Sloop 1982.
| Methods | Type of trial: RCT cross‐over design Number analysed/randomly assigned: 39/39 Intention‐to‐treat analysis: calculated | |
| Participants | Subacute chronic neck pain with variable degenerative changes (cervical spondylosis) | |
| Interventions | INDEX TREATMENT
Manipulation group (manip): technique: manipulation described by Cyriax, Maigne, Maitland, Matthews, muscle relaxant; frequency: 1 session; route: cervical spine COMPARISON TREATMENT Control treatment (cntl): muscle relaxant CO‐INTERVENTION: "other medical management was not restricted during the study" Duration of treatment: 1 session Duration of follow‐up: 3 weeks (then cross‐over occurs) |
|
| Outcomes | PAIN (neck pain intensity; VAS, 0 to 100)
Baseline: NR
Absolute benefit: manip 18, cntl 5
Reported results: not significant
SMD: 0.40 (95% CI ‐1.04 to 0.23) (power 5%) FUNCTION (selected daily activities; VAS, 0 to 100) Baseline: NR Reported results: not significant PATIENT SATISFACTION: NR QoL: NR GPE [patient perceived effect, 0 (completely well) to 8 (worst possible), collapsed to dichotomous response (improved/not improved) Reported results: not significant RR: 0.59 (95% CI 0.34 to 1.05) SIDE EFFECTS: 2 people had superficial phlebitis following diazepam injection and recovered uneventfully; 2 people in the manipulation group reported new discomfort in their neck followed by improvement in their chronic neck pain RR: 1.0 (95% CI 0.4 to 2.4) COST OF CARE: NR |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Page 533, column 1, paragraph 1 |
| Allocation concealment (selection bias) | Low risk | Page 533, column 2, paragraph 2 |
| Blinding of Participants (performance bias) | Low risk | Cross‐over design |
| Blinding of Personal (performance bias) | High risk | Not possible owing to design |
| Blinding of the Outcome assessor (detection bias) | Low risk | Page 533, column 2, paragraph 3 |
| Incomplete outcome data (attrition bias) | Low risk | Page 534, column 1, paragraph 1 |
| Randomized Participants analysed were allocated (attrition bias) | Low risk | Cross‐over design |
| Selective outcome (reporting bias) | Unclear risk | No reported protocol |
| Similar groups at baseline? | Low risk | Page 533, column 1, paragraph 5 |
| co‐interventions avoided or similar? | High risk | Not reported |
| Compliance acceptable? | Low risk | Cross‐over design |
| Similar timing of outcome assessment? | Low risk | Baseline, 3 weeks, 12 weeks |