Abstract
Introduction
Herniated lumbar disc is a displacement of disc material (nucleus pulposus or annulus fibrosis) beyond the intervertebral disc space. The highest prevalence is among people aged 30 to 50 years, with a male to female ratio of 2:1. There is little evidence to suggest that drug treatments are effective in treating herniated disc.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of drug treatments, non-drug treatments, and surgery for herniated lumbar disc? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 37 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: acupuncture, advice to stay active, analgesics, antidepressants, bed rest, corticosteroids (epidural injections), cytokine inhibitors (infliximab), discectomy (automated percutaneous, laser, microdiscectomy, standard), exercise therapy, heat, ice, massage, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), percutaneous disc decompression, spinal manipulation, and traction.
Key Points
Herniated lumbar disc is a displacement of disc material (nucleus pulposus or annulus fibrosis) beyond the intervertebral disc space.
The highest prevalence is among people aged 30 to 50 years, with a male to female ratio of 2:1.
There is little high-quality evidence to suggest that drug treatments are effective in treating herniated disc.
NSAIDs and cytokine inhibitors do not seem to improve symptoms of sciatica caused by disc herniation.
We found no RCT evidence examining the effects of analgesics, antidepressants, or muscle relaxants in people with herniated disc.
We found several RCTs that assessed a range of different measures of symptom improvement and found inconsistent results, so we are unable to draw conclusions on effects of epidural injections of corticosteroids.
With regard to non-drug treatments, spinal manipulation seems more effective at relieving local or radiating pain in people with acute back pain and sciatica with disc protrusion compared with sham manipulation, although concerns exist regarding possible further herniation from spinal manipulation in people who are surgical candidates.
Neither bed rest nor traction seem effective in treating people with sciatica caused by disc herniation.
We found insufficient RCT evidence about advice to stay active, acupuncture, massage, exercise, heat, or ice to judge their efficacy in treating people with herniated disc.
About 10% of people have sufficient pain after 6 weeks for surgery to become a consideration.
Standard discectomy and microdiscectomy seem to increase self-reported improvement to a similar extent.
We found insufficient evidence judging the effects of automated percutaneous discectomy, laser discectomy, or percutaneous disc decompression.
Clinical context
About this condition
Definition
Herniated lumbar disc is a displacement of disc material (nucleus pulposus or annulus fibrosis) beyond the intervertebral disc space.[1] The diagnosis can be confirmed by radiological examination. However, MRI findings of herniated disc are not always accompanied by clinical symptoms.[2] [3] This review covers treatment of people with clinical symptoms relating to confirmed or suspected disc herniation. It does not include treatment of people with spinal cord compression, or people with cauda equina syndrome, which require emergency intervention. The management of non-specific acute low back pain and chronic low back pain are covered elsewhere in Clinical Evidence.
Incidence/ Prevalence
The prevalence of symptomatic herniated lumbar disc is about 1% to 3% in Finland and Italy, depending on age and sex.[4] The highest prevalence is among people aged 30 to 50 years,[5] with a male to female ratio of 2:1.[6] In people aged 25 to 55 years, about 95% of herniated discs occur at the lower lumbar spine (L4/5 and L5/S1 level); disc herniation above this level is more common in people aged over 55 years.[7] [8]
Aetiology/ Risk factors
Radiographical evidence of disc herniation does not reliably predict low back pain in the future, or correlate with symptoms; 19% to 27% of people without symptoms have disc herniation on imaging.[2] [9] Risk factors for disc herniation include smoking (OR 1.7, 95% CI 1.0 to 2.5), weight-bearing sports (e.g., weight lifting, hammer throw), and certain work activities, such as repeated lifting. Driving a motor vehicle has been suggested to be a risk factor for disc herniation, although evidence is inconclusive (OR 1.7, 95% CI 0.2 to 2.7).[6] [10] [11]
Prognosis
The natural history of disc herniation is difficult to determine, because most people take some form of treatment for their back pain, and a formal diagnosis is not always made.[6] Clinical improvement is usual in most people, and only about 10% of people still have sufficient pain after 6 weeks to consider surgery. Sequential MRIs have shown that the herniated portion of the disc tends to regress over time, with partial to complete resolution after 6 months in two-thirds of people.[12]
Aims of intervention
To relieve pain; increase mobility and function; improve quality of life; and minimise adverse effects of treatments.
Outcomes
Primary outcomes: pain, including global symptom relief; functional improvement; patient perception of improvement; quality of life; and adverse effects of treatment. Secondary outcomes: return to work; use of analgesia; and duration of hospital admission.
Methods
Clinical Evidence search and appraisal June 2010. The following databases were used to identify studies for this systematic review: Medline 1966 to June 2010, Embase 1980 to June 2010, and The Cochrane Database of Systematic Reviews, May 2010 (online; 1966 to date of issue). An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing >20 people of whom >80% were followed up. There was no minimum length of follow-up required to include trials. We excluded all trials described as "open", "open label", or not blinded unless blinding was impossible. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. The contributors used confidence interval analysis[13] and chi-square test analysis from PEPI version 4.0[14] in their own calculations, which are presented in the review. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table.
Important outcomes | Functional improvement, Need for surgery, Pain, Patient perception of improvement, Quality of life | ||||||||
Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
What are the effects of drug treatments for herniated lumbar disc? | |||||||||
8 (705) | Pain | Epidural corticosteroid injections versus no epidural corticosteroid injection | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for different results at different end points |
4 (386) | Functional improvement | Epidural corticosteroid injections versus no epidural corticosteroid injection | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
2 (417) | Patient perception of improvement | Epidural corticosteroid injections versus no epidural corticosteroid injection | 4 | 0 | –1 | –1 | 0 | Low | Consistency point deducted for different results at different end points. Directness point deducted for not defining outcome measured |
2 (213) | Need for surgery | Epidural corticosteroid injections versus no epidural corticosteroid injection | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for sparse data. Consistency point deducted conflicting results among trials. Directness point deducted for narrow included population |
1 (36) | Pain | Epidural corticosteroid plus conservative non-operative treatment versus conservative treatment alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for wide range of interventions used in comparison, making the results difficult to apply in clinical practice |
1 (36) | Functional improvement | Epidural corticosteroid plus conservative non-operative treatment versus conservative treatment alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for wide range of interventions used in comparison, making the results difficult to apply in clinical practice |
1 (36) | Need for surgery | Epidural corticosteroid plus conservative non-operative treatment versus conservative treatment alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for wide range of interventions used in comparison, making the results difficult to apply in clinical practice |
1 (100) | Pain | Epidural corticosteroid injection versus discectomy | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Consistency point deducted for different results at different end points |
1 (100) | Functional improvement | Epidural corticosteroid injection versus discectomy | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Consistency point deducted for different results at different end points |
1 (41) | Pain | Infliximab versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
1 (41) | Functional improvement | Infliximab versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results at 12 weeks |
1 (41) | Need for surgery | Infliximab versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
3 (321) | Pain | NSAIDs versus placebo | 4 | 0 | 0 | –2 | 0 | Low | Directness points deducted for limited range of NSAIDs assessed and for use of unclear outcome measure in meta-analysis |
1 (40) | Pain | NSAIDs versus electroacupuncture | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for possible inclusion of people without disc herniation and uncertainty about generalisability of outcomes measured |
1 (40) | Functional improvement | NSAIDs versus electroacupuncture | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for possible inclusion of people without disc herniation |
What are the effects of non-drug treatments for herniated lumbar disc? | |||||||||
1 (102) | Pain | Spinal manipulation versus placebo or sham treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
1 (102) | Functional improvement | Spinal manipulation versus placebo or sham treatment | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and for incomplete reporting of results |
1 (233) | Patient perception of improvement | Spinal manipulation versus heat treatment | 4 | –4 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and for methodological flaws (not reporting group baseline characteristics, uncertainty about intention-to-treat analysis, poor follow-up, and uncertainty about groups receiving equal number of treatments) |
1 (322) | Pain | Spinal manipulation versus exercise therapy | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and methodological flaws (not reporting group baseline characteristics and uncertainty about blinding). Directness point deducted for inclusion of people without herniated disc |
1 (322) | Patient perception of improvement | Spinal manipulation versus exercise therapy | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and methodological flaws (not reporting group baseline characteristics, uncertainty about blinding). Directness point deducted for inclusion of people without herniated disc |
1 (322) | Patient perception of improvement | Spinal manipulation versus traction | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and methodological flaws (not reporting group baseline characteristics and uncertainty about blinding). Directness point deducted for inclusion of people without herniated disc |
1 (112) | Functional improvement | Spinal manipulation versus traction | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and uncertainty about end point |
1 (30) | Pain | Acupuncture versus sham acupuncture | 4 | –2 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness points deducted for inclusion of people without disc herniation |
1 (42) | Pain | Laser acupuncture versus sham laser acupuncture | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for no long-term results and for inclusion of a wide population making it unclear whether the data are generalisable to herniated disc |
1 (58) | Pain | Adding acupuncture to manipulation compared with manipulation alone | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and for unspecified follow-up time. Directness point deducted for no long-term results |
2 (372) | Pain | Exercise therapy versus traction | 4 | –2 | 0 | –2 | 0 | Very low | Quality points deducted for incomplete reporting of results and lack of blinding in 1 RCT. Directness points deducted for poorly defined outcome measure in 1 RCT and for inclusion of people without herniated disc |
1 (40) | Functional improvement | Adding exercise plus education to conventional non-surgical treatment versus conventional non-surgical treatment alone | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for sparse data. Consistency point deducted as result sensitive to different methods of calculation |
1 (110) | Pain | Massage/manipulation versus massage/manipulation plus functional training exercises versus traction | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for unclear measurement of outcomes and for including spinal massage techniques (uncertainty about whether results using spinal techniques are comparable with results using other massage techniques) |
1 (110) | Pain | Massage/manipulation versus traction | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for unclear measurement of outcomes and for including spinal massage techniques (uncertainty about whether results using spinal techniques are comparable with results using other massage techniques) |
1 (183) | Pain | Bed rest versus no treatment (watchful waiting) | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted as results were only in people with sciatica, so there is uncertainty about generalisability of results to people with herniated lumbar disc |
1 (183) | Functional improvement | Bed rest versus no treatment (watchful waiting) | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted as results were only in people with sciatica, so there is uncertainty about generalisability of results to people with herniated lumbar disc |
1 (183) | Patient perception of improvement | Bed rest versus no treatment (watchful waiting) | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about generalisability of results for people with herniated lumbar disc |
1 (329) | Pain | Traction versus no traction or sham traction | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for incomplete reporting of results. Directness points deducted for inclusion of people without disc herniation and for inclusion of wide range of traction techniques and comparators |
1 (102) | Functional improvement | Traction versus no traction or sham traction | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for use of co-intervention |
1 (102) | Patient perception of improvement | Traction versus no traction or sham traction | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for use of co-intervention |
2 (93) | Functional improvement | Autotraction versus passive traction | 4 | –3 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results and no intention-to-treat analysis. Consistency point deducted for conflicting results, perhaps owing to different measures of outcome used |
What are the effects of surgery for herniated lumbar disc? | |||||||||
2 (339) | Pain | Microdiscectomy versus conservative treatment | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for methodological flaw (high crossover between interventions). Consistency point deducted for different results at different end points. Directness point deducted for multiple interventions in comparison |
2 (339) | Functional improvement | Microdiscectomy versus conservative treatment | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for methodological flaw (high crossover between interventions). Consistency point deducted for different results at different end points. Directness point deducted for multiple interventions in comparison |
1 (56) | Quality of life | Microdiscectomy versus conservative treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for multiple interventions in comparison |
1 (283) | Patient perception of improvement | Microdiscectomy versus conservative treatment | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for methodological flaw (high crossover between interventions). Consistency point deducted for different results at different end points. Directness point deducted for multiple interventions in comparison |
1 (60) | Pain | Video-assisted arthroscopic microdiscectomy versus standard discectomy | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
1 (60) | Patient perception of improvement | Video-assisted arthroscopic microdiscectomy versus standard discectomy | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for unclear outcome measure |
2 (627) | Pain | Standard discectomy versus conservative treatment | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for high crossover between treatments. Consistency point deducted for different results at different end points |
2 (627) | Functional improvement | Standard discectomy versus conservative treatment | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for high crossover between treatments. Consistency point deducted for different results at different end points |
5 (378) | Pain | Standard discectomy versus microdiscectomy | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for uncertainty about outcomes in 1 study and for uncertainty about baseline differences in another study |
1 (40) | Functional improvement | Standard discectomy versus microdiscectomy | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and unclear follow-up rate |
1 (60) | Patient perception of improvement | Standard discectomy versus microdiscectomy | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
1 (71) | Pain | Automated percutaneous discectomy versus microdiscectomy | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and premature termination of the trial. Directness point deducted for unclear outcome measure |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.
Glossary
- Automated percutaneous discectomy
Percutaneous disc decompression using a combined irrigation, suction, and cutting device inserted through a cannula.
- Autotraction
The person provides the traction force on the traction table by pulling on the bar on the head of the table while his or her pelvis is held by a girdle and chain to the lower end of the table.
- Cauda equina syndrome
Compression of the cauda equina, causing symptoms that include changes in perineal sensation (saddle anaesthesia) and loss of sphincter control. The cauda equina is a collection of spinal roots descending from the lower part of the spinal cord, which occupy the vertebral canal below the spinal cord.
- Japanese Orthopaedic Association (JOA) score
This score is for clinical symptoms in people with herniated lumbar disc. Functionality and pain are measured across 4 parameters, on a scale from −6 to +29, with higher scores indicating better outcomes: first, subjective symptoms (0–9 points; low back pain leg pain, tingling gait, or both); second, clinical signs (0–6 points; straight leg raising test sensory disturbance motor disturbance); third, restriction in activities (0–14 points; turn over while lying, standing, washing, leaning forward, sitting for about 1 hour, lifting or holding a heavy object, walking); and fourth, urinary bladder function (–6 points maximum).
- Laser discectomy
The surgeon places a laser through a delivery device that has been directed under radiographic control to the disc, and removes the disc material using the laser. It uses many of the same techniques used in automated percutaneous discectomy.
- Lasègue's sign
The limitation of straight leg raising in a supine position usually associated with lumbar nerve root compression. Also, in sciatica, added foot dorsiflexion to a straight leg raise results in more pain.
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Manual traction
A form of passive traction. The person lies supine on a plinth with varying degrees of flexion in the hip and knee joints. The traction force is exerted by the therapist using a belt placed around the therapist's back or hips and attached behind and below the person's knees. The traction force is adjusted by the therapist according to the patient's symptoms, with a maximum force of about 30 kg as measured by a force transducer in the belt.
- Microdiscectomy
Removal of protruding disc material, using an operating microscope to guide surgery.
- Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
- Oswestry Disability Index
Back-specific, self-reported questionnaire measuring pain and function in completing physical and social activities. The scale score ranges from 0 (no disability) to 100 (maximum disability).
- Passive traction
The person lies supine on a traction table with thighs flexed and supported by pillow over knees. The traction force is adjusted manually by the therapist to about 35% of person's body weight, measured by a dynamometer, and then maintained by a chain connection to the foot of the bed. The traction force is adjusted regularly during the treatment session.
- Percutaneous disc decompression
Any technique for discectomy performed through percutaneous portals inserted with x-ray control, generally removing intradiscal fragments rather than sequestrated extradiscal fragments.
- Roland Morris Disability Questionnaire
A 24-item, self-reported, disability scale specific to back pain recommended for use in primary care and community studies. Measures daily function in completing activities affected by back pain. The scale score ranges from 0 (no disability) to 24 (severe disability).
- Short Form (SF)-36
A health-related quality-of-life scale across 8 domains: limitations in physical activities (physical component), limitations in social activities, limitations in usual role activities owing to physical problems, pain, psychological distress and wellbeing (mental health component), limitations in usual role activities because of emotional problems, energy and fatigue, and general health perceptions.
- Standard discectomy
Surgical removal, in part or whole, of an intervertebral disc, generally with loop magnification (i.e., eyepieces).
- Very low-quality evidence
Any estimate of effect is very uncertain.
Chronic low back pain
Non-specific acute low back pain
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
Contributor Information
Joanne L Jordan, Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Keele, UK.
Kika Konstantinou, Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Keele, UK.
John O'Dowd, RealHealth Institute, London, UK.
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