Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function (ROTOFUNC)

March 6, 2024 updated by: Ingrid Hultenheim Klintberg, Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early start

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

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
Experimental: Delayed start

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuromuscular control
Time Frame: Baseline One, Baseline Two (Delayed start,DS), 4 and 12 months
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.
Baseline One, Baseline Two (Delayed start,DS), 4 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical assessment - Active and passive range of motion
Time Frame: Baseline One, Baseline Two (DS), 4 and 12 months
will be assessed in standing and in lying supine in both shoulders. Flexion, abduction and external and internal rotation with shoulders at 90° abduction.
Baseline One, Baseline Two (DS), 4 and 12 months
Pain at rest
Time Frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
- during the last week will be assessed using an 11-graded numeric rating scale (NRS).
Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Patient's satisfaction
Time Frame: At 4 and 12 months

- 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
At 4 and 12 months
Pain during motion
Time Frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
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.
Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Apprehension of instability during motion
Time Frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
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.
Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Patient reported quality-of-life in relation to shoulder function
Time Frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
- 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.
Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Monika Fagevik Olsén, Professor, Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROTOFUNK_2_2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Shoulder Dislocation or Subluxation

Clinical Trials on Early Physiotherapist selected active exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe