Methods | Blinding: no blinding Dropouts/withdrawals: no dropouts until treatment completion, 11 patients with missing data at 3 months follow-up and 34 at 6 months could not be analyzed (main reasons lacking headache diaries) Observation period: 4 weeks baseline; 2.5 to 3 months treatment; 7 months follow-up Acupuncturists’ assessments: GA differently/65% - BB differently/50% |
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Participants | Number of patients included/analyzed: 90/90 Condition: chronic tension-type headache (IHS) Demographics: mean age 37.5 years, 81% female Setting: 3 physiotherapy clinics in Sweden Time since onset of headaches: median duration 7.5 years |
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Interventions | Acupuncture points: mandatory GB20, GB14, LI4, ST44, optional PC6, PC7, SP6, BG34, ST8, EX1 and EX2 Information on acupuncturists: 5 experienced physiotherapists DeChi achieved?: yes Number of treatment sessions: 12 Frequency of treatment sessions: 1/week Control intervention 1: physical training (10 sessions at the clinic + 15 home training sessions; exercises focusing on neck and shoulder muscles) Control intervention 2: relaxation (progressive muscle relaxation and autogenic relaxation techniques, breathing, stress coping) |
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Outcomes | Method for outcome measurement: diary, pain rating Outcomes: headache intensity, headache-free days, headache-free periods |
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Notes | Some additional information received from first author | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Sealed opaque envelopes were prepared and mixed in a box. After inclusion of a patient, an envelope was taken from the box. |
Allocation concealment? | Unclear | See above |
Blinding? All outcomes |
No | No blinding |
Incomplete outcome data addressed? All outcomes |
Yes | Low attrition arte and intention-to-treat analysis |
Free of selective reporting? | Yes | Relevant outcomes reported |
Incomplete follow-up outcome data addressed? | Unclear | More than a third of patients were lost to follow-up (dropout rates similar in all three groups and intention-to-treat analysis) |