Ebadi 2012.
| Study characteristics | ||
| Methods | RCT conducted in outpatient department (secondary care setting) | |
| Participants | 50 patients aged between 18 and 60 years with non‐specific chronic low back pain were randomised. Exclusion criteria were: nerve root symptoms; systemic disease and specific conditions such as neoplasm, fractures, spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis; previous low back surgery; taking medication for specific psychological problems; and pregnancy. Participants were recruited from 3 university hospitals in Tehran, Iran. | |
| Interventions | The intervention (I) group (n = 24) received continuous ultrasound plus semi‐supervised exercise. Continuous ultrasound with a frequency of 1 MHz and an intensity of 1.5 W/cm² was applied to the painful paravertebral low back region. The duration of US was estimated for each participant using the formula: total treatment time = planned average local exposure time x (tissue area/effective radiation area of applicator). The (C) control group (n = 24) received placebo ultrasound plus semi‐supervised exercise. Placebo ultrasound involved the machine being turned on, with lights visible to the participant, but no current being applied. All participants in both groups received 10 sessions of treatment, 3 times a week, every other day. |
|
| Outcomes | 48 participants completed treatment sessions. Mean (SD) pre‐ and post‐treatment scores for VAS were: (I) 46.6 (17.7), 26.6 (13.8); and (C) 49 (16), 30.7 (13.1). Mean (SD) pre‐ and post‐treatment scores for Functional Rating Index were: (I) 40.8 (14.6), 23.4 (6.9); and (C) 43.9 (16.9), 31.1 (13.4). Changes in lumbar range of motion, muscle endurance, and median frequency slope of all measured paravertebral muscles were not significantly different between groups. | |
| Notes | No conflict of interest declared with regard to commercial funding. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule |
| Allocation concealment (selection bias) | Low risk | Allocation was performed using opaque, sealed envelopes. |
| 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 measure is self‐reported, participants blinded to group allocation. |
| Incomplete outcome data (attrition bias) Dropout rate described | Low risk | Described and acceptable |
| Incomplete outcome data (attrition bias) Intention‐to‐treat | Low risk | All randomised participants included in analysis. |
| Selective reporting (reporting bias) | Low risk | Trial was pre‐registered and published protocol was available. All outcomes reported. |
| Similar groups | Low risk | Groups were well matched at baseline. |
| Co‐interventions | Low risk | Participants advised not to commence new treatments. |
| Compliance | Unclear risk | Not reported in text |
| Timing of outcome measures | Low risk | Similar timing of outcome assessment (post‐treatment) for both groups |