Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: A randomised controlled trial

Not Applicable

• Conditions: M99.0; M54.5; F32.0; F33.0; Segmental and somatic dysfunction; Low back pain; Mild depressive episode; Recurrent depressive disorder, current episode mild

• Registration Number: DRKS00031694
• Lead Sponsor: Osteopathic Research Institute, Osteopathie Schule Deutschland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants must report chronic low back pain (CLBP) and comorbid depressive symptoms (DS). Subjects must show pain in the lumbar region that persists for more than 3 months (chronic) and has no recognized underlying pathology (non-specific). Furthermore, participants must demonstrate clinically relevant baseline levels of depression (BDI-II: =7), pain (NRS: =3), and disability (ODI: =30).
To ensure that subjects do not fulfil the diagnosis of a moderate or severe major depression (based on DSM-5), a structured diagnostic interview (Diagnostic Interview for Mental Disorders [DIPS]) will be conducted at baseline (t0). The interviews will be conducted by a licensed general practitioner who will be trained and supervised by a licensed psychological psychotherapist and professor for clinical psychology and psychotherapy. Based on the DIPS, participants will be diagnosed with no or mild depression (inclusion) and moderate or severe depression (exclusion). Participants who will be diagnosed with moderate or severe depression at baseline cannot participate in the trial and will be referred to the university outpatient clinic for psychotherapy of the Medical School Hamburg (MSH) for further diagnosis and treatment. Notably, if the DS deteriorate during the study (defined as BDI-II score >20), a new DIPS will be conducted, and the subject will be excluded from participation if a moderate or severe depression is diagnosed (termination criteria).

Exclusion Criteria

Subjects will be prohibited from participation if they report: (1) pregnancy, (2) malignancy, (3) obesity (body mass index [BMI]: >30), (4) trauma, surgeries, or diseases of the spine (e.g., fractures, spinal fusion, or spondylolisthesis), (5) mental disorders (other than depression), (6) substance abuse/dependence, (7) active suicidal ideation, (8) short duration of DS (<2 weeks), (9) systematic conditions (e.g., inflammatory, immunological, or rheumatological diseases), or (10) an inability to provide informed consent (e.g., due to insufficient language skills).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primarily, the symptoms of depression, pain, and disability of participants will be assessed using the Beck`s Depression Inventory, Second Edition (BDI-II), Numeric Rating Scale (NRS), and Oswestry Disability Index (ODI). The primary outcomes will be evaluated at baseline (t0), the first (t1), third (t3), and sixth (t6) treatment session (before the interventions) and at follow-up (t7) three month after the sixth treatment session.

Secondary Outcome Measures

Name	Time	Method
Secondarily, the interoceptive accuracy, sensibility, and awareness of participants will be evaluated using the Heartbeat Tracking Task (HTT), Multidimensional Assessment of Interoceptive Awareness (MAIA-2), and confidence-accuracy correspondence (CAC). The secondary outcomes will be assessed at the first (t1), third (t3), and sixth (t6) treatment session (before the interventions) and at follow-up (t7) three month after the sixth treatment session.<br>Additionally, clinical and demographic data (age, sex, height, weight, education, employment, smoking, duration of symptoms [depressive symptoms and back pain and disability], concomitant care, and medication) will be collected and the therapeutic alliance will be evaluated with the Helping Alliance Questionnaire (HAQ). The clinical and demographic data will be recorded at baseline (t0) and the therapeutic alliance will be assessed at the third (t3) and sixth (t6) treatment session (before the interventions).