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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-35
SponsorSahlgrenska University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Early Physiotherapist selected active exercises

    Other intervention

    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

  • Delayed Physiotherapist selected active exercises

    Other intervention

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Early startExperimental treatment 1 intervention
Group B: Delayed startExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neuromuscular control

Available range of motion during shoulder rotation during 8 different test situations, in prone and in supine with support and without support for the upper arm (degrees). The performance, sway and halting during motion, will be graded using a Likert scale: no deviation, small deviation, medium- or important deviation from optimal non-symptomatic shoulder function.

Time frame
Baseline One, Baseline Two (Delayed start,DS), 4 and 12 months

Secondary outcomes

1

Clinical assessment - Active and passive range of motion

will be assessed in standing and in lying supine in both shoulders. Flexion, abduction and external and internal rotation with shoulders at 90° abduction.

Time frame
Baseline One, Baseline Two (DS), 4 and 12 months
2

Pain at rest

\- during the last week will be assessed using an 11-graded numeric rating scale (NRS).

Time frame
Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
3

Pain during motion

Four activities that affect the patients every-day life will be selected and assessed using Patient Specific Functional scale, each graded 0 -10, with a higher score indicating higher, better function.

Time frame
Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
4

Apprehension of instability during motion

Four activities that affects the patients every-day life by discomfort and apprehension will be selected and assessed using Patient Specific Functional scale, each graded 0 -10, with a higher score indicating higher, better function.

Time frame
Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months

Other outcomes

Sponsors and contacts

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