Randomized controlled trial with Reflective Respiratory Physiotherapy for Chronic Low Back Pai

Phase 4

• Conditions: M54.5; Low back pain

• Registration Number: DRKS00024537
• Lead Sponsor: Immanuel Krankenhaus Berlin, Standort Berlin-Wannsee Abteilung Naturheilkunde und Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-07-10
• Study Start: 2021-03-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

uncomplicated chronic low back pain according to the AWMF-guidelines (no indication for a specific cause/duration > 3 months)

visual analogue scale pain >4.0/10 during periods of pain

age 18-65 years

signed consent form for participation in the study
and complete questionnaires

Exclusion Criteria

indication for a specific cause of the low back pain
(red flag in anamnesis or examination)

indication for or existing spondyloarthropathy

indication for or existing spinal stenosis

spinal disc herniation diagnosed within the past three months

planed or conducted spine-surgery

fever

acute psychiatric disease

diagnosed psychogenic pain

malign tumor disease

addiction disease (smoking excluded)

pregnancy or breastfeeding

simultaneous participation in another study

simultaneous participation in activating, non-pharmaceutical therapy regarding the low back pain

running process due to request of early retirement

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
main outcome: functional disability due to back pain, measured with the Funktionsfragebogen Hannover-Rücken. Data is collected after inclusion in the study, after three sessions and after completion of intervention. Furthermore three months after completed intervention. <br><br>Data of the waiting group is collected after inclusion in the study, after three, five and seventeen weeks.

Secondary Outcome Measures

Name	Time	Method
secondary outcome<br><br>visual analogue scale pain (0-10) of pain intensity over the past seven days<br><br>visual analogue scale subjective every-day life interference (0-10) over the past seven days<br><br>short form (36) health survey SF36<br><br>Intervention group: Data is collected after inclusion in the study, after three sessions and after completion of intervention. Furthermore three months after completed intervention. <br><br>Waiting group: Data of the waiting group is collected after inclusion in the study, after three, five and seventeen weeks.