Treatment for non-traumatic shoulder instability in young adults
ROTOFUNC - a Randomized and Controlled Study to Evaluate the Effect of a Novel Assessment and Treatment Strategy for Patients With Non-traumatic Shoulder Instability
This study is testing a new exercise program for young adults with shoulder instability to see if it can help them feel better and improve their daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 1 site (Gothenburg, Mölndal) |
| Trial ID | NCT06261645 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a novel physiotherapy treatment strategy for young adults suffering from severely disabling non-traumatic shoulder instability. Participants will undergo a personalized exercise regimen designed to restore shoulder muscle function and stability over a four-month period. The study will compare outcomes between two groups: one receiving immediate treatment and another experiencing a four-month delay before starting the intervention. The goal is to improve shoulder function and quality of life by enhancing the dynamic stability of the shoulder through targeted exercises.
Who should consider this trial
Good fit: Ideal candidates for this study are young adults with non-traumatic, positional, or functional shoulder instability who demonstrate a lack of active dynamic control.
Not a fit: Patients with other significant shoulder pathologies or those with severe systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve shoulder function and quality of life for patients with non-traumatic shoulder instability.
How similar studies have performed: While this approach is innovative, previous studies have suggested that physiotherapy can be effective for shoulder instability, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * young adults, non traumatic as well as non-controllable, positional, functional shoulder instability according to Moroder et al. demonstrating a lack of ≥ 20%, active, dynamic control compared with the total passive range of motion in shoulder rotation with or without previous shoulder stabilizing surgery * Understanding the Swedish language well, in speaking, in reading and writing. Exclusion Criteria: * Other significant shoulder pathologies, patients diagnosed with severe systemic connective tissue, congenital anatomic abnormalities, or psychiatric diagnoses according to previous medical records * \<60% adherence to assigned exercises
Where this trial is running
Gothenburg, Mölndal
- Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt — Gothenburg, Mölndal, Sweden (Recruiting)
Study contacts
- Principal investigator: Monika Fagevik Olsén, Professor — Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy
- Study coordinator: Ingrid K Hultenheim Klinberg, PhD
- Email: ingrid.hultenheim-klintberg@vgregion.se
- Phone: +46313430503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.