Zucherman 2004.
| Methods | Multi‐centre randomised clinical trial | |
| Participants | Nine centres randomly assigned 200 participants between May of 2000 and July of 2001, in a prospective, controlled trial. Of 200 participants enrolled in this study, 191 were treated: 100 in the X STOP group and 91 in the conservative group. Most of the 9 patients from conservative group who withdrew from the study before receiving their initial epidural injection entered the study with the hope of being randomly assigned to the X STOP group Inclusion criteria: ≥ 50 years of age with leg, buttock or groin pain, with or without back pain, that could be relieved during flexion; able to sit for 50 minutes without pain and to walk 50 or more feet; completed ≥ 6 months of non‐operative therapy. Stenosis was confirmed by CT or MRI scans at 1 or 2 levels Primary exclusion criteria: fixed motor deficit, cauda equina syndrome, significant lumbar instability, previous lumbar surgery, significant peripheral neuropathy or acute denervation secondary to radiculopathy, scoliotic Cobb angle > 25°, spondylolisthesis > grade 1.0 (on a scale of 1 to 4) at the affected level, sustained pathological fractures or severe osteoporosis, obesity, active infection or systemic disease, Paget’s disease or metastasis to the vertebrae, steroid use for longer than 1 month within 12 months preceding the start of the study |
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| Interventions | Participants enrolled in the X STOP group underwent surgery for implantation of the interspinous implant. Those randomly assigned to the conservative group received ≥ 1 epidural steroid injection and could receive non‐steroidal anti‐inflammatory drugs, analgesics and physical therapy. Physical therapy consisted of back school and modalities such as ice packs, heat packs, massage, stabilisation exercises and pool therapy. Braces, such as abdominal binders and corsets, were permitted, but body jackets and chair‐back braces were not allowed | |
| Outcomes | Outcomes: SF‐36, Zurich Claudication Questionnaire (ZCQ), Oswestry Disabilty Index, Worker's Compensation Claim, radiographic changes Time points: 6 weeks, 6 months, 1 year |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Block randomisation by surgical centre |
| Allocation concealment (selection bias) | Low risk | After baseline examination and questionnaires were completed, treating physician phoned the central office, gave participant identification data and received treatment allocation |
| Blinding (performance bias and detection bias) All outcomes | High risk | Blinding of participants not possible for the types of interventions compared |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Only data from completers used |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Group similarity at baseline (selection bias) | Low risk | Similar groups at baseline |
| Co‐interventions (performance bias) | High risk | Co‐interventions not standardised and not properly described |
| Compliance (performance bias) | High risk | Compliance not monitored for the control group |
| Intention‐to‐treat‐analysis | Unclear risk | Not described |
| Timing of outcome assessments (detection bias) | Unclear risk | Similar timing for both groups |
| Other bias | Unclear risk | Not clear |
Abbreviations:
ASA: acetylsalicylic acid.
COPD: chronic obstructive pulmonary disease.
CT: computed tomography.
ESI: epidural steroid injections
ITT: intention‐to‐treat.
LSS: lumbar spinal stenosis.
MRI: magnetic resonance imaging.
ODI: Oswestry Disability Index.
SF‐36: Short Form 36.