Bitterli 1977.
| Methods | Type of trial: quasi‐RCT Number analysed/randomly assigned: 24/30 Intention‐to‐treat analysis: calculated | |
| Participants | Chronic neck pain with headache or degenerative changes (spondylogenic) | |
| Interventions | INDEX TREATMENT
Group A (A): technique: manipulation as described by Maigne; frequency: 1 session/wk; dose: mean 6.2 manipulations over 3.2 sessions; route: cervical spine Group B (B): technique: manipulation; frequency: 1 session/wk; dose: mean 7.2 manipulations over 3.8 sessions; route: cervical spine COMPARISON TREATMENT Group C (C): wait list control CO‐INTERVENTION: none Duration of treatment: 3 weeks, 3 to 4 sessions Duration of follow‐up: 12 weeks |
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| Outcomes | PAIN (VAS, 0 to 100) Baseline mean: A 60.50, B 64.40, C 57.60 End of study mean: A 38.50, B 27.80, C 43.50 Absolute benefit: A 22.0, B 36.6, C 14.1 Reported results: not significant SMD (A vs C): ‐0.18 (95% CI‐1.12 to 0.75) (power 10%) SMD (A vs B): 0.36 (95% CI‐0.58 to 1.30) (power 7%) SMD (B vs C): ‐0.54 (95% CI‐1.43 to 0.36) (power 10%) FUNCTION: NR GPE: NR PATIENT SATISFACTION: NR QoL: NR SIDE EFFECTS: Manipulation and mobilisation were well tolerated, with the customary reaction of minimal benign reaction lasting less than 24 hours (RR 1.34, 95% CI 0.77 to 2.34) COST OF CARE: NR |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Draw lots; even chance of getting assigned to 1 of 3 groups |
| Allocation concealment (selection bias) | High risk | Not concealed |
| Blinding of Participants (performance bias) | High risk | VAS pain; not blind to participant |
| Blinding of Personal (performance bias) | High risk | Not blind |
| Blinding of the Outcome assessor (detection bias) | High risk | Participant is outcome assessor for VAS pain |
| Incomplete outcome data (attrition bias) | Low risk | See Table 1, page 260, for complete data |
| Randomized Participants analysed were allocated (attrition bias) | High risk | ITT not reported |
| Selective outcome (reporting bias) | Unclear risk | No previous protocol |
| Similar groups at baseline? | Low risk | Presented in text, page 260, 2nd column, 2nd paragraph. |
| co‐interventions avoided or similar? | Low risk | No co‐intervention was noted |
| Compliance acceptable? | High risk | Not assessed |
| Similar timing of outcome assessment? | Low risk | All groups were measured at similar time points |