Methods | RCT Number analysed/randomised: 60/60 Intention‐to‐treat: NR Power analysis: NR Funding source: NR |
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Participants | Chronic myofascial pain syndrome | |
Interventions | INDEX TREATMENT Dry needling (dn) upper trapezius COMPARISON TREATMENT Placebo laser CO‐INTERVENTION Paracetamol as needed Treatment schedule: dn once/wk over 4 weeks, placebo laser 3 sessions/wk over 4 weeks Duration of follow‐up: immediate post treatment and 6 months |
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Outcomes | PAIN INTENSITY (VAS activity 10 cm scale) Baseline mean: dn 7.62, placebo 7.65 End of study mean: dn 4.24, placebo 4.22 Absolute benefit: dn 3.38, placebo 3.43 Reported results: significant differences favouring laser compared with dn and placebo post treatment only SMD ‐0.02 (95% CI random ‐0.64 to 0.60) immediate post treatment SMD 0.01 (95% CI random ‐0.61 to 0.63 at 6 months FUNCTION: Nottingham Health Profile Physical Activity Component (0 to 100) Baseline mean: dn 32.80, placebo 25.59 End of study mean: dn 13.68, placebo 16.08 Absolute benefit: dn 19.12, placebo 9.51 Reported results: significant differences favouring laser compared with dn and placebo SMD 0.22 (95% CI random ‐0.40 to 0.84) immediate post treatment SMD ‐0.14 (95% CI random ‐0.76 to 0.48) at 6 months Adverse effects: NR Costs of care: NR |
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Notes | ‐‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes ‐ patient? | High risk | Interventions perceivably different |
Blinding (performance bias and detection bias) All outcomes ‐ care provider? | High risk | Not possible |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? | High risk | Participant as outcome assessor not blinded |
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable? | High risk | Not described, no n's in tables |
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? | Unclear risk | Not reported |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Similarity of baseline characteristics | Low risk | Reported to be similar |
Co‐interventions avoided or similar? | Unclear risk | Followed medication use only |
Compliance acceptable? | Unclear risk | Not reported |
Similar timing of outcome assessment? | Low risk | All assessed immediately post treatment and at 6 months |
Fatal Flaw | High risk | Unclear randomisation, allocation concealment; drops‐outs not described; unclear whether ITT done |