacement of disc fragments involving less than 25% of the circumference, with the length of the displaced fragment being less than the width of its base.

Intervertebral disc extrusion is displacement of disc fragments where the size of the displaced fragment in any plane exceeds the size of the base. Sequestration is a subtype of extrusion in which the displaced disc fragment loses continuity with the base.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Discogenic lumbosacral radiculopathy (DSR) is damage to the lumbar or first sacral spinal nerve (SN) roots due to their compression by intervertebral disc components (protrusion, extrusion), manifested by pain and/or sensory disturbances in the corresponding dermatomes, weakness in the corresponding myotomes (indicator muscles), and reduction or loss of the knee or Achilles reflexes [1-9].

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

DSR is caused by intervertebral disc protrusion or extrusion (herniation). Disc herniation development is driven by a combination of age-related progressive degenerative changes in spinal structures, connective tissue characteristics, and physical stressors (e.g., heavy physical labor, non-physiological working postures, prolonged static loads, sudden uncoordinated movements) [6-8,10-14]. Heavy physical labor, obesity, and smoking play an important role in the onset of the first episode of radiculopathy [15]. Intervertebral disc herniations on magnetic resonance imaging (MRI) or computed tomography (CT) are conveniently described according to the classification [10], which distinguishes disc protrusion (bilateral size of the herniated fragment's base is larger than the bilateral size at the apex), disc extrusion (rupture of the annulus fibrosus, bilateral size of the herniated fragment's base is smaller than any of the herniated fragment's dimensions), and sequestration (the herniated fragment is located separately from the disc).

Intervertebral disc herniations are common in elderly, middle-aged, and even young individuals. Intervertebral disc herniations may be asymptomatic (without back pain or other symptoms); therefore, their detection on spine MRI or CT in a patient with back pain does not mean they are the cause of it [1,3,4,7,8].

In the pathogenesis of DSR, besides compression-ischemia-induced SN damage, local inflammatory and autoimmune reactions play an important role. Annulus fibrosus rupture brings the nucleus pulposus into contact with the immune system, which perceives it as a foreign body, triggering autoimmune reactions with B-lymphocyte activation and autoantibody production, as well as cytotoxic T-lymphocytes. This in turn causes a complex cascade of immunological reactions with the release of large amounts of cytokines (IL-1α, IL-1β, IL-6, IL-8, prostaglandin E2, and TNF-α) that sustain inflammation and contribute to pain [6,16]. The immunological mechanism also underlies the natural reduction of disc herniation over time; resorption of herniated fragments occurs over several months via biochemical degradation of connective tissue components and phagocytosis [6,16]. The regression of inflammatory changes outpaces the reduction in disc herniation size, and pain and other neurological deficits resolve before the disc herniation is seen to regress [17]. Pain in DSR is mixed in nature—being both nociceptive and neuropathic [18].

1.3 Epidemiology of the Disease or Condition

According to various sources, the prevalence of DSR ranges from 1.6% to 13.4%, peaking at 45–64 years of age, and is more common in men than in women. Among patients with back pain presenting to general practitioners, this diagnosis is established in 2–11% of cases [19,20].

The prevalence of disc herniations is high in the general population, including asymptomatic cases; therefore, a comprehensive clinical and neuroimaging assessment of the patient's condition is essential [9].

1.4 Features of Coding the Disease or Condition

M51.1 – Lumbar and other intervertebral disc disorders with radiculopathy

G55.1* – Nerve root and plexus compressions in disorders of intervertebral discs (* not to be used as a primary code)

1.5 Classification of the disease or condition

DSR is classified as acute (up to 4 weeks), subacute (from 4 to 12 weeks), and chronic (after 12 weeks) [9,21,22].

1.6 Clinical presentation of the disease or condition

DSR is characterized by acute shooting pain in the lower back and leg, often triggered by significant physical exertion, such as lifting heavy objects. It frequently worsens with coughing, sneezing, and forward bending, and eases in the recumbent position [1,3,4,7,8,18,23]. The fifth lumbar and first sacral roots are most commonly affected (up to 90% of cases), followed less frequently by the fourth lumbar root, and very rarely by the upper lumbar roots [1,3,4,7]. Lesions of the 5th lumbar or 1st sacral root typically radiate below the knee into the foot and toes, while 4th root lesions radiate along the anterior and lateral thigh [8,24].

Main clinical manifestations of DSR: 1) lower back pain radiating to the leg; 2) sensory disturbances in the corresponding dermatomes; 3) weakness in the corresponding myotomes (indicator muscles); 4) diminished or absent knee or Achilles reflexes; 5) positive nerve root tension signs [1,3,4,7,8,18,23,24]. Clinical manifestations of root lesions at various levels are presented in Appendix G1. Typically, neuropathic pain syndrome predominates, characterized by intense acute shooting or, less commonly, burning pain, paresthesias, and other sensory impairments radiating to the distal dermatome.

The clinical course of DSR is favorable; approximately half of patients improve within 4–12 weeks, and the majority (55–70%) of patients experience a gradual resolution of symptoms within a year [25–27]. Spontaneous partial regression of a sequestered disc herniation is observed in 96% of cases, extrusion in 70%, disc protrusion in 41%, and complete regression of a sequestered herniation in nearly half (43%) of observations [17]. Repeat MRI studies over the course of a year show more than a twofold reduction in size for approximately 60–70% of intervertebral disc herniations [28].

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis. Diagnostics of lumbar disc radiculopathy (LDR) is indicated for all patients with suspected LDR. The diagnosis of LDR is established based on the collection of complaints and anamnesis of the disease; a brief somatic examination to rule out "specific causes"; a neurological examination (extent of pain and hypesthesia, reflex changes, presence of muscle atrophy, limb paresis; the results of neurodynamic tests are of great importance). Neuroimaging results are not independently significant in diagnostics and must be correlated with the clinical picture of the disease. Clinical diagnostic methods for LDR are detailed in Appendices G1-G4.

2.1 Complaints and Anamnesis

When collecting complaints and anamnesis in patients with suspected LDR, it is recommended to use a brief questionnaire to identify signs of so-called "specific" causes of the disease in order to choose further management tactics for the patient (Table 1) (Level of Evidence – 5, Grade of Recommendation – C) [29-32].

Table 1. Red flags for back pain.

If a patient with suspected LDR presents with red flags, an additional examination of the patient (somatic and neurological examination, neuroimaging) is recommended (Level of Evidence – 5, Grade of Recommendation – C) [6-8,19,23,33] to search for specific causes of the disease.

To assess the severity of the condition and treatment efficacy in patients with LDR, it is recommended to evaluate pain intensity both at the time of presentation and dynamically (Level of Evidence – 3, Grade of Recommendation – B). Standardized scales can be used for this: visual analogue scale (VAS), numerical rating scale (NRS), verbal rating scale (VRS) [34,35] (Appendix G2).

2.2 Physical Examination

A somatic examination of patients with suspected LDR is recommended to rule out specific causes of back pain; it aims to detect signs of spinal fractures, malignant neoplasms, infectious processes, and other somatic conditions that may present with back pain, and includes checking for fever, weight loss, skin changes, lung auscultation, abdominal and lymph node palpation (Level of Evidence – 5, Grade of Recommendation – C) [3,8,9,21,22,26,33]. If signs of a specific disease are detected, additional examinations are recommended (Table 2).

Table 2. Some red flags, their possible causes, and recommended medical tactics in patients with back pain

Clinical examination with neurological status assessment is the basis of LDR diagnostics (Appendices G3, G4). For clinical evaluation, a comprehensive examination is recommended, including analysis of pain localization and character, detection of paresis and sensory disorders, evaluation of knee or Achilles reflexes, testing for tension signs (sitting or supine straight leg raise test, straight and crossed Lasègue signs), as well as exclusion of specific causes of pain (Level of Evidence – 5, Grade of Recommendation – C) [3,7,8,21-23,33].

Establishing the diagnosis of LDR is recommended based on a triad: 1) Based on complaints, anamnesis, and examination (Tables 1, 2), no red flags regarding specific causes of back pain were identified; 2) Clinical examination with neurological status assessment revealed signs of LDR, positive tension tests; 3) Neuroimaging results (if available) directly correlate with the clinical picture (disc herniation localization corresponds to pain radiation zones and sensory disorder distribution, weakness in "indicator" muscles, loss of corresponding reflexes (Appendix G1). (Level of Evidence – 5, Grade of Recommendation – C) [3,7,8,23,33,36].

To assess the severity of impaired functions, disease dynamics, and the effectiveness of ongoing treatment in LDR, the use of the Oswestry or Roland-Morris questionnaires is recommended (Appendices G5 and G6) (Level of Evidence – 3, Grade of Recommendation – B) [37].

Comments. In some cases, manifestations similar to LDR are observed in foraminal (lateral lumbar) stenosis caused by a cyst or other causes of lumbar spinal nerve compression, or in piriformis syndrome with sciatic nerve compression [8,24,36]. Piriformis syndrome is determined based on its palpation, regression of pain and other symptoms after local anesthetic administration into the muscle; foraminal stenosis is determined based on clinical data and MRI [8,24,36].

2.3 Laboratory Diagnostics

In LDR, there are no changes associated with this condition in the complete blood count, general general-health biochemical blood test, urinalysis, as well as in other laboratory tests.

Laboratory tests are not recommended in LDR unless there are signs of a specific cause of non-specific low back pain (spinal fracture, infectious, systemic inflammatory, oncological, or other disease) [10-11] (Level of Evidence – 5, Grade of Recommendation – C).

2.4 Instrumental Diagnostics

Patients with manifestations of LDR are recommended to undergo magnetic resonance imaging of the spine (one segment) in the presence of red flags (Level of Evidence – 5, Grade of Recommendation – C), as MRI makes it possible to rule out specific causes of pain (tumor, fracture, etc.) and other neurological diseases [1,3,7,21-23,36].

If MRI is contraindicated, computed tomography of the spine (one segment) or CT myelography (computed tomography of the spine with intravenous contrast (one segment)) is recommended to rule out a specific disease (Level of Evidence – 5, Grade of Recommendation – C) [1,3,7,21-23,36].

Emergency MRI or CT of the spine (one segment), CT of the spine with intravenous contrast (one segment) is recommended upon detection of cauda equina syndrome (pelvic organ dysfunction, loss of perineal sensation, progressive paresis of both legs) to determine further treatment tactics (Level of Evidence – 5, Grade of Recommendation – C) [1,3,7,21-23,36]. In the absence of red flags and a typical clinical picture, performing MRI, CT (one segment), or radiography of the lumbosacral spine within the first 4 weeks is not recommended (Level of Evidence – 2, Grade of Recommendation – A), because there is no evidence of the necessity for early (up to 4 weeks) spine imaging [8,9]. MRI, CT, and radiography do not improve disease outcomes in patients with LDR [38-40].

If there is no improvement in condition (regression of pain and other neurological disorders) within 4–6 weeks, MRI or CT of the lumbosacral spine (one region) is recommended to rule out a specific cause of the disease and to refer the patient for a neurosurgical consultation if a clinically significant disc herniation is detected (Level of Evidence – 5, Grade of Recommendation - C) [40-42].

MRI or CT of the spine (one region) is recommended at an early stage (within 4 weeks) if: 1) the patient has progressive neurological deficits or persists with severe pain despite therapy, in order to rule out a specific disease; 2) epidural administration of GCs and local anesthetics is planned, in order to determine the size and localization of the disc herniation and the level of intervention (Level of Evidence – 5, Grade of Recommendation - C) [40-42].

Comments. Since MRI does not involve ionizing radiation and is informative in detecting disc herniations, its use is preferred over CT and CT myelography. When ordering CT and CT myelography, the radiation dose should be taken into account.

2.5 Other Procedures

Instrumental diagnostic methods (needle electromyography (ENMG) of one nerve, stimulation electroneuromyography of one nerve, needle electromyography (EMG) of one muscle, surface electromyography of one anatomical zone, registration of somatosensory evoked potentials of motor nerves (SSEP)) are recommended only in patients with an unclear clinical picture of lumbosacral radiculopathy, to rule out spinal cord lesions and other diseases of the peripheral nervous system (Level of Evidence – 5, Grade of Recommendation - C) [1,6,7].

Comments. ENMG investigates the conduction velocity of excitation along motor and sensory fibers of peripheral nerves, the amplitudes of motor and sensory responses, and their latencies. If ENMG reveals signs indicative of peripheral nerve pathology, additional electrodiagnostic studies, such as EMG, should be considered. Needle EMG of the muscles of affected myotomes may reveal spontaneous activity (signs of denervation) and reinnervation changes in motor unit action potentials. The somatosensory evoked potential method in this case can be useful for ruling out a spinal level of sensory impairment.

In chronic lumbosacral radiculopathy, assessment of psychological and social pain factors is recommended (Level of Evidence – 5, Grade of Recommendation - C), because their presence helps refine the prognosis of the disease and enables the use of effective psychological therapy methods [3,43,44].

Comments. In clinical practice, psychological and social aspects are evaluated relatively rarely. The assessment of psychological and social factors is carried out primarily in specialized pain treatment centers.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

Introduction to the section. In each case of acute lumbosacral radiculopathy, it is necessary to determine which treatment strategy to prefer: surgical or conservative methods. Emergency surgical treatment is recommended only in the presence of absolute indications (see the surgical treatment section). In all other cases, the dynamics of changes should be assessed over a period of 6 to 12 weeks of the disease, and only then should the issue of the advisability of surgical intervention be decided. Conservative treatment of lumbosacral radiculopathy involves a comprehensive approach including pharmacotherapy, non-pharmacological methods of intervention, and in some cases (mainly in the acute and subacute periods) epidural GC injections (see other treatment methods section). Physiotherapy, manual therapy, reflexology for diseases of the peripheral nervous system, massage, and other non-pharmacological methods do not have major independent significance in the treatment of lumbosacral radiculopathy, but are components of a comprehensive treatment program.

3.1 Conservative Treatment

3.1.1 Non-pharmacological treatment

In cases where patients are forced to observe bed rest due to intense pain, its duration should not exceed 3–5 days. Longer bed rest worsens the course of the disease [47]. It is advisable to explain to the patient that they may observe brief bed rest during intense pain, but this is a way to reduce pain, not a method of treatment [47].

Comments. Informing the patient about a favorable prognosis of discogenic radiculopathy and maintaining physical activity prevents catastrophizing the subjective perception of the disease and promotes recovery. A prolonged decrease in professional, social, and daily activity worsens the prognosis and course of the disease.

Therapeutic physical exercise for diseases of the peripheral nervous system is recommended for patients with discogenic radiculopathy when pain subsides (LEL – 1, GRD - A), because it can reduce pain and improve the functional state of patients [45,48,49]. No advantages of a specific type of exercise have been noted; its implementation requires supervision by a specialist, and the load must be adequate to the patient's condition [45,48,49]. Maintaining physical activity reliably promotes recovery and positively affects the general condition of patients [50].

Comments. Therapeutic physical exercise is a complex of dynamic and/or static exercises, including aerobic loads, methods of static and dynamic muscle strengthening, mobilization exercises, as well as general conditioning exercises. Therapeutic physical exercise has a positive effect on the general health of patients, preventing recurring episodes of pain, and is devoid of serious side effects if performed under the supervision of a specialist, taking into account the functional capabilities of the patient.

Manual therapy for diseases of the peripheral nervous system is recommended for patients with subacute and chronic discogenic radiculopathy (LEL – 1, GRD - A), as its use can reduce pain and improve the functional state of patients [51–55]. The positive effect of manual therapy on pain and the functional state of patients has been noted compared to sham therapy in small studies [52,55]. In acute discogenic radiculopathy, manual therapy is associated with the risk of increased herniation size according to MRI data [51]. Manual therapy is recommended by US experts [41] and Danish experts [42], in combination with therapeutic physical exercise in the UK [40], but is not recommended by experts in some European countries [55].

Comments. Among manual therapy methods, soft tissue techniques are the safest; their application must take into account the patient's condition. Manual therapy can lead to increased pain and worsening of functions due to additional impact on musculoskeletal structures, but these complications are transient; serious complications (fractures, cauda equina root compression, vascular complications) are rare [51,52,55].

Psychological methods of therapy, including cognitive behavioral therapy and mindfulness therapy (clinical and psychological adaptation, clinical and psychological counseling, clinical and psychological correction, clinical and psychological training), are recommended in patients with chronic discogenic radiculopathy (LEL – 1, GRD - B), because they reduce pain and improve the functional state of patients with chronic back pain [56–60]. Psychological treatment methods must be combined with therapeutic physical exercise [40].

Comments. Psychological methods are used primarily in specialized centers for the treatment of patients with chronic back pain.

Reflexology for diseases of the peripheral nervous system is recommended in chronic discogenic radiculopathy (LEL – 1, GRD - A), because it can reduce pain and improve the functional state of patients. Reflexology is not associated with serious adverse events [53,61,62]. Reflexology is not recommended for discogenic radiculopathy by experts in some countries [40,42] due to its unproven efficacy.

Comments. Reflexology is likely effective in patients who have previously had a positive experience with its use for discogenic radiculopathy or other conditions.

Massage of the lower back and lower limb muscles (medical lower limb massage, lower limb and lower back massage, lumbosacral spine massage, medical back massage) is recommended in patients with chronic discogenic radiculopathy (LEL – 1, GRD - A); some studies have noted a decrease in pain intensity after massage [63].

Comments. Massage remains one of the most widespread methods of treating patients with back pain in our country, and many patients associate significant improvement in their condition with massage. However, it is not recommended by experts in various countries for the management of patients with degenerative lumbosacral radiculopathy due to the lack of sufficient evidence of its efficacy [40-42].

Various methods of physiotherapeutic treatment. Some studies have noted the efficacy of pulsed low-frequency electromagnetic field therapy in chronic degenerative lumbosacral radiculopathy; this method is recommended as part of combination therapy to reduce pain intensity and improve impaired functions (Evidence Level – 2, Recommendation Grade - B) [64, 65].

Traction (skeletal, underwater, and spinal traction) is not recommended for degenerative lumbosacral radiculopathy (Evidence Level – 1, Recommendation Grade - A), as no evidence of its efficacy has been obtained [45, 66].

The wearing of corsets, braces, belts, and other special orthopedic devices that immobilize the lumbosacral spine is not recommended for patients with degenerative lumbosacral radiculopathy (Evidence Level – 5, Recommendation Grade - C), as these methods do not relieve pain or improve patients' functional activity [45, 53, 127].

Comments. The wearing of corsets, braces, belts, and other special orthopedic devices and traction are also not recommended by experts from various countries for the management of patients with degenerative lumbosacral radiculopathy [40-42]. The wearing of corsets, braces, belts, and other special devices is recommended if there are indications for orthopedic correction, regardless of the presence of degenerative lumbosacral radiculopathy.

3.1.2 Pharmacotherapy

Nonsteroidal anti-inflammatory and antirheumatic drugs (NSAIDs); ATC code: M01A** (drugs with analgesic, anti-inflammatory, and antipyretic effects) are recommended for patients with acute, subacute, or acute exacerbation of degenerative lumbosacral radiculopathy (Evidence Level – 1, Recommendation Grade - A), as they are capable of reducing pain and improving the functional state of patients [67-70]. It is recommended to prescribe NSAIDs at effective doses for the minimum necessary number of days in order to reduce the risk of adverse effects [71-73]. Currently, no reliable advantage of any single NSAID over others regarding back pain relief has been established [70-73]. The use of oral NSAID formulations is preferable, as parenteral administration has no advantages in terms of efficacy but is significantly inferior in safety [72, 73]. For acute high-intensity pain, short-term use of a combination drug containing diclofenac + orphenadrine is possible [74].

Comments. The prescription of NSAIDs is the most common management strategy for patients with acute and subacute dorsalgia [9]. When choosing an NSAID, it is necessary to take into account the presence and nature of risk factors for adverse events, concomitant diseases, and drug-drug interactions. NSAIDs should not be combined with each other or used long-term (it is advisable to limit treatment to 10–14 days), which significantly reduces the risk of complications from the gastrointestinal tract, cardiovascular, and other systems. NSAIDs are contraindicated in erosive and ulcerative lesions of the gastrointestinal tract, especially in the acute phase, severe hepatic and renal impairment, individual intolerance, pregnancy, and severe heart failure. In patients at risk for gastrointestinal complications, it is recommended to use NSAIDs with the lowest risk of such complications (meloxicam, nimesulide, aceclofenac, and coxibs (M01AH) (celecoxib, etoricoxib) [75-79], at low doses and for a short duration, and/or to consider gastroprotection for the prevention of such complications [73]. When choosing a specific NSAID, it is necessary to check the package leaflet for the relevant indication and the absence of contraindications.

Antiepileptic drugs (ATC code: N03AX; gabapentin, pregabalin**) are recommended for pain reduction in degenerative lumbosacral radiculopathy (Evidence Level – 2, Recommendation Grade - B), given their positive effect on neuropathic pain. A number of studies have shown the superiority of gabapentin and pregabalin** over placebo in acute and chronic degenerative lumbosacral radiculopathy [80-84]. However, according to a systematic review, no efficacy of antiepileptic drugs was noted in this disease [85].

Antidepressants (non-selective monoamine reuptake inhibitors: amitriptyline**, ATC code: N06AA; duloxetine, ATC code: N06AX21) are recommended for patients with chronic degenerative lumbosacral radiculopathy (Evidence Level – 2, Recommendation Grade - A) because they exert an analgesic effect in chronic back pain [67, 86, 87, 118, 119, 120]. The use of antidepressants is most justified when a comorbid depressive disorder is identified.

Comments. The use of antidepressants (duloxetine and non-selective monoamine reuptake inhibitors) remains one of the possible treatment methods for chronic non-specific back pain in combination with exercise therapy. At the same time, experts in a number of countries do not recommend antidepressants for degenerative lumbosacral radiculopathy [40-42].

B vitamins (Vitamin B1 in combination with vitamins B6 and/or B12, ATC code: A11DB) are recommended for acute degenerative lumbosacral radiculopathy in combination with NSAIDs to reduce pain (Evidence Level – 2, Recommendation Grade - B), because the addition of B vitamins to NSAIDs may provide an additional analgesic effect [88-91].

Comments. B vitamins are used in our country for degenerative lumbosacral radiculopathy, and the instructions for medical use contain a corresponding indication (radiculopathy, radicular syndromes).

Centrally acting muscle relaxants (ATC code: M03BX; tolperisone, tizanidine**, cyclobenzaprine) are recommended for degenerative lumbosacral radiculopathy (Evidence Level – 1, Recommendation Grade - B) if there are additional musculoskeletal causes of pain for which they have proven efficacy [92-94]. Currently, no superiority of any single muscle relaxant over others regarding back pain reduction has been established [92-94].

Comments. Muscle relaxants are not combined with each other. The potential sedative effect of muscle relaxants should be taken into account.

Glucocorticoids (glucocorticoids, ATC code: H02AB)** orally, intramuscularly, or intravenously are not recommended for degenerative lumbosacral radiculopathy (Evidence Level – 1, Recommendation Grade - A) because they only transiently reduce pain [67, 95] and can cause serious adverse events.

Paracetamol** (other analgesics and antipyretics, ATC code: N02B) is not recommended as a standalone treatment for degenerative lumbosacral radiculopathy (Evidence Level – 1, Recommendation Grade - A), because there is no convincing evidence of its efficacy in back pain [96, 97].

Opioids (ATC code: N02A) are not recommended for degenerative lumbosacral radiculopathy (Evidence Level – 1, Recommendation Grade - B) because their effect is short-lived [40, 67], and serious adverse events and drug dependence are possible.

Nevertheless, a number of opioids, for example, tramadol**, tapentadol**, are recommended for relief of intolerable high-intensity pain when it is impossible to do so by other means (Evidence Level – 1, Recommendation Grade - B) [41].

3.2. Surgical treatment

Discectomy using microsurgical technique, open or minimally invasive (endoscopic), is recommended for patients with dorsalgia if conservative therapy fails within 6–12 weeks (LOC – 2, GOR – A), because its superiority in reducing pain and improving functional activity in patients compared to continued conservative treatment has been proven [98-100].

Emergency surgical treatment is recommended in the early stages (the first days of the disease) in the presence of cauda equina syndrome (pelvic organ dysfunction, perineal numbness, foot weakness) (Evidence Level – 2, Recommendation Grade - B) because it reduces pain and prevents disability [2, 99, 100]. Microsurgical discectomy results in mortality less often than other spinal surgeries (less than 1 case per 1000 operations), causes the appearance or worsening of neurological deficit in 1-3%, and is accompanied by wound complications in 1-2% [101]. The reoperation rate can reach 10% [100]. The results of surgical treatment are worse if degenerative lumbosacral radiculopathy is accompanied by manifestations of depression or psychosocial distress [7]. It has not been proven that surgical treatment is more effective than conservative therapy in reducing pain and increasing functional activity in the long term (1-4 years) from the onset of the disease [99, 102, 103].

Comments. In pronounced manifestations of degenerative lumbosacral radiculopathy, microsurgical discectomy provides more effective symptom relief than conservative or minimally invasive (e.g., epidural injections) treatment methods. Patients offered surgical treatment must be informed about the risks of complications associated with the surgery and the possibility of complete recovery without surgery

3.3. Other treatment

Epidural glucocorticoid injection is recommended for patients with acute and subacute lumbosacral disc herniation (Level of Evidence – 1, Grade of Recommendation - A), because it may lead to pain reduction and improve patients' functional activity [6,7,24,104]. Epidural GC injection is advisable for significant pain intensity and in the early stages of the disease [6]. The identified adverse effects of GCs with epidural administration are minimal or absent [122, 123]. Various administration techniques are possible (caudal, transforaminal, interlaminar) [105-107]. Epidural GC injection should preferably be performed under X-ray or ultrasound guidance, which increases the accuracy of the procedure [7,106]. Epidural GC injections should be administered at no more than two nerve root levels during a single procedure and no more than 4 times a year [103,107].

Comments. The epidural GC injection procedure must be performed by a specially trained professional with appropriate skills, in a room equipped for epidural GC administration and having all the necessary supplies for emergency care in case of potential complications. The efficacy of epidural GC injection in lumbosacral disc herniation is determined not by the type of herniation, but by the degree of nerve root compression. This manipulation is less effective in cases of severe compression of root structures.

Spinal cord stimulation is recommended for patients with chronic lumbosacral disc herniation who have not achieved a positive effect from all other treatment methods, including microdiscectomy (Level of Evidence – 2, Grade of Recommendation - B), as it can reduce pain and improve patients' functional status [108-111].

The administration of various medications into the intervertebral disc is not recommended for lumbosacral disc herniation (Level of Evidence – 5, Grade of Recommendation - C), because it lacks convincing evidence of efficacy and is associated with a risk of complications [112].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Medical rehabilitation is recommended for all patients with lumbosacral disc herniation. Rehabilitation may include exercise therapy for diseases of the peripheral nervous system [45, 48, 49], manual therapy for diseases of the peripheral nervous system [51, 52, 55], pulsed low-frequency electromagnetic field therapy [64, 65] (Level of Evidence – 2, Grade of Recommendation - B), (see section "Non-pharmacological treatments").

Sanatorium-resort treatment is recommended for patients with chronic lumbosacral disc herniation and may include therapeutic mineral baths and pelotherapy (mud therapy) (Level of Evidence – 1, Grade of Recommendation - B), because these methods are effective in the comprehensive treatment of chronic back pain. They are contraindicated in concomitant oncological diseases, decreased blood clotting, cardiovascular diseases with pronounced functional disorders, and benign neoplasms prone to growth [113-116].

5. Prevention and Dispensary Observation

To prevent lumbosacral disc herniation, it is recommended to avoid excessive physical exertion (heavy lifting, carrying a heavy bag in one hand, etc.) and hypothermia (Level of Evidence – 1, Grade of Recommendation - A) — excessive physical exertion and hypothermia are identified as risk factors for back pain [117].

Patients with lumbosacral disc herniation are advised to avoid prolonged static loads (prolonged sitting, staying in an uncomfortable position, etc.) (Level of Evidence – 1, Grade of Recommendation - A), because prolonged static loads are identified as risk factors for non-specific low back pain [117].

To prevent recurrence of lumbosacral disc herniation, regular exercise therapy, therapeutic swimming in a pool, and terrain cure (walking therapy) are recommended (Level of Evidence – 1, Grade of Recommendation - A), because these treatments are proven as methods for preventing non-specific low back pain [117].

6. Organization of Medical Care

Indications for planned hospitalization:

1) Lack of effect from outpatient conservative therapy;

2) Presence of lower limb paresis;

3) Severe disability due to pain.

Indications for emergency hospitalization:

1) Suspended cauda equina compression syndrome;

2) Suspended spinal fracture;

3) Suspended spinal or spinal cord tumor;

4) Suspended inflammatory spinal disease.

Indications for patient discharge from the hospital:

1) Reduction of pain intensity according to the VAS, VRS, or NRS;

2) Reduction in the degree of functional impairment according to the Roland-Morris or Oswestry questionnaire;

3) Lack of response to treatment in the neurological department, recommendation for surgical treatment.

7. Additional Information

Obesity, smoking, depression, anxiety, catastrophizing, and sleep disorders are modifiable risk factors for chronic pain. Timely identification of these factors in patients with lumbosacral disc herniation and intervention targeting them is recommended, as it improves the prognosis for recovery and prevents subsequent exacerbations [124-126, 128-132] (Level of Evidence – 4, Grade of Recommendation - C).

Criteria for Evaluating the Quality of Medical Care

References

Appendix A1. Working Group Composition

Conflict of interest: none.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

1. Anesthesiologists-intensivists

2. Manual therapy physicians

3. Neurologists

4. Neurosurgeons

5. General practitioners (family physicians)

6. Osteopaths

7. Exercise therapy physicians

8. Medical rehabilitation physicians

9. Rheumatologists

10. Reflexotherapists

11. Internists

12. General practitioners / district physicians

13. Trauma and orthopedic surgeons

14. Physiotherapists

15. Physical and rehabilitation medicine physicians

Methods used for evidence collection/selection:

Search in electronic databases.

Description of methods used for evidence collection/selection:

The evidence base for the recommendations consists of publications included in the Cochrane Library, EMBASE, and MEDLINE databases. The search depth was 10 years.

Methods used to assess the quality and strength of evidence:

Expert consensus;

Significance assessment according to tables P1, P2, and P3.

Table P1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)

Table P2. Levels of Evidence (LoE) grading scale for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)

Table P3. Scale for grading grades of recommendation (GR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)

Consultation and peer review:

The preliminary version was posted for broad discussion on the website of the Russian Society for the Study of Pain (www.painrussia.ru) to give the widest possible range of individuals the opportunity to participate in discussing and improving the guidelines.

Working Group:

For the final revision and quality control, the recommendations were re-evaluated by the members of the working group, who concluded that all comments and feedback from the experts had been taken into account and the risk of bias in the development of the recommendations was minimized.

Procedure for updating clinical guidelines:

The mechanism for updating clinical guidelines provides for their systematic revision at least once every 2 years.

Appendix A3. Reference Materials

These clinical guidelines were developed taking into account the following regulatory legal documents:

- Procedure for the provision of medical care to the adult population for nervous system diseases (Order of the Ministry of Health of the Russian Federation No. 926n dated November 15, 2012).

- Order of the Russian Ministry of Health No. 203n dated May 10, 2017, "On Approval of Criteria for Assessing the Quality of Medical Care"

- CG400. Chronic pain syndrome (CPS) in adult patients requiring palliative medical care.

These clinical guidelines were developed taking into account the following methodological materials and interdisciplinary specialist consensuses:

- Nasonov E.L., Yakhno N.N., Karateev A.E., et al. General principles for the treatment of musculoskeletal pain: an interdisciplinary consensus. Scientific and Practical Rheumatology. 2016;54(3):247-265.

- Karateev A.E., Nasonov E.L., Ivashkin V.T., et al. Rational use of nonsteroidal anti-inflammatory drugs. Clinical guidelines. Scientific and Practical Rheumatology. 2018; 56: 1-29.

- Davydov O.S., Yakhno N.N., Kukushkin M.L., Churyukanov M.V., et al. Neuropathic pain. Clinical guidelines for diagnosis and treatment. Russian Journal of Pain. 2018. No. 4 (57). P. 5-41.

These clinical guidelines were developed taking into account the indications for use, contraindications, routes of administration, and doses of medicinal products in accordance with the instructions for medical use contained in the State Register of Medicinal Products — www.grls.rosminzdrav.ru

Appendix B. Physician Action Algorithms

Appendix C. Patient Information

Discogenic lumbosacral radiculopathy is a medical term describing pain and neurological disorders caused by spinal nerve root damage ("pinched nerve").

However, it is important to know that disc herniations are very common in people without any complaints and do not require special treatment. The diagnosis of radiculopathy is established by a physician based on complaints (back pain radiating to the leg), detection of sensory and motor deficits, and reflex changes.

When to see a doctor?

If you develop back pain radiating to the leg, accompanied by numbness, tingling, or limb muscle weakness.

If this is accompanied by urination disorders (urinary retention or incontinence), defecation disorders, or perineal numbness, you should consult a doctor immediately!

Are additional diagnostic tests necessary?

Consultation with a physician involving a history-taking, evaluation of complaints, somatic status, and nervous system status makes it possible to establish a diagnosis and prescribe treatment without instrumental and laboratory tests. If the physician detects signs of another disease during the examination, they will prescribe the necessary diagnostic methods.

Magnetic resonance imaging (MRI) is most commonly used to detect disc herniation. If you have contraindications to MRI (e.g., metal objects in the body, a pacemaker), X-ray computed tomography can be used. Routine radiography does not allow for the diagnosis of disc herniation.

How is radiculopathy treated?

Discogenic lumbosacral radiculopathy has a favorable prognosis due to the gradual reduction of the disc herniation and associated non-infectious inflammatory changes. In most cases, pain decreases and working capacity is restored within a few weeks.

It is very important to maintain daily activity as much as possible because it promotes faster recovery; conversely, prolonged (more than 3–5 days) bed rest delays recovery. It is essential to learn the correct technique for performing certain movements (e.g., lifting objects from the floor) and exercises to optimize muscle condition, as demonstrated by exercise therapy (rehabilitation) physicians.

To reduce pain, the doctor may prescribe nonsteroidal anti-inflammatory drugs (by prescription). If their effect is insufficient, they can be supplemented with more potent medications (by prescription).

If even this is insufficient, painkillers can be injected into the area of spinal nerve root compression; this procedure is performed only in specialized centers by qualified specialists who have undergone appropriate training.

Is surgery necessary?

In rare cases, when urination and defecation disorders and leg weakness occur, emergency surgery is required. In most cases, surgical treatment is considered if pain does not decrease and working capacity is not restored within 6–12 weeks. In such cases, a neurosurgeon consultation is necessary to assess the need for surgery. Surgery allows for the removal of the disc herniation, "freezing" (freezing -> releasing) the nerve root. The scope of surgery, as well as its risks, is determined individually, depending on the severity of symptoms, the location of the herniation, and overall health status. Surgical treatment allows for faster pain relief and restoration of working capacity compared to continuing conservative treatment. However, over a long-term period (1 year or more from the onset of the disease), there are no significant differences between individuals who underwent surgical treatment and those who continued conservative treatment.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Appendix G 1. Symptoms of lumbar and sacral nerve root involvement

Appendix G 2. Pain Intensity Rating Scales

Russian name: visual analog scale (VAS), numeric rating scale (NRS), verbal rating scale (VRS)

Original name: Visual Analog Scale, Numeric Rating Scale, Verbal Rating Scale

Sources:

A.Williamson, B. Hoggart: Pain: a review of three commonly used pain rating scales. Journal of Clinical Nursing. 14:798-804 2005.

Pain: A guide for students and physicians : textbook / ed. by RAMS Academician N.N. Yakhno. — M. : MEDpress-inform, 2010. — 304 p.

Type – scale

Purpose: assessment of pain intensity

Explanation: The VAS is a 10 cm (100 mm) line on which the patient is asked to make a mark corresponding to the intensity of pain experienced at the moment (or over a certain period, e.g., the last week), with the patient choosing between "no pain" and "unbearable pain". Then, the distance between the start of the scale ("no pain") and the patient's mark is measured with a ruler, and centimeters are then converted into points (1 cm = 10 mm = 1 point).

The NRS is similar to the VAS and is a modification of it. The patient marks one of 11 (sometimes a gradation from 0 to 10 is used) points on the scale corresponding to the current intensity of their pain.

The VRS consists of adjectives describing pain, arranged in order of increasing intensity. Sometimes a scale containing both adjectives and numerical designations is used (0 – "no pain", 1 – "mild", 2 – "moderate", 3 – "severe", 4 – "very severe", 5 – "unbearable"). The algorithm of use is the same as for the VAS.

Appendix G 3. Clinical Examination with Neurological Status Assessment

Assessment of somatic status in patients with discogenic lumbosacral radiculopathy is carried out according to generally accepted standards; they are aimed at identifying a specific disease (tumor, trauma, infection, or other condition) that may manifest as back pain.

The Wasserman and Mauthner tests are also of diagnostic value. Wasserman's sign — the appearance of pain along the anterior surface of the thigh when lifting the straightened leg upward in a patient lying on their stomach — indicates the possibility of upper and middle lumbar root involvement. Mauthner's sign — the appearance of pain alongடைய the anterior surface of the thigh when flexing the lower leg in a patient lying on their stomach — indicates the possibility of lower lumbar root involvement.

Comments. "Tension" tests indicate damage to the lumbar and sacral roots, but do not allow determining the lesion of a specific root. Based solely on a neurological examination, it is difficult to differentiate between radiculopathy and lumbosacral plexus lesions in patients without a clear clinical picture of radicular pain syndrome.

Appendix G 4. Muscle Strength Grading Scale

Russian title: Medical Research Council (MRC) Muscle Strength Scale

Original title: Medical Research Council (MRC) Weakness Scale

Sources:

Medical Research Council. Aids to the examination of the peripheral nervous system, Memorandum no. 45, Her Majesty’s Stationery Office, London, 1981.

https://mrc.ukri.org/research/facilities-and-resources-for-researchers/mrc-scales/mrc-muscle-scale/

van der Ploeg RJ, Osterhuis HJ, Reuvekamp J. Measuring muscle strength. J Neurol. 1984;231(4):200‐203.

A.N. Belova. Scales, Tests, and Questionnaires in Neurology and Neurosurgery. Moscow: Prakticheskaya Meditsina, 2018. — 696 p.

Type – rating scale

Purpose: assessment of muscle strength in points

Explanation: a six-point scale (from 5 to 0) is used to assess the strength of individual muscles and muscle groups. A comparative assessment of the affected and healthy sides is performed. A score of 5 indicates no paresis. Paresis is defined as mild if strength corresponds to 4 points, moderate to 3 points, pronounced to 2 points, severe to 1 point, and paralysis to 0 points. It can be used dynamically; the modified scale allows calculating the ratio of muscle strength between the healthy and affected sides as a percentage.

Appendix G 5. Oswestry Disability Index

Russian title: Oswestry Questionnaire

Original title: The Oswestry low back pain disability questionnaire.

Sources:

Fairbank J.C., Couper J., Davies J.B., et al. The Oswestry low back pain disability questionnaire // Physiotherapy. 1980. Vol. 66. P. 271–273.

Bakhtadze M.A., Bolotov D.A., Kuzminov K.O. Low back pain disability index (Oswestry questionnaire): assessment of reliability and validity of the Russian version. Manualnaya Terapiya, 2016.-N 4.-P.24-33.

Cherepanov V.A. The Russian version of the Oswestry questionnaire: cultural adaptation and validity. Hirurgia Pozvonochnika 2009;(3):93–98.

Type – questionnaire

Purpose: Assessment of the degree of functional impairment (disability) in chronic lower back pain

Explanation: The Oswestry questionnaire consists of 10 sections. In each section, the first answer is the minimum score (0), and subsequent answers are 1, 2, 3, 4, and 5 points, respectively. When all 10 sections are completed, the Oswestry index is calculated as follows: sum of scores / 50 (maximum possible score) × 100 =. If one of the sections is not filled out or cannot be assessed (e.g., sex life), the Oswestry index is calculated as follows: sum of scores / 45 (maximum possible score) × 100 =. The higher the index, the more significant the disability. The questionnaire can also be used to assess the patient's condition dynamically, for example, during therapy.

Appendix G 6. Roland-Morris Disability Questionnaire

Russian title: Roland-Morris Questionnaire

Original title: Roland-Morris Disability Questionnaire, RDQ

Sources:

Roland M.O., Morris R.W. A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low back pain //Spine. – 1983. – Vol. 8. – P. 141–144.

Tarakanov A.A., Efremov V.V. Instrumental validation of the "Low Back Pain and Disability (Roland-Morris)" questionnaire. Russian Journal of Pain: 2 (56); 2018. pp. 96-97.

Type – questionnaire

Purpose: assessment of the impact of lower back pain on disability.

Check only those statements that describe your condition today.

Note: The Roland-Morris questionnaire consists of 24 items answered by the patient. The total number of items checked by the patient is calculated, yielding a possible score from 0 to 24. The higher the number of checked items, the greater the impairment in the patient's daily functioning. To monitor treatment dynamics, the questionnaire can be completed again, and the number of items showing improvement can be converted into a percentage.