Skip to main content
. 2016 Nov 1;2016(11):CD012421. doi: 10.1002/14651858.CD012421

Stromqvist 2013.

Methods Multi‐centre RCT
Setting: 3 Swedish spine centres
Country: Sweden
Period: not reported
Participants Number: 100 patients (50/50)
Diagnosis: MRI verified spinal stenosis on 1 or 2 levels in the lumbar spine
Included: symptoms of neurogenic claudication for minimum 6 months elicited by walking and relieved by flexion of the spine or sitting down; age 40 years or more was required; spinal stenosis was allowed to be present at maximum 2 levels and minor spondylolisthesis (Meyerding, grade 1) was accepted
Excluded: Previous spine surgery (except for successful disc surgery); infection or malignant disorder; osteoporosis diagnosed before referral for surgery and subjected to medical treatment; stenosis of the L5–S1‐level due to the small spinous process of S1
Age (years): mean (range) 69 (49‐89)
Interventions Group 1: decompression alone. The decompressive procedures were performed using laminectomy or laminotomies with facet‐joint sparing techniques
Group 2: interspinous process spacer device (X‐Stop)
All operations included open procedures
Follow‐up: 24 months
Outcomes Pain: 100 mm VAS leg pain
Disability: ZCQ (physical function)
Operation time
Complications
Reoperations
Notes Surgeon's experience: not reported
Funding: "no funds were received in support of this work"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomization was performed by using envelopes."
Allocation concealment (selection bias) Unclear risk Quote: "randomization was performed by using envelopes."
Blinding of participants (performance bias) 
 All outcomes Unclear risk No mention of any attempts to blind the participants.
Bliding of personnel/ care providers (performance bias) High risk The surgeon could not have been blinded to the intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No mention of any attempts to blind the assessors.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 96/100 = 96% of the patients completed the follow‐up. The number of drop‐outs is unlikely to affect the results.
Intention‐to‐treat analysis (attrition bias) Low risk Quote: "in the main evaluation, not only was intention‐to‐treat analysis used, but also as‐treated analysis was performed."
Selective reporting (reporting bias) Low risk All expected outcomes were reported.
Group similarity at baseline (selection bias) Low risk Patients did not differ in their baseline characteristics, based on Table 1.
Co‐interventions (performance bias) Low risk Only the surgical technique differed between treatment groups.
Compliance (performance bias) Low risk Compliance in both treatment groups: 100% (surgery).
Timing of outcome assessment (detection bias) Low risk All important outcome assessments for both groups were measured at the same time.
Other bias Low risk Quote: "no funds were received in support of this work."