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Effectiveness of osteopathic medicine in patients with chronic subacromial impingement syndrome – A two-arm, randomized controlled, open-label, multicenter study

Effectiveness of osteopathic medicine in patients with chronic subacromial impingement syndrome – A two-arm, randomized controlled, open-label, multicenter study - Osteopathic medicine in impingement syndrom (OMIS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038817
Enrollment
150
Registered
2025-12-23
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M75.4

Interventions

Group 1: 5 osteopathic treatments at 2-week intervals +usual care Group 2: Usual care Patients receive the usual conventional medical treatment for this condition, which is commonly referred to as “us

Sponsors

Akademie für Osteopathie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - Clinical diagnosis of chronic shoulder pain (duration of illness at least 12 weeks) with clinical signs of SIS (positive test for subacromial painful arc, Neer test, and Hawkins impingement test (Hawkins/Kennedy) on the shoulder with the most severe pain - Subjectively perceived pain intensity in the most painful shoulder within seven days of at least 40 mm on a VAS (0-100 mm, 0 = no pain, 100 = worst pain imaginable) - Willingness to refrain from other osteopathic treatment during the study period. - Capacity to give consent - Consent (in paper form) has been obtained

Exclusion criteria

Exclusion criteria: - Pain in the most painful shoulder that is not caused by SIS and/or requires urgent conventional medical treatment (e.g., malignant disease, recent trauma, SLAP (superior labrum anterior posterior lesion), evidence of a structural lesion of the rotator cuff) - Peripheral and/or central neurological symptoms (e.g., radiculopathy, amyotrophic lateral sclerosis, stroke) - Rheumatic diseases (e.g., rheumatoid arthritis) - Shoulder surgery on the most painful shoulder within the last 6 months, or surgery on the shoulders or spine planned within the next 12 weeks - Generalized pain disorder (e.g., fibromyalgia) - Treatment of shoulder complaints (both sides) with manual medicine - 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 to undergo OM - Use of centrally acting analgesics (e.g., opiates) - Treatment with OM within the last 6 months prior to the start of the study - Expected lack of compliance with regard to study participation (e.g., stating that they do not wish to answer any further questions; limited general compliance ability in cases of dementia, severe alcohol abuse, drug abuse) - Insufficient knowledge of the German language - Participation in other studies - No email address available - No ability or opportunity to operate or use smartphones or tablets independently

Design outcomes

Primary

MeasureTime frame
Subjectively perceived maximum pain intensity in the shoulder that was most painful at the start of the study (over the last seven days) measured on a VAS (0-100 mm, 0 = no pain, 100 = worst pain imaginable) at 12 weeks after baseline and 3 months after the end of the study (follow-up)

Secondary

MeasureTime frame
- Duration of pain in the shoulder that was most painful at the start of the study (over the last seven days) on a Likert scale (0-4) - Shoulder function using the DASH score - Subjective psychological well-being using the World Health Organization Five Wellbeing Index (WHO-5) - Days of incapacity for work due to chronic shoulder pain in SIS - Medication

Countries

Germany

Contacts

Public ContactFlorian Schwerla

Akademie für Osteopathie

f.schwerla@german-afo.de+49 89 893 400 68

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026