Patil 2018.
Study characteristics | ||
Methods | Randomized controlled parallel‐group trial. | |
Participants | 88 nurses with chronic LBP of whom 82% had non‐specific LBP. Settings: tertiary care teaching hospital (the workplace of the nurses). Location of yoga classes not described. Country: India. Recruitment: "nurses were screened and referred by the orthopedician" however flow chart (Figure 1) stated "self and physician referred [sic]." Inclusion criteria: female nurses with diagnosis of non‐specific LBP, lumbar spondylosis, or intervertebral disk prolapse; LBP for ≥ 3 months as diagnosed by an orthopedician and knowledge of English, Hindi, and Kannada language. Exclusion criteria: pain due to organic causes such as infective and inflammatory conditions, metabolic disorders, and post‐traumatic condition; degenerative disorders of muscles; comorbid cardiac or neuropsychiatric illness; history of major surgery or injury; pregnant women; neurologic complications of chronic LBP. |
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Interventions |
Yoga group: (n = 44) 6 weeks of 60‐min yoga classes provided 5 days/week. Home practice: not mentioned. Exercise group: (n = 44) 6 weeks of 60‐min physical exercises provided 5 days/week. Common interventions: none described. Co‐interventions: no mention of included or excluded co‐interventions. Duration and follow‐up: interventions provided for 6 weeks and follow‐up finished at end of intervention. |
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Outcomes | Quality of life – mental (Psychological health scale of WHOQOL‐BREF questionnaire English and Keralan version at 6 weeks. Quality of life – physical (physical health scale of the WHOQOL‐BREF) at 6 weeks. Other outcomes collected: Social Relationships scale of the WHOQOL‐BREF, Environmental Health scale of the WHOQOL‐BREF. |
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Notes | Adverse events: no mention of assessment of adverse events. Measurement of expectations or treatment preferences at baseline: none. Funding: report stated there was no financial support or sponsorship. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: used random number generator (www.randomizer.org). |
Allocation concealment (selection bias) | Unclear risk | Comment: no mention of allocation concealment. |
Blinding of participants | High risk | No blinding. |
Blinding of personnel/providers | High risk | No blinding. |
Blinding of outcome assessors | High risk | Comment: participants not blinded and outcomes based on self‐report. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "There were no dropouts in the study." |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Group similarity at baseline | Low risk | Quote: "Participants in the two groups did not differ much in relation to their age, education, or duration of illness between the groups as shown in Table 1." Quote: "There was a no significant difference between the yoga and control groups at the baseline for all the four domains of WHOQOLBREF: (a) physical (P = 0.296), (b) psychological (P = 0.987), (c) social (P = 0.661), and (d) environmental (P = 0.904) as shown in Table 5." |
Co‐interventions | Unclear risk | Comment: no mention of medication use at baseline, or any permitted or disallowed co‐interventions during study. |
Compliance | Unclear risk | Comment: no mention of compliance or adherence. |
ITT analysis | Unclear risk | Comment: no mention of ITT analysis. |
Timing of outcome assessments | Low risk | Quote: "Data were taken at the same time of the day on the 1 and 43 day. Orientation to yoga program was given to the participants for 3 days, and then on the next day, predata collection was done after satisfactory performance. WHOQOLBREF assessments were done on day 1 and day 43 (after 6 weeks)." |
Other bias | Low risk | No other biases identified. |