Katz 2011.
| Methods | RCT, double‐blind | |
| Participants | 217 participants, 118 women, 99 men Inclusion: participants aged ≥ 18 years, body mass index ≤ 39 kg/m², nonradiculopathic low back pain for at least 3 months, required regular analgesic medication, analgesic medication > 4 days/week over the previous month, average pain intensity score ≥ 4 over previous 24 hours on 11‐point numerical rating scale, minimum compliance of 4 entries in electronic daily pain diary over the 5 previous days Exclusion: radiculopathy in previous 2 years, secondary causes of back pain, surgical intervention for treatment of back pain, pregnancy, lactation, rheumatoid arthritis, seronegative spondyloarthropathy, Paget disease of spine, pelvis or femur, fibromyalgia, tumours or infections of spinal cord, cancer in previous 2 years other than cutaneous basal cell or squamous cell carcinoma, allergic reaction to monoclonal antibody or IgG‐fusion protein, acetaminophen or NSAIDs, contraindications to NSAID therapy |
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| Interventions | NSAID (i): naproxen 1000 mg daily and placebo single intravenous infusion, 12 weeks (N = 88) Reference treatment (ii): tanezumab single intravenous infusion 200 μg/kg and oral placebo daily, 12 weeks (N = 88) Reference treatment (iii): placebo single intravenous infusion and oral placebo daily, 12 weeks (N = 41) |
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| Outcomes | Mean change in average low back pain intensity over previous 24 hours on 11‐point numerical rating scale, at 6 weeks compared to baseline: (i versus iii) ‐2.5 versus ‐2.0 (P = 0.068) Adverse events: (i) 54 participants (3 withdrew); (ii) 50 participants (4 withdrew); (iii) 27 participants (2 withdrew) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding (performance bias and detection bias): All outcomes ‐ Patients All outcomes | Low risk | Patients were blinded, placebo tablets/injections |
| Blinding (performance bias and detection bias): All outcomes ‐ Care providers All outcomes | Unclear risk | Unclear if care providers were blinded |
| Blinding (performance bias and detection bias): All outcomes ‐ Outcome assessors All outcomes | Low risk | Outcome assessors were blinded |
| Incomplete outcome data (attrition bias): All outcomes ‐ Drop‐outs All outcomes | High risk | Drop out 32% |
| Incomplete outcome data (attrition bias): All outcomes ‐ ITT analysis All outcomes | Low risk | ITT was performed |
| Selective reporting (reporting bias) | Low risk | Trial was registered |
| Similarity of baseline characteristics | Low risk | Baseline characteristics were similar |
| Co‐interventions avoided or similar | Low risk | Rescue medication acetaminophen with a maximum of 2000 mg per day and maximum 3 days per week |
| Compliance acceptable | Low risk | Nine people discontinued the trial |
| Timing outcome assessments similar | Low risk | Timing similar |