M99.0 M54.5
Conditions
Interventions
Group 1: The intervention group will receive two thirty-minute sessions (two weeks apart) of individualized osteopathic manipulative treatment (OMT group). At the first session, an anamnesis, inspecti
Sponsors
Osteopathie Schule Deutschland
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: For healthy subjects: Asymptomatic people with sufficient German language skills. For patients with chronic low back pain: People with non-specific (no known underlying pathology) chronic (> 3 months) low back pain (pain between the costal margins and gluteal folds). Subjects must report clinically relevant pain levels (> 3 on the Numeric Rating Scale) and disability levels (> 30 on the Oswestry Disability Index) and must have sufficient German language skills.
Exclusion criteria
Exclusion criteria: For healthy subjects: People cannot participate if they report: (1) systemic diseases; (2) intake of medications (two weeks before the first treatment session) except for the birth control pill; (3) vigorous physical activity or receiving manual therapy (two days before each treatment session); (4) acute or chronic musculoskeletal injuries or conditions; and (5) smoking, alcohol, or coffee consumption as well as eating a meal (two hours before each measurement). For patients with chronic low back pain: People cannot participate if they report: (1) specific spine conditions like spondylolisthesis, spinal stenosis, spondylolysis, nerve root compromise, disc herniation, neurological signs, or osteoporosis; (2) other disorders like inflammatory, rheumatological, psychiatric, respiratory, oncological, and cardiac conditions; (3) previous trauma or surgery of the back and spine; (4) vigorous physical activity or receiving manual therapy (two days before each treatment session); (5) smoking, alcohol, or coffee consumption as well as eating a meal (two hours before each measurement); and (6) pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As primary outcomes, the interoceptive accuracy and sensibility of subjects will be evaluated using the Heartbeat Counting Task (HCT) and the Multidimensional Assessment of Interoceptive Awareness 2 (MAIA-2) questionnaire. The HCT will be assessed before and after the first and second treatment sessions (t1 and t2) and at follow-up one month after the second treatment session (t3). The MAIA-2 will be assessed at baseline (t0), after the first and second treatment sessions (t1 and t2), and at follow-up one month after the second treatment session (t3). | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, the pain and disability levels will be assessed with the Numeric Rating Scale (NRS) and the Oswestry Disability Index (ODI) in patients with chronic low back pain (but not healthy subjects). The NRS and ODI will be evaluated at baseline (t0), after the first and second treatment sessions (t1 and t2), and at follow-up one month after the second treatment session (t3). As a tertiary outcome, the heart rate variability (HRV) will be assessed with electrocardiography (ECG). The ECG will be used before and after the first and second treatment sessions (t1 and t2) and at follow-up one month after the second treatment session (t3). Additionally, clinical and demographic data (age, sex, height, weight, body mass index, education, marital status, employment, sporting activity, and previous experience with osteopathic treatment [for healthy subjects and patients with chronic low back pain] as well as the duration of low back pain, concomitant care, and medications [only for patients with chronic low back pain]) will be collected, and the adverse event and blinding concealment rates will be calculated. The clinical and demographic data will be recorded at baseline (t0). The adverse events will be assessed after the first and second treatment sessions (t1 and t2) and at follow-up one month after the second treatment session (t3). The blinding concealment will be evaluated at follow-up one month after the second treatment session (t3). | — |
Countries
Germany
Contacts
Public ContactTobias Schmidt
Medical School Hamburg
Outcome results
None listed