Physiotherapist Supervised Training in Patients With Anterior Shoulder Instability

NCT06033157 | Active Not Recruiting DMC

• 1 other identifier: ASIST-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate if physiotherapist supervised training improves neuromuscular control in patients suffering from traumatic anterior shoulder instability. The main question(s) it aims to answer are:

• Does physiotherapist supervised training improve shoulder neuromuscular control
• Does physiotherapist supervised training prevent recurring shoulder dislocations
• Is physiotherapist supervised training as good as surgery in improving shoulder neuromuscular control Participants will be randomised to either a training group or a no-training group. Participants in the training group will undergo a 12 week training-program supervised by a physiotherapist. Participants in the no-training group will receive a consultation with a shoulder surgeon, where information and general advice regarding the shoulder injury is provided. Researchers will compare the training group to the no-training group to see if physiotherapist supervised training improves shoulder neuromuscular control in patients with traumatic anterior shoulder instability. The training group will also be compared to a historic group of patients with traumatic anterior shoulder instability, who underwent arthroscopic surgery.

Conditions

Shoulder Instability Subluxation Bilateral

Outcome Measures

Primary Outcomes (1)

• Neuromuscular control - Shouldersway

  \- Shoulder sway. Measured as sway-length (in millimeter).

  Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention

Secondary Outcomes (8)

• Clinical examination - Shoulder instability

  Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention

• Clinical examination - Shoulder range of motion

  Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention

• Strength measure

  Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention

• Apprehension measure

  Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention

• Patient-reported outcome measures

  Will be tested prior to intervention and 3, 6, 12 and 24 months after the beginning of the intervention

Study Arms (2)

Training

ACTIVE COMPARATOR

A 12 week physiotherapist supervised training program

Behavioral: Physiotherapist supervised training

No-training

NO INTERVENTION

A short consultation with a designated orthopedic surgeon and a folder with general advice on how to avoid further dislocations and to relieve pain from the shoulder.

Interventions

Physiotherapist supervised training BEHAVIORAL

A 12 week physiotherapist supervised training program. The patient will receive supervision by a physiotherapist 6 times during the intervention period. The patient is strongly encouraged to do the assigned training protocol at home 3 times a week. The supervised physiotherapy consists of introduction, review and progression of the assigned exercises. In addition, the patient will receive education and guidance in daily use of the arm and appropriate load on the shoulder.

Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years.
• Unilateral traumatic anterior shoulder instability.
• Willingness to adhere to the study protocol, herein attend follow-up.
• Ability to speak, read, and understand Danish.
• Ability to give written informed consent.

You may not qualify if:

• Instability in the opposite shoulder.
• Off-track lesion.
• For both shoulders: Former or planned surgery.
• For both shoulders: posterior, multi-directional or atraumatic instability.
• For both shoulders: traumatic rotator cuff or biceps tendon tear.
• For both shoulders: traumatic fracture of proximal humerus (other than Hill-Sachs lesion), clavicula, scapula (other than glenoid) or dislocation of sternoclavicular or acromioclavicular joints.
• For both shoulders: atraumatic shoulder pathologies (e.g. frozen shoulder, symptomatic osteoarthritis of the shoulder or acromioclavicular joints, acute tendinitis calcarean).
• Pregnancy.
• Terminal illness or severe medical illness: ASA score ≥3.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, Capital Region, 2650, Denmark

Location

Study Officials

• Kristine R Andreasen, MD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

• Kristoffer W Barfod, MD, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

• Kristoffer W Barfod, MD, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 13, 2023
• Study Start: November 7, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)