Escortell‐Mayor 2011.
| Methods | Type of trial: RCT Number analysed/randomly assigned: 71/90 Intention‐to‐treat analysis: calculated | |
| Participants | Chronic non‐specific cervical disorder | |
| Interventions | INDEX TREATMENT
Manual therapy (A): technique: neuromuscular technique, post‐isometric, stretching, spray and stretching (Jones technique); timing: at baseline; frequency: 10 treatments on alternate days; duration: 30 minutes COMPARISON TREATMENT TENS (B): technique: TENS electrodes were placed in painful area, in the metamere or in the pathway of the nerve; timing: at baseline; frequency: 10 treatments; dose: 80 Hz at ≤ 150 μs; duration: 30 minutes CO‐INTERVENTION: not avoided: medication; avoided in trial design: other health professionals Duration of treatment: 1 month, 10 sessions Duration of follow‐up: 6 months, not specified for participant satisfaction |
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| Outcomes | PAIN (VAS, 0 to 100 mm) Baseline mean: A 54.91, B 56.45 End of study mean: A 33.01, B 35.12 Absolute benefit: A 21.90, B 21.33 Reported results: not significant SMD (A vs B): IP ‐0.10 (95% CI ‐0.52 to 0.32), IT ‐0.12 (95% CI ‐0.59 to 0.34) FUNCTION (NDI, 0 to 50) Baseline mean: A 31.63, B 34.38 End of the study mean: A 22.23, B 23.90 Absolute benefit: A 9.40, B 10.48 Reported results: not significant SMD (A vs B): IP ‐0.12 (95% CI ‐0.54 to 0.30), IT 0.07 (95% CI ‐0.40 to 0.53) PATIENT SATISFACTION (Likert scale, 1 to 7) End of the study mean: unsatisfied: A 2, B 3, indifferent: A 0, B 2, satisfied: A 45, B 37 Reported results: not significant RR (A vs B): 1.09 (95% CI 0.96 to 1.23) GPE: NR QoL (PCS component of the SF‐12, 0 to 100) Baseline mean: A 43.26, B 42.66 End of the study mean: A 45.56, B 47.42 Absolute benefit: A 2.30, B 4.76 Reported results: not significant SMD (A vs B): IP ‐0.20 (95% CI ‐0.63 to 0.23), IT 0.22 (95% CI ‐0.25 to 0.68) SIDE EFFECTS: NR COST OF CARE: NR |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of block randomisation is not clearly stated; it is not clear whether complete blocks were done at each centre |
| Allocation concealment (selection bias) | Unclear risk | Envelopes were not numbered |
| Blinding of Participants (performance bias) | High risk | Not possible owing to design |
| Blinding of Personal (performance bias) | High risk | Not possible owing to design |
| Blinding of the Outcome assessor (detection bias) | High risk | Not possible owing to design |
| Incomplete outcome data (attrition bias) | Low risk | Figure 1 |
| Randomized Participants analysed were allocated (attrition bias) | Low risk | Page 69, paragraph 2 |
| Selective outcome (reporting bias) | Unclear risk | No protocol |
| Similar groups at baseline? | Low risk | Table 1 |
| co‐interventions avoided or similar? | Unclear risk | Not reported |
| Compliance acceptable? | Unclear risk | Home exercise compliance not reported |
| Similar timing of outcome assessment? | Low risk | Baseline, 1 month, 6 months |