Ljunggren 1997.
| Methods | Randomised, concealed allocation, and intention‐to‐treat basis. No control and blinding. | |
| Participants | The study was conducted at four physiotherapy centres in southern Norway. Participants were selected after ordinary physio treatment for LBP. Inclusion criteria: both genders, age 18 to 65 years, and history of back problems. Exclusion criteria: participants for whom any of exercises were contraindicated. Total of 153 participants were included and 126 completed. The analysis is based on 126 participants. Terapimaster group, N = 62; Conventional Training group, N = 64; 70 men and 56 women, mean age 40 years in Conventional exercise group and 39 years in TerapiMaster exercise group. |
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| Interventions | Post‐ treatment TerapiMaster programme group: Subjects underwent an exercise programme for one year, which consisted of 9 back, abdominal and whole body strengthening exercises by TerapiMaster device in 3 sets of 10 repetitions for 15 to 30 minutes each session, 3 sessions a week at home. Progression in the programme, decided in cooperation with the physiotherapist, was done by adding extra weights. Conventional exercise programme: Subjects underwent a conventional exercise programme for one year, without TerapiMaster device at home. The exercise programme was consisted of 9 back, abdominal and whole body strengthening exercises in 3 sets of 10 repetitions for 15 to 30 minutes each session, 3 sessions a week. |
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| Outcomes | Days of sick leaves due to LBP. | |
| Notes | There was no mentioning of the initial numbers of participants randomised into Intervention group and a control group. Dropout rate is 17.6%. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | |
| Allocation concealment? | Low risk | Adequate. |
| Blinding? All outcomes | High risk | Patients and providers not blinded; outcome assessment was by self‐report. |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | |
| Similarity of baseline characteristics? | High risk | Fewer men in the intervention group. |
| Co‐interventions avoided or similar? | Unclear risk | No information provided on regular medical treatment. |
| Compliance acceptable? | Low risk | |
| Timing of outcome assessments similar? | Low risk | |