Hurwitz 2002.
Methods | Type of trial: RCT (2 × 2 × 2 factorial design) Number analysed/randomly assigned: 269/336 Intention‐to‐treat analysis: done by design | |
Participants | Subacute chronic neck pain with or without radicular symptoms and headache | |
Interventions | INDEX TREATMENTS
Manipulation (Manip): technique: controlled, dynamic thrust applied with high‐velocity low‐amplitude force with minimal extension and rotation; frequency: NR; dose: at least 1 manipulation; route: directed at 1 or more restricted upper thoracic or cervical spine joint segments Manipulation with heat (Manip + H): 10‐minute moist heat application before manipulation Manipulation with EMS (Manip + EMS): 10‐minute application of this modality before manipulation; parameters NR Mobilisation (Mob): technique: low‐velocity variable‐amplitude movements applied within the individual's passive range of motion directed to 1 or more restricted upper thoracic or cervical spine joint segments; frequency: NR; route: cervical spine and thoracic spine Mobilisation with heat (Mob + H): 10‐minute moist heat application before mobilisation Mobilisation with EMS (Mob + EMS): 10‐minute application of this modality before mobilisation; parameters NR COMPARISON TREATMENTS Any of the above noted treatment combinations CO‐INTERVENTION: All participants received information on posture and body mechanics and 1 or more of the following ‐ stretching, flexibility or strengthening exercises ‐ and advice about ergonomic and workplace modifications. Duration of treatment: NR Duration of follow‐up: 6 months |
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Outcomes | PAIN INTENSITY (average pain during previous week, most severe pain, NRS, 0 to 10)
Baseline mean: NR for each subgroup
End of study mean: NR for each subgroup
Reported results: no significant differences, heat therapies: condition improved slightly more, and differences were clinically negligible (=?). Significant favouring the combination of manipulation, electrical stimulation and heat over mobilisation, electrical stimulation and heat
SMD (Manip vs Mob): 0.15 (95% CI: ‐0.32 to 0.61) SMD (Manip + EMS vs Mob + EMS): 0.32 (95% CI ‐0.16 to 0.8) SMD (Manip + EMS + H vs Mob + EMS + H): ‐0.62 (95% CI ‐1.12 to ‐0.11) SMD (Manip + H vs Mob + H): ‐0.17 (95% CI ‐0.64 to 0.31) RR (heat vs no heat): 1.14 (95% CI mixed: 0.95 to 1.37) RR (EMS vs no EMS): 0.90 (95% CI mixed: 0.73 to 1.13) FUNCTION (NDI, 0 to 50) Baseline mean: NR for each subgroup End of study mean: NR for each subgroup Reported results: no significant difference SMD (Manip vs Mob): 0.07 (95% CI ‐0.40 to 0.54) (power 66%) SMD (Manip + EMS + H vs Mob + EMS + H): ‐0.28 (95% CI ‐0.77 to 0.22) SMD (Manip + EMS vs Mob + EMS): 0.37 (95% CI ‐0.10 to 0.85) SMD (Manip + H vs Mob + H): ‐0.18 (95% CI ‐0.66 to 0.29) RR (heat vs no heat): 1.14 (95% CI mixed: 0.94 to 1.38) RR (EMS vs no EMS): 0.87 (95% CI mixed: 0.69 to 1.10) SATISFACTION (10 to 50 scale; at 4w of care) SMD (Manip vs Mob): 0.11 (95% CI ‐0.34 to 0.57) SMD (Manip + EMS + H vs Mob + EMS + H): 0.14 (95% CI ‐0.31 to 0.59) SMD (Manip + EMS vs Mob + EMS): 0.11 (95% CI ‐0.35 to 0.56) SMD (Manip + H vs Mob + H): ‐0.28 (95% CI ‐0.72 to 0.17) GPE: NR QoL: NR PATIENT SATISFACTION: NR SIDE EFFECTS: interviewed at 4 weeks of care, no known study‐related adverse events; manipulation group had statistically significant more transient minor discomfort (16%) vs mobilisation group (8.7%) COST OF CARE: number of disability days not significantly different between groups |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Page 1634, middle column, paragraph 2 |
Allocation concealment (selection bias) | Low risk | Page 1634, middle column, paragraph 2 |
Blinding of Participants (performance bias) | High risk | Not possible owing to differences in treatment methods |
Blinding of Personal (performance bias) | High risk | Not possible |
Blinding of the Outcome assessor (detection bias) | High risk | Subjective rating of pain |
Incomplete outcome data (attrition bias) | Low risk | Page 1636, paragraph 2 |
Randomized Participants analysed were allocated (attrition bias) | Unclear risk | Intention‐to‐treat not described |
Selective outcome (reporting bias) | Unclear risk | Not described |
Similar groups at baseline? | Low risk | Table 1 |
co‐interventions avoided or similar? | Unclear risk | Not described |
Compliance acceptable? | Unclear risk | Not described |
Similar timing of outcome assessment? | Low risk | Baseline, 2 weeks, 6 weeks, 3 months, 6 months |