Effectiveness of osteopathic medicine in patients with chronic shoulder pain - A two-arm, randomized controlled, open-label, monocentric study

Not Applicable

• Conditions: Chronic shoulder pain

• Registration Number: DRKS00034310
• Lead Sponsor: Charité - Universitätsmedizin Berlin, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Important inclusion criteria:
- Age from 18 to 65 years, any gender
- Clinical diagnosis of CSP (duration of disease at least 12 weeks, including bursitis sub-acromialis, tendinosis calcarea, frozen shoulder) on the most painful shoulder
- Subjectively perceived pain intensity at the most painful shoulder within the last seven days of at least 40 mm on a VAS (0-100 mm, 0 = no pain, 100 = worst pain imaginable)
- Willingness to forego osteopathic treatment for the next 12 weeks if the study participant is randomized to the control group
- Ability to give informed consent
- Informed consent (in paper form) is available

Exclusion Criteria

Important exclusion criteria:
- Pain in the most painful shoulder that requires urgent conventional medical treatment (e.g. muscle disease, recent trauma, SLAP (superior labrum anterior posterior) lesion)
- Peripheral and/or central neurological symptoms
- Diseases from the rheumatoid arthritis spectrum
- Shoulder surgery on the most painful shoulder within the last 6 months
- Generalized pain disorder such as fibromyalgia
- Treatment of cervical spine complaints with physical medicine currently or within the last 3 months before the start of the study
- Obesity with BMI =30 kg/m²
- Pregnancy or breastfeeding
- Presence of a serious acute and/or chronic organic or mental illness that does not allow participation in the therapy
- Lack of time resources to have the OM carried out
- Contraindications for non-steroidal anti-inflammatory drugs
- Taking centrally acting analgesics
- Treatment with OM within the last 6 months before the start of the study
- Expected lack of compliance with regard to study participation (e.g. notification that they do not wish to answer any further questions; limitation of general compliance ability in the case of dementia, severe alcohol abuse, drug abuse)
- Insufficient knowledge of the German language
- Participation in other studies
- No e-mail address available
- No skills or ability to operate or use tablets or computers independently
- Institute staff

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After 12 weeks, the subjectively perceived pain intensity at the most painful shoulder at study inclusion (over the last seven days) measured on a visual analog scale (VAS, 0-100 mm, 0 = no pain, 100 = worst pain imaginable)