Ansari 2006.
Study characteristics | ||
Methods | RCT conducted in outpatient physiotherapy clinic (secondary care setting) | |
Participants | 15 participants were randomised, who were aged 18 to 65 years with non‐radiating, non‐specific low back pain lasting for more than 3 months. Exclusion criteria were: abnormal neurological status; concomitant severe disease; psychiatric illness; current psychotherapy; pathological lumbosacral X‐rays (except for minor degenerative changes); rheumatic inflammatory disease; planned hospitalisation; addiction to any kind of substance; and any contraindication to ultrasound therapy. | |
Interventions | Intervention (I) group (n = 5) received 1 MHz continuous ultrasound, at 1.5 W/cm² for 10 sessions, 3 days per week. Duration of ultrasound application was calculated according to the formula: total treatment time = planned average local exposure time x (tissue area/effective radiation area of applicator). Control (C) group (n = 5) received placebo ultrasound for 10 sessions, 3 days per week. |
|
Outcomes | Mean (SD) pre‐ and post‐treatment scores on Functional Rating Index were: (I) 56.5 (20.35), 34.5 (13.5); and (C) 46.95 (14.38), 39.9 (16.5). Mean (SD) pre‐ and post‐treatment degrees of flexion range of motion were: (I) 117.4 (2.5), 128.6 (14.3); and (C) 103.4 (13.39), 109.2 (10.6). Mean (SD) pre‐ and post‐treatment degrees of extension range of motion were: (I) 23.8 (4.15), 30 (6.4); and (C) 27.2 (3.03), 29 (4.2). No between‐group difference was seen for H‐reflex parameters (electroneurophysiological evaluation) or in lumbar spine lateral flexion (left and right) range of motion. |
|
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) | 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 measure is self‐reported, participants blind to group allocation. |
Incomplete outcome data (attrition bias) Dropout rate described | High risk | Dropout rate described, 30% of sample dropped out. |
Incomplete outcome data (attrition bias) Intention‐to‐treat | High risk | Participants who dropped out were excluded from analysis. |
Selective reporting (reporting bias) | Unclear risk | No trial pre‐registration or published protocol was available. |
Similar groups | High risk | Large differences in gender, age, BMI between groups |
Co‐interventions | Low risk | Participants advised not to commence new treatments. |
Compliance | High risk | High proportion of dropouts due to noncompliance. |
Timing of outcome measures | Low risk | Similar timing of outcome assessment (post‐treatment) for both groups. |