Durmus 2010a.
| Study characteristics | ||
| Methods | RCT conducted in unknown setting (not reported) | |
| Participants | 42 patients (29 females and 13 males) with chronic LBP lasting for at least 3 months were included in the study. Patients were excluded from the study for the following reasons: evidence of acute radiculopathy; the presence of an inflammatory disease, neoplastic disease, spondylolysis, spondylolisthesis, or sacroiliitis; lumbar disc herniation requiring surgical treatment; vertebral fractures; pregnancy. | |
| Interventions | Intervention (I) group (n = 21) participants received hot packs (15 minutes), ultrasound, and exercise. In this group, 1 MHz continuous ultrasound was applied to the lumbar paravertebral region at an intensity of 1 W/cm² for 10 minutes using a probe with an effective radiating area of 5 cm². Control (C) group (n = 21) participants received hot packs (15 minutes), placebo ultrasound, and exercise. Placebo ultrasound was applied to the same region for the same duration, with the same ultrasound device. No current was applied, but the device and the indicator lights were kept in the 'on' position. Both groups performed range of motion, stretching (hamstring, pelvic, and abdominal muscles), and strengthening (cervical, thoracic, and lumbar region muscles) exercises for 15 minutes. Participants were treated 5 days a week for 3 weeks. |
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| Outcomes | Median (range) scores on the modified Oswestry Low Back Pain Disability Questionnaire pre‐ and post‐treatment were: (I) 38 (26 to 76), 12 (1 to 32); and (C) 44 (22 to 50), 17 (6 to 23). Median (range) scores on the VAS at rest pre‐ and post‐treatment were: (I) 6 (3 to 10), 2 (1 to 5); and (C) 6 (3 to 9), 4 (1 to 9). Significantly greater improvement was observed in (I) compared to (C) in Pain Disability Index scores, 6‐minute walk test, emotional and physical role functioning (SF‐36), functional performance, and depression. |
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| Notes | Attempts made to contact authors for further data (as all data were reported as median (range)) were met with no response. No conflict of interest declared with regard to commercial funding. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method for determining randomisation sequence not reported in text. |
| Allocation concealment (selection bias) | Unclear risk | Not reported in text |
| Blinding of participants and personnel (performance bias) Participants | Low risk | Participants blinded to group allocation. |
| Blinding of participants and personnel (performance bias) Care providers | High risk | Care providers not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Primary outcome measures are self‐reported, participants blind to group allocation. |
| Incomplete outcome data (attrition bias) Dropout rate described | Low risk | No dropouts reported. |
| Incomplete outcome data (attrition bias) Intention‐to‐treat | Low risk | No dropouts reported, presumed complete outcome data were available. |
| Selective reporting (reporting bias) | Unclear risk | No trial pre‐registration or published protocol was available. |
| Similar groups | Low risk | Groups were well matched at baseline. |
| Co‐interventions | Unclear risk | Not reported in text |
| Compliance | Unclear risk | Not reported in text |
| Timing of outcome measures | Low risk | Similar timing of outcome assessment (post‐treatment) for both groups |