Introduction
Methods
Search methods for identification of studies
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 |
Criteria for considering studies for this review
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The study was stated to be a randomised controlled trial.
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The study compared surgery to non-surgical interventions (i.e. epidural injections, conservative therapy).
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The patients included were adult (>18 years of age) subjects with sciatica due to a herniated disc.
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The outcome(s) evaluated included at least one of the main clinically relevant outcome measures (i.e. pain, functional status, recovery, or sick leave) using a valid instrument.
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The follow-up was at least 1 day.
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The language was limited to English, Dutch and German.
Assessment of risk of bias for the included studies
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 |
Data collection and analysis
Results
Search and selection results
Risk-of-bias assessment
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 [2] | ? | ? | + | − | − | − | − | na | − | − | ? | 1 |
Osterman [12] | + | + | − | − | − | − | − | na | + | + | + | 5 |
Peul [13] | + | + | + | − | − | − | − | na | + | + | + | 6 |
Weinstein [22] | + | + | + | − | − | − | − | na | + | + | + | 6 |
Weber [19] | + | + | ? | − | − | − | ? | na | + | + | ? | 4 |
Effects of the interventions
References | Sample size | % Female | Average age (range) | Participants | Interventions | Outcomes | Follow-up |
---|---|---|---|---|---|---|---|
Buttermann [2] | 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 [12] | 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 [13] | 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 [22] | 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 [19] | 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 |
References | Group | Cross-over | Pain | Recovery | Good outcome | Qualitative short term | Qualitative long term |
---|---|---|---|---|---|---|---|
Buttermann [2] | 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 [12] | 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 [13] | 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 [22] | 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 [19] | 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% |