An interventional study of Early Physiotherapist selected active exercises and Delayed Physiotherapist selected active exercises in Shoulder Dislocation or Subluxation, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment
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.
Impaired shoulder function and pain results in decreased quality-of-life, reduced working capacity and affect both society and individuals with high costs. Young adults with non-traumatic shoulder instability are one of the most difficult patient groups to treat. Surgery has previously been the treatment offered for these patients. Today, surgery is more and more questioned and physiotherapy and now active exercises are suggested to be the first - line of treatment.
A novel physiotherapy treatment strategy has been developed during the recent years.
The intervention is based on an entirely updated mode to assess and restore shoulder muscle function. The development has been initiated by new data from EMG- studies that has given a deepened understanding of the complex stabilizing muscle function of the shoulder. The hypothesis is that the main stabilizing muscles, the rotator cuff has by franc dislocations, subluxations and pain lost its rapidness, precision, and endurance to keep the humeral head stabilized and centered within the glenoid fossa.
The hypothesis is that with restored, full rotator cuff function, i. e. a rotator cuff able to perform its stabilizing role and the mover role into the extremes of the range of motion, where the fibers act from their most shortened to their most lengthened positions and during concentric as well as eccentric muscle action, will regain the sense of shoulder stability, pain-free shoulder function and higher quality-of-life.
The purpose of this study is to evaluate the effect of this new active exercise-based intervention in patients with non-traumatic shoulder instability.
Methods: A total of 100 patients randomly be allocated into two different groups, Early start and Delayed start. Both groups will receive the same 16-week physiotherapy supervised exercise program, however the latter group with a delay of four months.
The primary outcome is assessment of neuromuscular control during active rotation movements documented with video. The range of motion is measured, and sway and steadiness are graded. The secondary outcomes include: 1) active and passive range of motion; 2) shoulder pain at rest using an 11-graded numeric rating scale; 3) Pain during motion, and 4) Apprehension during motion using Patient Specific Functional Scale; 5) Quality-of-life will be assessed using Western Ontario Shoulder Instability Index (WOSI) Patients will be assessed by one of two independent investigators at baseline (second baseline if Delayed Start), 6 weeks, 4 and 12 months. At 4 and 12 months also Patient's Satisfaction of being treated with the novel strategy will be assessed.
The statistical analysis will assess change over time and differences between groups using ANOVA and Tukey's PostHoc-test as well as Kruskal- Wallis and Mann-Whitney-U test with the significant level was set at 0.05.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
According to result from the random allocation patients in Early Start will initiate their treatment within two weeks following the Baseline assessment.The intervention consists of a 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily. According to progression, a mean of 10 visits are anticipated over the 16 weeks In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder.
Other: Early Physiotherapist selected active exercises
According to result from the random allocation patients in Delayed Start will delay the start of their treatment with 16 weeks. Participants in Delayed Start will undergo the same Baseline assessment a second time, and initiate their treatment within 2 weeks thereafter. The intervention consists of a 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily. According to progression, a mean of 10 visits are anticipated over the 16 weeks In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder.
Other: Delayed 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
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
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
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
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
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
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
Patient reported quality-of-life in relation to shoulder function
- will be assessed using Western Ontario Shoulder Instability Index \[9\]. The questionnaire consists of 21 items. Patients rate their percieved function for each item using Visual Analogue Scales, 0 - 100 mm, with a lower score indicating better function. The result of the total score is presented in percentage of full (100%) shoulder function i.e. perceived quality of life using related to shoulder function. Higher percent indicates better function.
Time frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Patient's satisfaction
- of being treated according to the novel concept will be assessed using a five-graded Likert scale: Very dissatisfied; Dissatisfied; neither dissatisfied nor satisfied; Satisfied and Very satisfied. As well as: Would you recommend this treatment concept to a friend or relative with similar shoulder dysfunction as yours?, will be assessed using the three response options: Yes, No, or Do not know
Time frame: At 4 and 12 months
Started May 2023 (actual). Primary completion is estimated for Dec 2025, 31 months after the start.
Of 39 non-industry interventional studies with no phase under Shoulder Dislocation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 31 months is above that.
Counting every sponsor, half of 39 studies reached it within 22 months; a quarter within 11 and three quarters within 39.
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