Effect of osteopathic manipulative treatment on interoceptive accuracy and sensibility in healthy subjects and patients with chronic low back pain: A randomised controlled trial

Not Applicable

• Conditions: M99.0; M54.5; Segmental and somatic dysfunction; Low back pain

• Registration Number: DRKS00034306
• Lead Sponsor: Osteopathie Schule Deutschland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 68

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).