| Methods |
Design: three group parallel trial
Purpose: examine the effect of skin temperature biofeedback on Raynaud's disease |
| Participants |
Patients: out‐patients with primary Raynaud's disease
Baseline comparability: yes (age and severity of attack) |
| Interventions |
Placebo: biofeedback training focused at relaxing forehead muscles
Untreated: no training
Experimental: biofeedback training focused at increasing finger temperature
(Co‐intervention: no ) |
| Outcomes |
Number of patients with attacks
Duration of attacks
Severity of attacks
Extent of hand involvement
Number of symptoms experienced
Pain
Impairment
Length of time spent in laboratory to relieve the attack
Amount of relief obtained from laboratory training |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'... a double‐blind design was adopted' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| 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? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 24 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
