| Methods |
Design: 2x2 factorial design with an additional randomisation for one arm
Purpose: examine the effect of a home based exercise programme on knee pain, and to determine the contribution of the contact with a therapist in explaining the outcome |
| Participants |
Patients: out‐patients with knee pain recruited through a postal questionnaire
Baseline comparability: yes (age, gender, pain, weight, etc) |
| Interventions |
Placebo: tablet with dolomite (calcium and magnesium) twice weekly for two years
Untreated: no tablets
Experimental:
‐exercise (20‐30 minutes daily, initiated by four 30 minutes' instruction sessions within the first two months in the patients' home, and follow up visits every six months).
‐telephone (monthly telephone contact)
(Co‐intervention: no information on use of analgesic drugs) |
| Outcomes |
Pain (WOMAC osteoarthritis index, 0 to 20)
Knee stiffness
Disability
General physical function (SF‐36)
Hospital anxiety and depression scale
Isometric quadriceps muscle strength |
| Notes |
Not 1:1 randomisation. Dropout rate: 23.7%. Results not presented for placebo and no‐treatment, but authors provided additional data. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'computer generated lists in permuted blocks of 10, stratified by sex and age' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (home based exercise/placebo) |
| Blinding?
Outcome assessor |
Unclear risk |
Patient reported outcome (interviewer was blinded) |
| Incomplete outcome data addressed?
All outcomes |
High risk |
|
| Free of selective reporting? |
High risk |
No protocol available. Results not presented for placebo and no‐treatment, but authors provided additional data. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 156 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
|
