| Methods |
Design: three group parallel trial
Purpose: study the effect of the Trager approach on chronic headache |
| Participants |
Patients: outpatients with chronic headache
Baseline comparability: yes |
| Interventions |
Placebo: attention treatment by physician including physical exam (15 to 20 minutes)
Untreated: no treatment
Experimental: Trager approach (movement based educational process to increase body awareness, learn relaxation skills, and practise pain‐free, balanced movement)
(Co‐intervention: medication) |
| Outcomes |
The headache quality of life instrument
Headache frequency, duration, and intensity
Medication use |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/Trager) |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 18 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |