{
  "abstract": "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 (t 0), 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.",
  "authors": [
    {
      "affiliations": [
        "Research Department, Osteopathie Schule Deutschland, Hamburg, Germany",
        "Institute of Interdisciplinary Exercise Science and Sports Medicine & Institute for Clinical Psychology and Psychotherapy, Medical School Hamburg, Hamburg, Germany"
      ],
      "name": "Lucas Bohlen"
    },
    {
      "affiliations": [
        "Center for Mental Health, Immanuel Hospital Rüdersdorf, Brandenburg Medical School Theodor Fontane, Rüdersdorf, Germany"
      ],
      "name": "Michael Eggart"
    },
    {
      "affiliations": [
        "Charité University Medicine Berlin, Berlin, Germany",
        "Faculty of Medicine and Psychology, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany"
      ],
      "name": "Bruno Müller-Oerlinghausen"
    },
    {
      "affiliations": [
        "Department of Biomedical Engineering, Faculty of Life Science, University of Applied Sciences, Hamburg, Germany"
      ],
      "name": "Jürgen Lorenz"
    },
    {
      "affiliations": [
        "Professorship of Conservative and Rehabilitive Orthopaedics, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany",
        "DIPLOMA Hochschule, Bad Sooden-Allendorf, Germany"
      ],
      "name": "Robert Schleip"
    },
    {
      "affiliations": [
        "Research Department, Osteopathie Schule Deutschland, Hamburg, Germany",
        "Liem Institut for Psychosomatic Osteopathy, Hamburg, Germany"
      ],
      "name": "Torsten Liem"
    },
    {
      "affiliations": [
        "Clinical-Based Human Research Department, Foundation COME Collaboration, Pescara, Italy",
        "College of Osteopathic Medicine, New York Institute of Technology, Old Westbury, New York, USA"
      ],
      "name": "Francesco Cerritelli"
    },
    {
      "affiliations": [
        "Clinical-Based Human Research Department, Foundation COME Collaboration, Pescara, Italy",
        "Escola Superior de Saúde Atlântica, Barcarena, Portugal"
      ],
      "name": "Jorge E Esteves"
    },
    {
      "affiliations": [
        "Institute for Clinical Psychology and Psychotherapy & Department of Psychology, Medical School Hamburg, Hamburg, Germany",
        "Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"
      ],
      "name": "Meike Shedden-Mora"
    },
    {
      "affiliations": [
        "Research Department, Osteopathie Schule Deutschland, Hamburg, Germany",
        "Institute of Interdisciplinary Exercise Science and Sports Medicine, Medical School Hamburg, Hamburg, Germany"
      ],
      "name": "Tobias Schmidt"
    }
  ],
  "title": "Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial",
  "uid": "b4f7071d-38f3-5f2a-bed9-27564d249635"
}