M99.0 M54.5 F32.0 F33.0
Conditions
Interventions
Group 1: Participants in the intervention group will receive six sessions of osteopathic manipulative treatment, applied weekly for 45 minutes. An anamnesis, inspection, and manual diagnostic will be
Sponsors
Osteopathic Research Institute, Osteopathie Schule Deutschland
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
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: =15). To ensure that subjects do not fulfil the diagnosis of a moderate, severe, or bipolar 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 trained personnel closely supervised by a licensed psychological psychotherapist and professor for clinical psychology and psychotherapy. Based on the DIPS, participants will be included if they are diagnosed with subclinical depressive symptoms, mild depressive episode (ICD-10, F.32.0), or recurrent depressive disorder with a current mild depressive episode (ICD-10, F.33.0), and excluded if they are diagnosed with moderate or severe depressive episode (ICD-10, F.32.1-3), or bipolar affective disorder (ICD-10, F.31). Participants who will be diagnosed with moderate or severe depression or bipolar affective disorder 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, severe, or bipolar depression is diagnosed (termination criteria).
Exclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. Additionally, clinical and demographic data (age, sex, height, weight, education, employment, smoking, prior experience with OMT, duration of symptoms [depressive symptoms and back pain], 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). Furthermore, a pilot run with twenty subjects (ten per group) will be conducted to investigate the feasibility of the trial by means of retention of the subjects (retention rate), safety of the interventions (adverse events rate), and satisfaction with the interventions (satisfaction rate). The retention rate must be >80% and will be assessed between baseline (t0) and follow-up (t7). The adverse events rate must be <6% and adverse events will be assessed at the first, second, third, fourth, fifth, and sixth session (t1-t6) (before the interventions) and at follow-up (t7) three months after the sixth treatment session. The average patient satisfaction must not be <4 and will be assessed at follow-up (t7). Lastly, the blinding concealment will be assessed (blinding concealment rate) at follow-up (t7). | — |
Countries
Germany
Contacts
Public ContactTobias Schmidt
Hochschulambulanz für Sport- und Bewegungsmedizin, Medical School Hamburg
Outcome results
None listed