Galantino 2004.
Study characteristics | ||
Methods | Randomized controlled parallel‐group trial. | |
Participants | 22 participants with chronic LBP. Settings: setting for trial and location of yoga intervention delivery not described. Country: USA. Recruitment: self‐referral through newspaper advertisements and referral through healthcare practitioners. Inclusion criteria: men and women aged 30–65 years with back pain for > 6 months and > 2 previous conservative medical interventions (physical therapy and chiropractic) without prolonged relief. Exclusion criteria: current history of chronic systemic disease, previous yoga experience, changes in pain medication during past 14 days. |
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Interventions |
Yoga group: (n = 11) formal 1‐hour hatha yoga class twice per week for 6 weeks. Home practice: suggested 1 hour per day but not mandated or monitored. Control group: (n = 11) no treatment during observation period. Common interventions: usual care continued for both groups. Co‐interventions: changes in pain medication were not allowed during study. Duration and follow‐up: interventions provided for 6 weeks and there was an additional follow‐up at 3 months for yoga participants only. |
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Outcomes | Back‐specific function (Oswestry Disability Index) at 6 weeks. Depression (Beck Depression Inventory) at 6 weeks. Other outcomes collected: Sit and Reach Test and Functional Reach Test. |
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Notes | Adverse events: no discussion of safety or adverse events. Measurement of expectations or treatment preferences at baseline: none. Funding: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used random numbers to generate sequence. |
Allocation concealment (selection bias) | Unclear risk | No details reported in publication. |
Blinding of participants | High risk | No blinding as control participants received no treatment; outcomes based on self‐assessment. |
Blinding of personnel/providers | High risk | No blinding. |
Blinding of outcome assessors | High risk | Participants were not blinded, and outcomes were self‐reported. No mention of blinding of those who collected the information on outcomes from the participants. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition > 30% in control group. 6/11 control group participants had missing outcomes and were treated as 'failures' in a dichotomous analysis. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Group similarity at baseline | High risk | Beck Depression Inventory substantially higher in control group. |
Co‐interventions | Unclear risk | Not possible to assess; recorded by participants but not reported. |
Compliance | Unclear risk | No information on class attendance. |
ITT analysis | Low risk | ITT analysis stated. |
Timing of outcome assessments | Low risk | Outcome assessments at a set point. |
Other bias | Low risk | No other biases identified. |