| Literature DB >> 20949289 |
Wilco C H Jacobs1, Maurits van Tulder, Mark Arts, Sidney M Rubinstein, Marienke van Middelkoop, Raymond Ostelo, Arianne Verhagen, Bart Koes, Wilco C Peul.
Abstract
The effectiveness of surgery in patients with sciatica due to lumbar disc herniations is not without dispute. The goal of this study was to assess the effects of surgery versus conservative therapy (including epidural injections) for patients with sciatica due to lumbar disc herniation. A comprehensive search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to October 2009. Randomised controlled trials of adults with lumbar radicular pain, which evaluated at least one clinically relevant outcome measure (pain, functional status, perceived recovery, lost days of work) were included. Two authors assessed risk of bias according to Cochrane criteria and extracted the data. In total, five studies were identified, two of which with a low risk of bias. One study compared early surgery with prolonged conservative care followed by surgery if needed; three studies compared surgery with usual conservative care, and one study compared surgery with epidural injections. Data were not pooled because of clinical heterogeneity and poor reporting of data. One large low-risk-of-bias trial demonstrated that early surgery in patients with 6-12 weeks of radicular pain leads to faster pain relief when compared with prolonged conservative treatment, but there were no differences after 1 and 2 years. Another large low-risk-of-bias trial between surgery and usual conservative care found no statistically significant differences on any of the primary outcome measures after 1 and 2 years. Future studies should evaluate who benefits more from surgery and who from conservative care.Entities:
Mesh:
Substances:
Year: 2010 PMID: 20949289 PMCID: PMC3065612 DOI: 10.1007/s00586-010-1603-7
Source DB: PubMed Journal: Eur Spine J ISSN: 0940-6719 Impact factor: 3.134
Search strategy for Pubmed/MEDLINE for identification of primary studies on surgery versus conservative treatment for sciatica
| 1 | randomised controlled trial.pt. |
| 2 | controlled clinical trial.pt. |
| 3 | randomised.ab. |
| 4 | placebo.ab,ti. |
| 5 | drug therapy.fs. |
| 6 | randomly.ab,ti. |
| 7 | trial.ab,ti. |
| 8 | groups.ab,ti. |
| 9 | or/1–8 |
| 10 | (animals not (humans and animals)).sh. |
| 11 | 9 not 10 |
| 12 | dorsalgia.ti,ab. |
| 13 | exp Back Pain/ |
| 14 | backache.ti,ab. |
| 15 | (lumbar adj pain).ti,ab. |
| 16 | coccyx.ti,ab. |
| 17 | coccydynia.ti,ab. |
| 18 | sciatica.ti,ab. |
| 19 | sciatica/ |
| 20 | spondylosis.ti,ab. |
| 21 | lumbago.ti,ab. |
| 22 | exp low back pain/ |
| 23 | Or/12–22 |
| 24 | 11 and 23 |
| 25 | limit 24 to ed = 20080501–20081223 |
Search strategy was adapted for other databases
Items from the risk-of-bias tool and criteria for operationalisation
| Question | Criteria for “Yes” |
|---|---|
| Was the method of randomisation adequate? | A random (unpredictable) assignment sequence. Examples of adequate methods are coin toss, rolling a dice, drawing of ballots with the study group labels from a dark bag, computer-generated random sequence, pre-ordered sealed envelopes and sequentially-ordered vials. Examples of inadequate methods are: alternation, birth date, social insurance/security number and hospital registration number |
| Was the treatment allocation concealed? | Assignments are generated by an independent person not responsible for determining the eligibility of the patients. This person has no information about the persons included in the trial and has no influence on the assignment sequence or on the eligibility decision of the patient |
| Were the groups similar at baseline regarding the most important prognostic indicators? | The groups have to be similar at baseline regarding demographic factors, duration and severity of complaints, percentage of patients with neurological symptoms, and value of main outcome measure(s) |
| Was the patient blinded to the intervention? | The index and control groups are indistinguishable for the patients |
| Was the care provider blinded to the intervention? | The index and control groups are indistinguishable for the care providers |
| Was the outcome assessor blinded to the intervention? | • For patient-reported outcomes with adequately blinded patients |
| • For outcome criteria that supposes a contact between participants and outcome assessors: the blinding procedure is adequate if patients are blinded, and the treatment or adverse effects of the treatment cannot be noticed during examination | |
| • For outcome criteria that do not suppose a contact with participants: the blinding procedure is adequate if the treatment or adverse effects of the treatment cannot be noticed during the assessment | |
| • For outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers, in which the care provider is the outcome assessor: the report needs to be free of selective outcome reporting | |
| Were co-interventions avoided or similar? | There were no co-interventions or they were similar between the index and control groups |
| Was the compliance acceptable in all groups? | The compliance with the interventions is acceptable, based on the reported intensity, duration, number and frequency of sessions for both the index intervention and control intervention(s). For single-session interventions (for ex: surgery), this item is irrelevant |
| Was the drop-out rate described and acceptable? | The number of participants who were included in the study but did not complete the observation period or were not included in the analysis are described and reasons are given and are <20% for short-term and <30% for long-term follow-up |
| Was the timing of the outcome assessment similar in all groups? | Timing of outcome assessment was identical for all intervention groups and for all important outcome assessments |
| Were all randomised participants analysed in the group to which they were allocated? | All randomised patients are reported/analysed in the group they were allocated to by randomisation for the most important moments of effect measurement (minus missing values) irrespective of non-compliance and co-interventions |
Overview risk of bias for surgical, including epidural injections versus conservative therapy
| References | Randomisation adequate? | Allocation concealed? | Groups similar at baseline? | Patient blinded? | Care provider blinded? | Outcome assessor blinded? | Co-interventions avoided or similar? | Compliance acceptable? | Drop-out rate described and acceptable? | Timing outcome assessment similar? | Intention-to-treat analysis? | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Buttermann [ | ? | ? | + | − | − | − | − | na | − | − | ? | 1 |
| Osterman [ | + | + | − | − | − | − | − | na | + | + | + | 5 |
| Peul [ | + | + | + | − | − | − | − | na | + | + | + | 6 |
| Weinstein [ | + | + | + | − | − | − | − | na | + | + | + | 6 |
| Weber [ | + | + | ? | − | − | − | ? | na | + | + | ? | 4 |
na not applicable
? = Unsure
Characteristics of the included studies: Surgery including epidural injections, versus conservative care
| References | Sample size | % Female | Average age (range) | Participants | Interventions | Outcomes | Follow-up |
|---|---|---|---|---|---|---|---|
| Buttermann [ | 169 | ? | 40 | Between 18 and 70 years | Exp: Epidural steroid injections | Neurological status | 1–3 months |
| Lumbar disc herniation [>25% of the CSA of spinal canal (MRI or CT)] (at least 6 weeks) | Control: Lumbar discectomy | Current and lower extremity pain (VAS, 0–10) | 4–6 months | ||||
| ODI | 7–12 months | ||||||
| Type, frequency and change of medication | 1–2 years | ||||||
| Self-perceived recovery | 2–3 years | ||||||
| Satisfaction w/treatment | |||||||
| Osterman [ | 56 | 39% | 37.5 (20–50) | Below knee radicular pain of 6–12 weeks | Exp: Microdiscectomy (2 weeks) | Leg pain (VAS) (Pr) | 6 weeks |
| Intervertebral disc extrusion or sequester (CT) | Control: Conservative management | LBP and work ability (VAS) | 3 months | ||||
| Positive straight leg raising test <70°, muscle weakness, altered deep tendon reflex or dermatomal sensory change | 15D QoL | 1 and 2 years | |||||
| ODI | |||||||
| Risk of depression | |||||||
| Satisfaction with treatment | |||||||
| Perceived recovery | |||||||
| Clinical status | |||||||
| Peul [ | 283 | 44% | 41.7/43.4 | Aged 18–65 years | Exp: Early surgery (Discectomy, 2 weeks) | RMDQ (Pr) | 2, 4, 8, 12, 26 and 38 weeks |
| Lumbosacral radicular syndrome diagnosed by an attending neurologist for 6 to 12 weeks | Control: Prolonged conservative treatment with delayed surgery, if necessary (19 weeks) | Leg pain (VAS) (Pr) | 12, 18 and 24 months | ||||
| Radiologically confirmed disc herniation | Self-perceived recovery (Pr) | ||||||
| Dermatomal pattern of pain distribution with concomitant neurological disturbances that correlated to the same nerve root being affected | Neurological status | ||||||
| LBP (VAS) | |||||||
| PROLO scale | |||||||
| Weinstein [ | 501 | 42% | 42 | 18 years or older | Exp: Standard open discectomy | MOS SF 36 bodily pain and physical function (changes from baseline) (Pr) | 6 weeks |
| Radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations) at least 6 weeks | Control: Non-operative treatment, consisting of conservative care | ODI (Pr) | 3 months | ||||
| Evidence of nerve root irritation with a positive nerve root tension sign (straight leg raise positive between 30° and 70° or positive femoral tension sign) or a corresponding neurologic deficit | Sciatica Bothersomeness Index | 6 months | |||||
| Advanced vertebral imaging | Satisfaction with symptoms | 1 and 2 years | |||||
| Self-reported improvement | |||||||
| Employment status | |||||||
| Weber [ | 126 | 42% | 41.6 | Clinical signs/symptoms of 5th lumbar and/or 1st sacral nerve root lesion corresponding with radiculography (unknown duration) | Exp: Lumbar discectomy | Clinicians perception of recovery (working capacity, neurological deficits, pain, and mobility of the spine; relapse) | 1 years |
| Control: continued conservative treatment | 4 years | ||||||
| 10 years |
ODI Oswestry Disability Index, VAS visual analogue scale (in 100 mm, unless otherwise specified), LBP low back pain, RMDQ Roland and Morris disability questionnaire, MOS SF36 medical outcome study short form 36, Exp experimental therapy
? = Not reported
Results of the included studies: Surgery, including epidural injections, versus conservative care
| References | Group | Cross-over | Pain | Recovery | Good outcome | Qualitative short term | Qualitative long term |
|---|---|---|---|---|---|---|---|
| Buttermann [ | Epidural steroid injection | At 3 years: 58% | VAS leg pain [mean (SD)] (Inferred from graph) | NR | Successful treatment | Greater decrease in leg pain at 3 and 6 months for microdiscectomy | No differences at 1, 2 and 3 years for leg pain |
| At 2–3 years: 8 (12) | Various: 42–56% | ||||||
| Microdiscectomy | At 3 years: 4% | At 2–3 years: 15 (17) | NR | Various: 92–98% | |||
| Osterman [ | Conservative care | At 2 years: 39% | VAS Leg pain [ITT, mean (SD)]: | Recovered (number/total) | VAS Satisfaction | More rapid relief of leg pain at 6 weeks | No differences at 2 years leg pain, back pain and disability |
| At 1 year: 9 (19) | At 6 weeks: 0/26 | At 1 year: 85 (20) | |||||
| At 1 year 5/21 | |||||||
| Microdiscectomy | At 2 years: 0% | At 1 year: 6 (11) | At 6 weeks: 5/26 | At 1 year: 89 (20) | |||
| At 1 year: 7/20 | |||||||
| Peul [ | Prolonged conservative care | At 1 year: 39% | VAS leg pain [ITT, mean (SE)]: | Time to recovery | Likert (ITT, mean (SE)) | Better pain relief at 3 months for early surgery. No difference in disability. Faster time to recovery for early surgery | No differences at 1 and 2 years for recovery |
| At 8 weeks: 27.9 (1.9) | 12.1 weeks | At 8 weeks: 3.1 (0.1) | |||||
| At 1 year: 11.0 (1.9) | At 1 year: 2.1 (0.1) | ||||||
| Early surgery | At 1 year: 11% | At 8 weeks: 10.2 (1.9) | 4.0 weeks | At 8 weeks: 2.2 (0.1) | |||
| At 1 year: 11.0 (1.9) | At 1 year: 1.9 (0.1) | ||||||
| Weinstein [ | Conservative care | At 1 year: 41% | SF 36 pain [mean (SE)]: | NR | SRP (% (SE)): | - | No differences at 2 years on any outcome parameters |
| At 2 years: 45% | At 1 year: 36.9 (1.8) | At 1 year: 66.7 (3.2) | |||||
| At 2 years: 37.1 (1.9) | At 2 years: 69.3 (3.3) | ||||||
| Surgery | At 1 year: 57% | At 1 years: 39.7 (1.8) | NR | At 1 year: 75.7 (3.0) | |||
| At 2 years: 40% | At 2 years: 40.3 (1.9) | At 2 years: 76.3 (3.1) | |||||
| Weber [ | Usual conservative care | Constant; 26% | No pain (ITT, No pain/total): | NR | SRP (ITT, % good): | Better patient and observer ratings at 1 year for discectomy | No differences at 4 and 10 years |
| At 4 years: 45/66 | At 1 year: 36% | ||||||
| At 10 years: 65/66 | At 4 year: 52% | ||||||
| At 10 year: 56% | |||||||
| Surgery | Constant; 2% | At 4 years: 45/57 | NR | At 1 year: 65% | |||
| At 10 years: 54/55 | At 4 year: 70% | ||||||
| At 10 year: 64% |
ITT intention to treat, NR not reported, VAS visual analogue scale (in 100 mm, unless otherwise specified), SD standard deviation, SE standard error, SRP self rated progress, Likert Likert score for global perception of recovery