Mohseni‐Bandpei 2006.
| Study characteristics | ||
| Methods | RCT conducted in outpatient physiotherapy department (secondary care setting) | |
| Participants | 120 individuals aged between 18 and 55 years with pain greater than 3 months were recruited and randomised into 2 groups of 60 participants. Individuals were excluded if they had an underlying disease such as malignancy, obvious disc herniation, osteoporosis, viscerogenic causes, infection or systemic disease of the musculoskeletal system; previous spinal manipulation therapy or ultrasound treatment; neurologic or sciatic nerve root compression, radicular pain, sensory disturbances, loss of strength and reflexes; previous back surgery; evidence of previous vertebral fractures or major structural abnormality; tumour of the spine; pregnancy; devices such as heart pacemakers that could be affected by electrical stimulation; or registered disabled or receiving any type of benefits because of their LBP. | |
| Interventions | The manipulation/exercise group (n = 56) received spinal manipulation with an exercise programme. On average, each participant was seen for 4 sessions (range 2 to 7 sessions), once or twice per week. The ultrasound/exercise group (n = 56) received ultrasound with the same exercise programme. Continuous ultrasound with a frequency of 1 MHz and intensity between 1.5 and 2.5 W/cm² for a period of 5 to 10 minutes was applied. On average, each participant was seen for 6 sessions (range 3 to 11 sessions), once or twice per week. |
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| Outcomes | 112 participants completed the study. Post‐treatment, between‐group analysis showed that participants in the manipulation/exercise group demonstrated a significantly greater reduction in pain intensity and functional disability, as well as improved lumbar flexion and extension, than the ultrasound/exercise group. No significant difference was found between groups for measures of median frequency for either the multifidus or the iliocostalis lumborum muscle. A significant difference was found in the median frequency slope between groups for multifidus alone in favour of the manipulation/exercise group. These differences persisted at the 6‐month follow‐up. | |
| 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 | "Block style randomization scheme" with reference |
| Allocation concealment (selection bias) | Unclear risk | Not reported in text |
| Blinding of participants and personnel (performance bias) Participants | High risk | Participants not blinded to intervention. |
| Blinding of participants and personnel (performance bias) Care providers | High risk | Care providers not blinded to group. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessor blinded to group allocation, however primary outcome was self‐reported, and participants were not blinded to intervention. |
| Incomplete outcome data (attrition bias) Dropout rate described | Low risk | Described and acceptable |
| Incomplete outcome data (attrition bias) Intention‐to‐treat | High risk | Dropouts excluded from analysis. |
| 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 |
BMI: body mass index BNR: beam non‐uniformity ratio LBP: low back pain RCT: randomised controlled trial SD: standard deviation US: ultrasound VAS: visual analogue scale
ROM: Range of Motion
SF‐36:Short Form Health Survey questionnaire
PRI/PPI: Pain Rating Index/present pain intensity