Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial
Introduction Chronic low back pain (CLBP) and depressive symptoms (DS) are highly prevalent, burdensome, costly and comorbid health conditions. Osteopathic manipulative treatment (OMT) was shown to improve pain and disability in patients with CLBP; however, the effect on comorbid DS remains less cer...
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BMJ Publishing Group
2025-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/7/e094747.full |
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| author | Meike Shedden-Mora Robert Schleip Francesco Cerritelli Tobias Schmidt Lucas Bohlen Michael Eggart Bruno Müller-Oerlinghausen Jürgen Lorenz Torsten Liem Jorge E Esteves |
| author_facet | Meike Shedden-Mora Robert Schleip Francesco Cerritelli Tobias Schmidt Lucas Bohlen Michael Eggart Bruno Müller-Oerlinghausen Jürgen Lorenz Torsten Liem Jorge E Esteves |
| author_sort | Meike Shedden-Mora |
| collection | DOAJ |
| description | Introduction Chronic low back pain (CLBP) and depressive symptoms (DS) are highly prevalent, burdensome, costly and comorbid health conditions. Osteopathic manipulative treatment (OMT) was shown to improve pain and disability in patients with CLBP; however, the effect on comorbid DS remains less certain. Interestingly, CLBP and DS seem to be associated with changes in interoception, which may be reversed by OMT.Methods and analysis The study protocol proposes a single-blinded, parallel-group, randomised controlled trial to investigate the effect of OMT on clinical symptoms (depression, pain and disability) and interoceptive functions (interoceptive accuracy, sensibility and awareness) in patients with CLBP and comorbid DS. A sample of 60 adult subjects with CLBP and comorbid DS shall be recruited from osteopathic, orthopaedic and physiotherapeutic practices and educational institutes for osteopathy, sports science, psychology and medicine in Hamburg, Germany. Participants will be randomly allocated (1:1 ratio) to receive six 45 min treatment sessions of either OMT (standard-OMT group) or sham treatment imitating OMT (sham-OMT group). Primarily, symptoms of depression, pain and disability will be assessed with the Beck’s Depression Inventory, Second Edition (BDI-II), Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI). Secondarily, interoceptive accuracy, sensibility and awareness will be evaluated using the Heartbeat Tracking Task (HTT), Multidimensional Assessment of Interoceptive Awareness (MAIA-2) and confidence-accuracy correspondence (CAC). Ancillary, the therapeutic alliance will be investigated with the Helping Alliance Questionnaire. Data will be collected at baseline (t0), the first, third and sixth treatment sessions (t1, t3, t6) and at 3 months follow-up (t7). The findings will be analysed for between-group differences using descriptive (mean and SD) and inductive statistics (mixed analysis of variance). It is hypothesised that standard-OMT, compared with sham-OMT, will reduce depression, pain and disability (BDI-II, NRS, ODI) and increase interoceptive accuracy, sensibility and awareness (HTT, MAIA-2, CAC) in patients with CLBP and comorbid DS.Ethics and dissemination The study was approved by the ethics committee of the Medical School Hamburg (MSH-2023/288). The anonymised dataset will be published in an online repository, and the results will be published in peer-reviewed scientific journals.Trial registration number DRKS00031694. |
| format | Article |
| id | doaj-art-b52f240e05564a21aa5879901495fbdf |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-b52f240e05564a21aa5879901495fbdf2025-08-20T02:46:14ZengBMJ Publishing GroupBMJ Open2044-60552025-07-0115710.1136/bmjopen-2024-094747Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trialMeike Shedden-Mora0Robert Schleip1Francesco Cerritelli2Tobias Schmidt3Lucas Bohlen4Michael Eggart5Bruno Müller-Oerlinghausen6Jürgen Lorenz7Torsten Liem8Jorge E Esteves9Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyProfessorship of Conservative and Rehabilitive Orthopaedics, TUM School of Medicine and Health, Technical University of Munich, Munich, GermanyClinical-Based Human Research Department, Foundation COME Collaboration, Pescara, ItalyResearch Department, Osteopathie Schule Deutschland, Hamburg, GermanyInstitute of Interdisciplinary Exercise Science and Sports Medicine & Institute for Clinical Psychology and Psychotherapy, Medical School Hamburg, Hamburg, GermanyCenter for Mental Health, Immanuel Hospital Rüdersdorf, Brandenburg Medical School Theodor Fontane, Rüdersdorf, GermanyCharité University Medicine Berlin, Berlin, GermanyDepartment of Biomedical Engineering, Faculty of Life Science, University of Applied Sciences, Hamburg, GermanyResearch Department, Osteopathie Schule Deutschland, Hamburg, GermanyClinical-Based Human Research Department, Foundation COME Collaboration, Pescara, ItalyIntroduction Chronic low back pain (CLBP) and depressive symptoms (DS) are highly prevalent, burdensome, costly and comorbid health conditions. Osteopathic manipulative treatment (OMT) was shown to improve pain and disability in patients with CLBP; however, the effect on comorbid DS remains less certain. Interestingly, CLBP and DS seem to be associated with changes in interoception, which may be reversed by OMT.Methods and analysis The study protocol proposes a single-blinded, parallel-group, randomised controlled trial to investigate the effect of OMT on clinical symptoms (depression, pain and disability) and interoceptive functions (interoceptive accuracy, sensibility and awareness) in patients with CLBP and comorbid DS. A sample of 60 adult subjects with CLBP and comorbid DS shall be recruited from osteopathic, orthopaedic and physiotherapeutic practices and educational institutes for osteopathy, sports science, psychology and medicine in Hamburg, Germany. Participants will be randomly allocated (1:1 ratio) to receive six 45 min treatment sessions of either OMT (standard-OMT group) or sham treatment imitating OMT (sham-OMT group). Primarily, symptoms of depression, pain and disability will be assessed with the Beck’s Depression Inventory, Second Edition (BDI-II), Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI). Secondarily, interoceptive accuracy, sensibility and awareness will be evaluated using the Heartbeat Tracking Task (HTT), Multidimensional Assessment of Interoceptive Awareness (MAIA-2) and confidence-accuracy correspondence (CAC). Ancillary, the therapeutic alliance will be investigated with the Helping Alliance Questionnaire. Data will be collected at baseline (t0), the first, third and sixth treatment sessions (t1, t3, t6) and at 3 months follow-up (t7). The findings will be analysed for between-group differences using descriptive (mean and SD) and inductive statistics (mixed analysis of variance). It is hypothesised that standard-OMT, compared with sham-OMT, will reduce depression, pain and disability (BDI-II, NRS, ODI) and increase interoceptive accuracy, sensibility and awareness (HTT, MAIA-2, CAC) in patients with CLBP and comorbid DS.Ethics and dissemination The study was approved by the ethics committee of the Medical School Hamburg (MSH-2023/288). The anonymised dataset will be published in an online repository, and the results will be published in peer-reviewed scientific journals.Trial registration number DRKS00031694.https://bmjopen.bmj.com/content/15/7/e094747.full |
| spellingShingle | Meike Shedden-Mora Robert Schleip Francesco Cerritelli Tobias Schmidt Lucas Bohlen Michael Eggart Bruno Müller-Oerlinghausen Jürgen Lorenz Torsten Liem Jorge E Esteves Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial BMJ Open |
| title | Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial |
| title_full | Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial |
| title_fullStr | Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial |
| title_full_unstemmed | Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial |
| title_short | Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial |
| title_sort | effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/7/e094747.full |
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