Gonzalez‐Iglesias 2009 JO.
| Methods | Type of trial: RCT
Number analysed/randomly assigned: 45/45
Intention‐to‐treat analysis: NA Protocol: The protocol for this study was approved by the Human Research Committee of the Escuela de Osteopatía de Madrid |
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| Participants | Acute neck pain | |
| Interventions | INDEX TREATMENT
Thoracic spine thrust manipulation (TSM): technique: seated distraction manipulation ‐ participant had arms across chest, therapist gently flexed the thoracic spine until tension was felt, and then a distraction thrust manipulation was applied. If no pop was heard, a second attempt was made; frequency: 1 session/wk; dose: grade 5 manipulation; route: thoracic spine Electrothermal therapy (ETT): type: infrared lamp and TENS; frequency: 2 sessions/wk; dose: infrared 250 W for 15 minutes, TENS 100 Hz for 20 minutes; route: infrared lamp 50 cm from the participant's neck, TENS applied to each side of C7 COMPARISON TREATMENT Electrothermal therapy (ETT): type: infrared lamp and TENS; frequency: 2 sessions/wk; dose: infrared 250 W for 15 minutes, TENS 100 Hz for 20 minutes; route: infrared lamp 50 cm from the participant's neck, TENS applied to each side of C7 CO‐INTERVENTION: NR Duration of treatment: 3 weeks, 5 sessions Duration of follow‐up: 4 weeks |
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| Outcomes | PAIN (intensity at rest change score, VAS, 0 to 100) Baseline mean: TSM + ETT 54.7, ETT 52.7 IP treatment mean: TSM + ETT 20.2, ETT 44.7 2‐Week follow‐up mean: TSM + ETT 26.4, ETT 41.2 4‐Week follow‐up mean: TSM + ETT 21.5, ETT 42.2 Reported results: significant for comparisons at all time points IP treatment SMD (TSM + ETT vs ETT): ‐3.43 (95% CI ‐4.38 to ‐2.49) 4‐Week follow‐up SMD (TSM + ETT vs ETT): ‐2.19 (95% CI‐2.94 to ‐1.44); NNTB 7 FUNCTION (Northwich Park Pain Questionnaire, 0 to 36) Baseline mean: TSM + ETT 27.9, ETT 27.0 IP treatment mean: TSM + ETT 15.2, ETT 23.1 2‐Week follow‐up mean: TSM + ETT 14.7, ETT 21.8 Reported results: significant for comparisons at all time points IP treatment SMD (TSM + ETT vs ETT): ‐2.17 (95% CI ‐2.92 to ‐1.42) 2‐Week follow‐up SMD (TSM + ETT vs ETT): ‐2.28 (95% CI ‐3.05 to ‐1.52); NNTB 5 4‐Week follow‐up: not collected GPE: NR PATIENT SATISFACTION: NR QoL: NR SIDE EFFECTS: NR COST OF CARE: NR |
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| Notes | For 4‐week disability (NPPQ) data: "We only collected changes in disability up to the 2‐week follow‐up period. It would have been beneficial to see if these benefits remain at 1‐month, similar to the improvements in pain" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Page 21, column 3, paragraph 3 |
| Allocation concealment (selection bias) | Low risk | Page 21, column 3, paragraph 3 |
| Blinding of Participants (performance bias) | High risk | Participants in control did not receive sham or placebo |
| Blinding of Personal (performance bias) | High risk | Not possible owing to intervention |
| Blinding of the Outcome assessor (detection bias) | High risk | Not possible as participant was assessor of pain |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts |
| Randomized Participants analysed were allocated (attrition bias) | Low risk | No dropouts |
| Selective outcome (reporting bias) | Unclear risk | No reported protocol |
| Similar groups at baseline? | Low risk | |
| co‐interventions avoided or similar? | Unclear risk | Not mentioned |
| Compliance acceptable? | Unclear risk | Not mentioned |
| Similar timing of outcome assessment? | Low risk | |