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. 2015 Sep 23;2015(9):CD004249. doi: 10.1002/14651858.CD004249.pub4

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
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
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