'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy
Abstract Background Blinding is essential for mitigating biases in trials of low back pain (LBP). Our main objectives were to assess the feasibility of blinding: (1) participants randomly allocated to active or placebo spinal manual therapy (SMT), and (2) outcome assessors. We also explored blinding...
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BMC
2025-01-01
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| Series: | Chiropractic & Manual Therapies |
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| Online Access: | https://doi.org/10.1186/s12998-024-00561-0 |
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| author | Javier Muñoz Laguna Astrid Kurmann Léonie Hofstetter Emanuela Nyantakyi Julia Braun Lauren Clack Heejung Bang Mazda Farshad Nadine E. Foster Milo A. Puhan Cesar A. Hincapié the SALuBRITY Blinding Clinician Group |
| author_facet | Javier Muñoz Laguna Astrid Kurmann Léonie Hofstetter Emanuela Nyantakyi Julia Braun Lauren Clack Heejung Bang Mazda Farshad Nadine E. Foster Milo A. Puhan Cesar A. Hincapié the SALuBRITY Blinding Clinician Group |
| author_sort | Javier Muñoz Laguna |
| collection | DOAJ |
| description | Abstract Background Blinding is essential for mitigating biases in trials of low back pain (LBP). Our main objectives were to assess the feasibility of blinding: (1) participants randomly allocated to active or placebo spinal manual therapy (SMT), and (2) outcome assessors. We also explored blinding by levels of SMT lifetime experience and recent LBP, and factors contributing to beliefs about the assigned intervention. Methods A two-parallel-arm, single-centre, placebo-controlled, blinding feasibility trial. Adults were randomised to active SMT (n = 40) or placebo SMT (n = 41). Participants attended two study visits for their assigned intervention, on average seven days apart. The primary outcome was participant blinding (beliefs about assigned intervention) using the Bang blinding index (BI) at two study visits. The Bang BI is arm-specific, chance-corrected, and ranges from − 1 (all incorrect beliefs) to 1 (all correct beliefs), with 0 indicating equal proportions of correct and incorrect beliefs. Secondary outcomes included factors contributing to beliefs about the assigned intervention. Results Of 85 adults screened, 81 participants were randomised (41 [51%] with SMT lifetime experience; 29 [39%] with recent LBP), and 80 (99%) completed follow-up. At study visit 1, 50% of participants in the active SMT arm (Bang BI: 0.50 [95% confidence interval (CI), 0.26 to 0.74]) and 37% in the placebo SMT arm (0.37 [95% CI, 0.10 to 0.63]) had a correct belief about their assigned intervention, beyond chance. At study visit 2, BIs were 0.36 (0.08 to 0.64) and 0.29 (0.01 to 0.57) for participants in the active and placebo SMT arms, respectively. BIs among outcome assessors suggested adequate blinding at both study visits (active SMT: 0.08 [− 0.05 to 0.20] and 0.03 [− 0.11 to 0.16]; placebo SMT: − 0.12 [− 0.24 to 0.00] and − 0.07 [− 0.21 to 0.07]). BIs varied by participant levels of SMT lifetime experience and recent LBP. Participants and outcome assessors described different factors contributing to their beliefs. Conclusions Adequate blinding of participants assigned to active SMT may not be feasible with the intervention protocol studied, whereas blinding of participants in the placebo SMT arm may be feasible. Blinding of outcome assessors seemed adequate. Further methodological work on blinding of SMT is needed. Trial registration number NCT05778396. |
| format | Article |
| id | doaj-art-e5cc64f10b754bfd91dc383aa66e6e44 |
| institution | Kabale University |
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| publishDate | 2025-01-01 |
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| spelling | doaj-art-e5cc64f10b754bfd91dc383aa66e6e442025-01-19T12:33:08ZengBMCChiropractic & Manual Therapies2045-709X2025-01-0133111110.1186/s12998-024-00561-0'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapyJavier Muñoz Laguna0Astrid Kurmann1Léonie Hofstetter2Emanuela Nyantakyi3Julia Braun4Lauren Clack5Heejung Bang6Mazda Farshad7Nadine E. Foster8Milo A. Puhan9Cesar A. Hincapié10the SALuBRITY Blinding Clinician GroupMusculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University HospitalMusculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University HospitalMusculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University HospitalInstitute for Implementation Science in Health Care (IfIS), Medical Faculty, University of ZurichEpidemiology, Biostatistics and Prevention Institute (EBPI), University of ZurichInstitute for Implementation Science in Health Care (IfIS), Medical Faculty, University of ZurichDivision of Biostatistics, Department of Public Health Sciences, School of Medicine, University of CaliforniaUniversity Spine Centre Zurich (UWZH), Balgrist University Hospital, University of ZurichSTARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North HealthEpidemiology, Biostatistics and Prevention Institute (EBPI), University of ZurichMusculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University HospitalAbstract Background Blinding is essential for mitigating biases in trials of low back pain (LBP). Our main objectives were to assess the feasibility of blinding: (1) participants randomly allocated to active or placebo spinal manual therapy (SMT), and (2) outcome assessors. We also explored blinding by levels of SMT lifetime experience and recent LBP, and factors contributing to beliefs about the assigned intervention. Methods A two-parallel-arm, single-centre, placebo-controlled, blinding feasibility trial. Adults were randomised to active SMT (n = 40) or placebo SMT (n = 41). Participants attended two study visits for their assigned intervention, on average seven days apart. The primary outcome was participant blinding (beliefs about assigned intervention) using the Bang blinding index (BI) at two study visits. The Bang BI is arm-specific, chance-corrected, and ranges from − 1 (all incorrect beliefs) to 1 (all correct beliefs), with 0 indicating equal proportions of correct and incorrect beliefs. Secondary outcomes included factors contributing to beliefs about the assigned intervention. Results Of 85 adults screened, 81 participants were randomised (41 [51%] with SMT lifetime experience; 29 [39%] with recent LBP), and 80 (99%) completed follow-up. At study visit 1, 50% of participants in the active SMT arm (Bang BI: 0.50 [95% confidence interval (CI), 0.26 to 0.74]) and 37% in the placebo SMT arm (0.37 [95% CI, 0.10 to 0.63]) had a correct belief about their assigned intervention, beyond chance. At study visit 2, BIs were 0.36 (0.08 to 0.64) and 0.29 (0.01 to 0.57) for participants in the active and placebo SMT arms, respectively. BIs among outcome assessors suggested adequate blinding at both study visits (active SMT: 0.08 [− 0.05 to 0.20] and 0.03 [− 0.11 to 0.16]; placebo SMT: − 0.12 [− 0.24 to 0.00] and − 0.07 [− 0.21 to 0.07]). BIs varied by participant levels of SMT lifetime experience and recent LBP. Participants and outcome assessors described different factors contributing to their beliefs. Conclusions Adequate blinding of participants assigned to active SMT may not be feasible with the intervention protocol studied, whereas blinding of participants in the placebo SMT arm may be feasible. Blinding of outcome assessors seemed adequate. Further methodological work on blinding of SMT is needed. Trial registration number NCT05778396.https://doi.org/10.1186/s12998-024-00561-0Blinding successDouble-blind methodFeasibility studyBack painManual therapyMasking |
| spellingShingle | Javier Muñoz Laguna Astrid Kurmann Léonie Hofstetter Emanuela Nyantakyi Julia Braun Lauren Clack Heejung Bang Mazda Farshad Nadine E. Foster Milo A. Puhan Cesar A. Hincapié the SALuBRITY Blinding Clinician Group 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy Chiropractic & Manual Therapies Blinding success Double-blind method Feasibility study Back pain Manual therapy Masking |
| title | 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy |
| title_full | 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy |
| title_fullStr | 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy |
| title_full_unstemmed | 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy |
| title_short | 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy |
| title_sort | which treatment do you believe you received a randomised blinding feasibility trial of spinal manual therapy |
| topic | Blinding success Double-blind method Feasibility study Back pain Manual therapy Masking |
| url | https://doi.org/10.1186/s12998-024-00561-0 |
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