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RCT
ACE Report #3058

Early surgery in sciatica patients results in improved pain relief and perceived recovery


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Surgery versus Prolonged Conservative Treatment for Sciatica

N Engl J Med. 2007 May 31;356(22):2245-56

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OE EXCLUSIVE

Dr. Wilco Peul discusses early surgery versus prolonged conservative treatment for sciatica.

Synopsis

283 patients with disc herniation and resulting sciatica were randomized to either receive early surgery or prolonged conservative treatment for 6 months (followed by surgery if needed). The results indicated that for both groups, similar outcomes were observed at the one year follow up period. However it is important to note that those in the early surgery group demonstrated faster rate of pain relief and perceived recovery, and thus may render this treatment method a valid and supported option.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
The Netherlands Organisation for Health Research and Development (ZonMW) and the Hoelen Foundation, The Hague.
Conflicts:
None disclosed

Risk of Bias

5.5/10

Reporting Criteria

17/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Sciatica resulting from a herniated disc causes radiating pain down the leg. In Western countries, the incidence of sciatica per year is about 5/1000 adults, and this disorder has a large effect on the economy. With regards to cost of hospital care, disorders of the lumbar spine are in the top 5 of disease categories, and also cause increased lost work time and disability. It is widely accepted that surgery should only be performed if conservative treatment has not been successful in reducing symptoms. However, the optimal length of conservative treatment required before surgery is unknown.

What was the principal research question?

In patients presenting with severe sciatica, is earlier surgery more effective in improving outcomes than prolonged conservative treatment, measured over a one year period?

Study Characteristics -
Population:
283 patients with disk herniation and a lumbosacral radicular syndrome. The symptomatic disk herniation was removed via a minimal unilateral transflaval approach with magnification in all patients, with the goal of decompressing the nerve root and reducing the risk of recurrent herniation.
Intervention:
Early surgery Group: Patients allocated to the early group were administered microdiskectomy after a mean of 2.2 weeks (n=141, 3 lost to follow-up; Mean Age: 41.7 SD 9.9; M/F= 89/52).
Comparison:
Prolonged conservative treatment Group: Patients receiving extended conservative treatment were administered surgical fixation after 6 months at mean of 18.7 weeks. (n=142, 2 lost to follow-up; Mean Age: 43.4 SD 9.6; M/F=97/45).
Outcomes:
Functional disability was assessed using the Roland Disability Questionnaire for Sciatica, leg pain was measured using Visual Analogue Scale, and the Likert self-rating scale was used to assess global perceived recovery.
Methods:
Randomized trial; Multiple Centres
Time:
Primary outcomes above measured at 2, 4, 8, 12, 26, 38, and at the 52 week final follow up period.

What were the important findings?

  • Over the 52 week follow up period, there were no significant differences between both groups with respect to the Roland Disability Questionnaire (p=0.13).
  • Those who underwent early surgery had a significant decrease in leg pain compared to the prolonged conservative treatment group (p<0.001).
  • During the first 36 weeks, a faster rate of perceived recovery was observed in the early surgery group (hazard ratio 1.97, 95% CI 1.72 to 2.22, p<0.001).
  • After 52 weeks, both groups had similar recovery rates of 95%.

What should I remember most?

At the one year period, both the group undergoing early surgery, and those receiving conservative treatment reported similar outcomes. However, perceived recovery and pain relief were faster for those patients who underwent early surgery.

How will this affect the care of my patients?

Although both patients treated with early surgery and those who received conservative treatment (and eventual surgery if required) produced similar outcomes at one year, early surgery may be a viable option if patients cannot cope with the leg pain, want to reduce recovery time or do not wish to wait for natural recovery to occur. On the other hand, individuals whose pain is tolerable have the option to defer surgery until absolutely necessary. Further high-quality evidence is required to substantiate these findings.

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