Kumar 2010.
| Methods | Randomised controlled trial | |
| Participants | A total of 141 (male/female) LBP patients from Department of Physical Medicine and Rehabilitation, CSM Medical University, Lucknow, aged 20 to 40 years who were diagnosed clinically by a physician with no neurological involvement, non‐specific, sub‐acute or chronic low back pain were included in this study Exclusion criteria: neurological involvement |
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| Interventions | After group allocations, respective participants were treated either with conventional (CONV) or dynamic muscular stabilisation treatment (DMST) in a single‐blind manner (i.e. patients were not aware of the treatment groups). Both the treatments were given as individual treatments by the same physiotherapist with the same intensity and capacity on 20 regular days and followed up for 180 days. Follow‐up was started after 20 days of regular exercises at OPD, which was ended after 6 months from the 0 day. During follow‐up, participants had an appointment periodically with the investigator at 15‐day intervals for review of exercises. The duration of each individual treatment session was about 40 minutes per day. The participants were not allowed to get any other treatment options including the pain killers. Dynamic muscular stabilisation treatment (DMST): in DMST, muscles with direct attachment to the lumbar spinal segment stabilise the joint's 'neutral zone' and prevent excessive deflection. Details of the DMST exercise programme are described elsewhere. Conventional treatment: consisted of ultrasound (1 MHz continuous at an intensity of 1.2 W per cm square for 5 minutes). Short‐wave diathermy (continuous mode of SWD for 15 minutes) and the lumbar strengthening exercises (10 repetitions each of prone lying leg elevation, prone lying chest elevation and supine lying bridging). Participants received 20 sitting in 20 regular days. Ultrasound and short‐wave diathermy equipment from Medichem Electronics were used in the study, which has international standard certification |
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| Outcomes | Pain (NRS 0 to 10) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The subjects were randomised equally in two groups by lottery method" |
| Allocation concealment (selection bias) | Unclear risk | Not enough information regarding this topic |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "...patients were not aware of the treatments groups..." |
| Blinding of personnel/care provider (performance bias) All outcomes | High risk | No mention of any attempts to blind the care provider |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Considered, as the participants were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
| Intention‐to‐treat analysis | High risk | No mention of intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Low risk | No previous protocol or trial registration, but it was clear that the published report included all expected outcomes |
| Group similarity at baseline (selection bias) | Low risk | Patients did not differ in their baseline characteristics |
| Co‐interventions (performance bias) | Unclear risk | Not reported |
| Compliance (performance bias) | Low risk | Compliance was considered similar for both groups |
| Timing of outcome assessment (detection bias) | Low risk | All important outcome assessments for both groups were measured at the same time |