RecruitingNot ApplicableNCT06261645

Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function

ROTOFUNC - a Randomized and Controlled Study to Evaluate the Effect of a Novel Assessment and Treatment Strategy for Patients With Non-traumatic Shoulder Instability


Sponsor

Sahlgrenska University Hospital

Enrollment

100 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition.


Eligibility

Min Age: 16 YearsMax Age: 35 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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

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Interventions

OTHEREarly Physiotherapist selected active exercises

Exercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance. Education on shoulder muscles functional anatomy and on effect of pain on muscle performance

OTHERDelayed Physiotherapist selected active exercises

Exercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance. Education on shoulder muscles functional anatomy and on effect of pain on muscle performance


Locations(1)

Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt

Gothenburg, Mölndal, Sweden

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NCT06261645


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