Osteopathic treatment in patients with chronic muskuloskelettal disorders - an observational study

• Conditions: chronic neck pain, chronic low back pain, chronic shoulder pain or chronic knee pain; M99.01; M99.02; M99.03; M99.06; M99.07; M54.2; M54.5; M17.9; M75.4

• Registration Number: DRKS00008319
• Lead Sponsor: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-28
• Study Completion: 2017-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

30 to 65 years of age, female or male
- clinical diagnosis „chronic neck pain i.e. neck pain for at least 12 weeks, „chronic low back pain i.e. low back pain for at least 12 weeks, „chronic shoulder pain i.e. shoulder pain for at least 12 weeks, „chronic knee pain i.e. knee pain for at least 12 weeks
- intensity of the average muskuloskelettal pain over the last 7 days had to be more than 40 mm on a 100-mm visual analogue scale (VAS)
- willingness to get 6 osteopathic treatments within the next 6 month
- ability to give oral and signed written informed consent
- written informed consent

Exclusion Criteria

- osteopathic treatment within the last 12 month before beginn of study
- neck pain, low back pain, shoulder pain or knee pain caused by a malignant disease, infection or recent trauma
- kwown or suspected primary or secundary bone tumor
- known vascular anomaly such as aneurysm
- peripher or central neurological symptoms
- rheumatic diseases
- Joint replacements or other implants in the region of treatment
- obesity with BMI >30 Kg/m2
- intake of centrally acting analgesics
- pregnancy or breast feeding
- severe acute and or chronic disease which does not allow participation in the therapy
- other limitations which do not allow participation in the therapy
- alcohol or substance abuse
- no sufficient knowledge of German language
- current application for a benefit
- participation in another clinical trial during six months before the study and parallel to the study
- absence of written informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome measures (Baseline, after 12, 26 and 52 weeks)<br>- average pain intensity on visual analogue scale (VAS, 0–100 mm, 0 = no pain, 100= worst imaginable pain) <br>- SF-12 health related quality of life<br>- days of disability due to muskuloskelettal pain within last 4 weeks<br>- medication intake (analgetics) due to muskuloskelettal pain within the last 7 days<br>- use of additional therapy within last 4 weeks<br><br>For the 4 different muskuloskelettal disorders each one will be evaluated by a special outcome measurement:<br>- Neck Disability Index (NDI) for neck pain<br>- Low Back Pain Rating Scale for Low back pain<br>- Disabilities of Arm, Shoulder and Hand (DASH) for shoulder pain<br>- Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index for knee pain<br><br>