Tough 2010

Methods	RCT pilot/feasibility study Number analysed/randomised: 34/41 Intention‐to‐treat: calculated but not reported Power analysis: reported Funding source: NR
Participants	WAD myofascial pain (injury of 2 to 16 week duration) Participant recruitment: Derriford Hospital Physiotherapy Department, UK
Interventions	INDEX TREATMENT Acupuncture group Trigger point needling using 0.25 mm × 30 to 40 mm length, 6 to 7 sparrow pecking into each MTrP (muscles treated not described) COMPARISON Sham acupuncture Same procedure as treatment group; however, a sham needle 0.30 mm × 50 mm cut, and blunted end was tapped against the skin, with sparrow pecking motion CO‐INTERVENTION Participant education, heat, analgesics and exercise (home therapy) Treatment schedule: 1 session/wk, total 2 to 6 treatments depending on participant response Duration of follow‐up: 6 weeks
Outcomes	PAIN INTENSITY (SF‐McGill Pain Questionnaire, VAS component 10 cm scale) Baseline mean: acupuncture 4.9, sham acupuncture 5.0 End of study mean: acupuncture 1.7, sham acupuncture 3.2 Absolute benefit: acupuncture 3.2, sham acupuncture 1.8 Reported results: not significant SMD ‐0.60 (95% CI random ‐1.29 to 0.09) at 6 weeks DISABILITY: NECK DISABILITY INDEX (NDI 0 to 50 point scale) Baseline mean: acupuncture 18.6, sham acupuncture 20.5 End of study mean: acupuncture 8.4, sham acupuncture 11.9 Absolute benefit: acupuncture 10.2, sham acupuncture 8.6 Reported results: not significant SMD ‐0.41 (95% CI random ‐1.09 to 0.27) at 6 weeks Reasons for drop‐out: increased pain (stopped attending: 3 acupuncture, 4 sham) Adverse effects: increased pain (16/20 acupuncture, 9/20 sham) Costs of care: NR
Notes	‐‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Reported as random allocation sequence, computer‐generated using block size of 4
Allocation concealment (selection bias)	Low risk	Held centrally by the pharmacy department at the research site; allocation concealed from the investigator until after participant enrolment
Blinding (performance bias and detection bias) All outcomes ‐ patient?	Unclear risk	Unclear whether sham was indistinguishable
Blinding (performance bias and detection bias) All outcomes ‐ care provider?	High risk	Not possible because of design
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor?	Unclear risk	Participant was the outcome assessor with self reports
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable?	Low risk	Acceptable at 17%
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated?	High risk	Only participants who completed the study were included; ITT done only for P value
Selective reporting (reporting bias)	Unclear risk	No protocol available
Similarity of baseline characteristics	Low risk	Reported as similar Tables 1 and 2
Co‐interventions avoided or similar?	Unclear risk	Not reported
Compliance acceptable?	Unclear risk	Exercise booklet given; unsure whether participants received all acupuncture treatment prescribed
Similar timing of outcome assessment?	Low risk	Baseline, 3 and 6 weeks
Fatal Flaw	Low risk	Acceptable