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. 2020 Jul 5;2020(7):CD009169. doi: 10.1002/14651858.CD009169.pub3

Durmus 2013.

Study characteristics
Methods RCT conducted in outpatient department (secondary care setting)
Participants 64 female patients who had been experiencing low back pain for at least 3 months were included. Exclusion criteria were: acute radicular signs or symptoms, radiographic evidence of inflammatory disease affecting the spine, tumour, spondylolysis, spondylolisthesis, or sacroiliitis, serious medical conditions for which exercise would be contraindicated, neuromuscular or dermatologic disease that involves the lumbar and abdominal area, were currently in an exercise programme, implanted cardiac pacemaker or defibrillator, contracture, previous trauma, history of spinal surgery, pregnancy, presence of severe structural deformity.
Interventions Group 1 (n = 20) was given a group exercise programme for 60 min, 3 times per week for 6 weeks.
Group 2 (n = 20) was given a 10‐minute ultrasound treatment (1 MHz frequency and 1.5 W/cm² intensity and a transducer head with an area of 5 cm, an effective radiating area of 4 cm, and a BNR of 1:5), 3 times per week for 6 weeks, and the same exercise programme as group 1.
Group 3 (n = 20) was given phonophoresis therapy by applying 2 to 3 mm of capsaicin gel (10% capsicum oleoresin in 0.22% solution) then a 10‐minute ultrasound treatment (as per group 2), 3 times per week for 6 weeks, as well as the same exercise programme as group 1.
Participants were evaluated pre‐treatment and after 6 weeks (post‐treatment).
Outcomes 60 participants completed the study. The post‐treatment (6‐week) between‐group comparison showed a significant difference in VAS pain, walking performance (6‐minute walk test), and extensor muscle strength in favour of groups 2 and 3 compared to group 1. There was no significant difference between groups 2 and 3.
There was a significantly greater improvement in pain, physical function, and energy subscales of the SF‐36 in group 3 compared to groups 1 and 2.
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 High risk Participants not blinded to intervention.
Blinding of participants and personnel (performance bias)
Care providers High risk Care providers not blinded.
Blinding of outcome assessment (detection bias)
All outcomes High risk Self‐reported primary outcome, participants 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 Low risk Medication controlled during intervention period.
Compliance Unclear risk Not reported in text
Timing of outcome measures Low risk Similar timing of outcome assessment (post‐treatment) for both groups