Shoulder DislocationNCT05767957
Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension
A study testing Rehabilitation physiotherapy and Cognitive-behavioral therapies in addition to rehabilitation physiotherapy in people with Shoulder Dislocation and Shoulder Instability, run by Centre Epaule Coude CEPCO at 2 sites in Switzerland.
Trial summary
Randomized controlled double-blind study aimed at studying the contribution of cognitive-behavioral therapy in the treatment of shoulder apprehension. Comparison of 2 physiotherapy techniques in the context of shoulder instability. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Shoulder Dislocation, Shoulder Instability
- What is being tested?
- Rehabilitation physiotherapy and Cognitive-behavioral therapies in addition to rehabilitation physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- positive apprehension test;
- traumatic anterior dislocation of the glenohumeral joint requiring or not surgical stabilization according to Bankart or Latarjet;
- good oral and written comprehension of French;
- age between 15 and 45 years old.
Who cannot join
- associated tendon injury requiring surgical treatment;
- fracture other than Bankart fracture;
- multidirectional instability (MDI);
- peripheral neurological lesion in the upper limb;
- central neurological lesion;
- diagnosed psychosis, depression or epilepsy.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
Centre Epaule Coude CEPCO
Geneva, 1206
Benoît Borner, +41 79 430 17 26, benoit.borner@bluewin.ch
Benoît Borner
- Recruiting
Hôpital La Tour
Meyrin, 1217
Benoît Borner, +41 79 430 17 26, benoit.borner@bluewin.ch
Alexandre Laedermann
About this study
Official title: The Contribution Of Cognitivo-Behavorial Therapy In Treatment Of Shoulder Apprehension: A Randomized Clinical Study
Randomized controlled double-blind study aimed at studying the contribution of cognitive-behavioral therapy in the treatment of shoulder apprehension. Comparison of 2 physiotherapy techniques in the context of shoulder instability.
Control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone.
Intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.
Read the detailed description
Traumatic anterior instability of the shoulder is one of the most frequent lesions of the shoulder, the majority of cases of which occur in adolescents, with a risk of recurrence close to 90% if it occurs before the age of 20 years. It can be treated conservatively or surgically. Stabilizing surgery of the glenohumeral joint offers satisfactory results for people suffering from shoulder instability. Like subjects treated conservatively, patients undergoing stabilizing surgery remain apprehensive after the operation in 2 to 51% of cases. Currently, no rehabilitation program has demonstrated superior effectiveness, during instability treated conservatively or during postoperative rehabilitation. Recent studies have shown that cortical reorganization takes place, especially in areas of fear and anxiety. Faced with the need to develop physiotherapeutic management in post-traumatic unstable shoulder, this study aims to evaluate the contribution of cognitive-behavioral therapy, by including a neuropsychological axis in the rehabilitation of patients.
This study is randomized and controlled, multicenter, including 144 patients suffering from apprehension of the shoulder, divided into two treatment groups. Both groups will receive a conventional physiotherapy protocol including individual sessions and home exercises. The physiotherapists in the intervention group will also have received training in the use of techniques from Cognitive-Behavioral Therapies. Data will be collected before the introduction of physiotherapy, after 6, 12, 24 and 52 weeks of treatment. In the event of surgery, the data will also be collected preoperatively. The primary outcome is apprehension measured by the Rowe score. The secondary outcomes are apprehension measured by the apprehension and relocation tests, and the Tampa Scale for Kinesiophobia, as well as shoulder function, measured by the Simple Shoulder Test and the Subjective Shoulder Value.
- Conditions
- Shoulder Dislocation, Shoulder Instability
- Being tested
- Rehabilitation physiotherapy, Cognitive-behavioral therapies in addition to rehabilitation physiotherapy
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation physiotherapyOther
Rehabilitation physiotherapy by physiotherapist using conventional technique alone.
Cognitive-behavioral therapies in addition to rehabilitation physiotherapyOther
Rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Rehabilitation physiotherapy |
| Intervention group | Experimental | Not described Receives: Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rowe score
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Measured: enrolment
Rowe score
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Measured: 6 weeks
Rowe score
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Measured: 3 months
Rowe score
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Measured: 6 months
Rowe score
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Measured: 12 months
Secondary outcomes (40)
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: enrolment
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: 3 months
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: 6 months
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: 12 months
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: enrolment
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: 3 months
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: 6 months
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Measured: 12 months
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Measured: enrolment
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Measured: 3 months
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Measured: 6 months
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Measured: 12 months
Shoulder Range Of Motion: internal rotation
unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6)
Measured: enrolment
Shoulder Range Of Motion: internal rotation
unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6)
Measured: 3 months
Shoulder Range Of Motion: internal rotation
unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6)
Measured: 6 months
Shoulder Range Of Motion: internal rotation
unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6)
Measured: 12 months
Rotator cuff strength: anterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: enrolment
Rotator cuff strength: anterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 3 months
Rotator cuff strength: anterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 6 months
Rotator cuff strength: anterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 12 months
Rotator cuff strength: superior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: enrolment
Rotator cuff strength: superior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 3 months
Rotator cuff strength: superior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 6 months
Rotator cuff strength: superior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 12 months
Rotator cuff strength: posterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: enrolment
Rotator cuff strength: posterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 3 months
Rotator cuff strength: posterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 6 months
Rotator cuff strength: posterior cuff
scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength)
Measured: 12 months
Apprehension test
examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4)
Measured: enrolment
Apprehension test
examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4)
Measured: 3 months
Apprehension test
examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4)
Measured: 6 months
Apprehension test
examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4)
Measured: 12 months
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Measured: enrolment
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Measured: 3 months
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Measured: 6 months
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Measured: 12 months
Relocation test
positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied
Measured: enrolment
Relocation test
positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied
Measured: 3 months
Relocation test
positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied
Measured: 6 months
Relocation test
positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Jan 2022
- Primary completion31 Jan 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone. Intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Epaule Coude CEPCO
- Sponsor type
- University, hospital or other
- Collaborators
- Gregory Cunningham, Alexandre Laedermann, Benoît Borner, Yannick Thilby, Suzanne Gard
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767957
- Sponsor's protocol ID
- 2021-01912
- Status last verified
- Mar 2023
- First submitted
- 25 Jul 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution Of Cognitivo-Behavorial Therapy In Treatment Of Shoulder Apprehension: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05767957
- Acronym / sponsor ID
- 2021-01912
- Conditions
- Shoulder Dislocation, Shoulder Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Centre Epaule Coude CEPCOUniversity, hospital or other
- Collaborators
- Gregory Cunningham, Alexandre Laedermann, Benoît Borner, Yannick Thilby, Suzanne Gard
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled double-blind study aimed at studying the contribution of cognitive-behavioral therapy in the treatment of shoulder apprehension. Comparison of 2 physiotherapy techniques in the context of shoulder instability.
Control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone.
Intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.
Detailed description
Traumatic anterior instability of the shoulder is one of the most frequent lesions of the shoulder, the majority of cases of which occur in adolescents, with a risk of recurrence close to 90% if it occurs before the age of 20 years. It can be treated conservatively or surgically. Stabilizing surgery of the glenohumeral joint offers satisfactory results for people suffering from shoulder instability. Like subjects treated conservatively, patients undergoing stabilizing surgery remain apprehensive after the operation in 2 to 51% of cases. Currently, no rehabilitation program has demonstrated superior effectiveness, during instability treated conservatively or during postoperative rehabilitation. Recent studies have shown that cortical reorganization takes place, especially in areas of fear and anxiety. Faced with the need to develop physiotherapeutic management in post-traumatic unstable shoulder, this study aims to evaluate the contribution of cognitive-behavioral therapy, by including a neuropsychological axis in the rehabilitation of patients.
This study is randomized and controlled, multicenter, including 144 patients suffering from apprehension of the shoulder, divided into two treatment groups. Both groups will receive a conventional physiotherapy protocol including individual sessions and home exercises. The physiotherapists in the intervention group will also have received training in the use of techniques from Cognitive-Behavioral Therapies. Data will be collected before the introduction of physiotherapy, after 6, 12, 24 and 52 weeks of treatment. In the event of surgery, the data will also be collected preoperatively. The primary outcome is apprehension measured by the Rowe score. The secondary outcomes are apprehension measured by the apprehension and relocation tests, and the Tampa Scale for Kinesiophobia, as well as shoulder function, measured by the Simple Shoulder Test and the Subjective Shoulder Value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone. Intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Rehabilitation physiotherapy |
| Intervention group | Experimental | Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- positive apprehension test;
- traumatic anterior dislocation of the glenohumeral joint requiring or not surgical stabilization according to Bankart or Latarjet;
- good oral and written comprehension of French;
- age between 15 and 45 years old.
Key exclusion criteria (6 listed)
- associated tendon injury requiring surgical treatment;
- fracture other than Bankart fracture;
- multidirectional instability (MDI);
- peripheral neurological lesion in the upper limb;
- central neurological lesion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation physiotherapyRehabilitation physiotherapy by physiotherapist using conventional technique alone. | Other | Control group |
| Cognitive-behavioral therapies in addition to rehabilitation physiotherapyRehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies. | Other | Intervention group |
Primary outcome
Rowe score
Time frame: enrolment
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Rowe score
Time frame: 6 weeks
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Rowe score
Time frame: 3 months
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Rowe score
Time frame: 6 months
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
Rowe score
Time frame: 12 months
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)
40 secondary outcomes
Shoulder Range Of Motion: flexion
Time frame: enrolment
Shoulder Range Of Motion: flexion
Time frame: 3 months
Shoulder Range Of Motion: flexion
Time frame: 6 months
Shoulder Range Of Motion: flexion
Time frame: 12 months
Shoulder Range Of Motion: abduction
Time frame: enrolment
Shoulder Range Of Motion: abduction
Time frame: 3 months
Shoulder Range Of Motion: abduction
Time frame: 6 months
Shoulder Range Of Motion: abduction
Time frame: 12 months
Shoulder Range Of Motion: external rotation
Time frame: enrolment
Shoulder Range Of Motion: external rotation
Time frame: 3 months
Shoulder Range Of Motion: external rotation
Time frame: 6 months
Shoulder Range Of Motion: external rotation
Time frame: 12 months
Shoulder Range Of Motion: internal rotation
Time frame: enrolment
Shoulder Range Of Motion: internal rotation
Time frame: 3 months
Shoulder Range Of Motion: internal rotation
Time frame: 6 months
Shoulder Range Of Motion: internal rotation
Time frame: 12 months
Rotator cuff strength: anterior cuff
Time frame: enrolment
Rotator cuff strength: anterior cuff
Time frame: 3 months
Rotator cuff strength: anterior cuff
Time frame: 6 months
Rotator cuff strength: anterior cuff
Time frame: 12 months
Rotator cuff strength: superior cuff
Time frame: enrolment
Rotator cuff strength: superior cuff
Time frame: 3 months
Rotator cuff strength: superior cuff
Time frame: 6 months
Rotator cuff strength: superior cuff
Time frame: 12 months
Rotator cuff strength: posterior cuff
Time frame: enrolment
Rotator cuff strength: posterior cuff
Time frame: 3 months
Rotator cuff strength: posterior cuff
Time frame: 6 months
Rotator cuff strength: posterior cuff
Time frame: 12 months
Apprehension test
Time frame: enrolment
Apprehension test
Time frame: 3 months
Apprehension test
Time frame: 6 months
Apprehension test
Time frame: 12 months
Subjective apprehension
Time frame: enrolment
Subjective apprehension
Time frame: 3 months
Subjective apprehension
Time frame: 6 months
Subjective apprehension
Time frame: 12 months
Relocation test
Time frame: enrolment
Relocation test
Time frame: 3 months
Relocation test
Time frame: 6 months
Relocation test
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Shoulder Dislocation
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
RecruitingObservational study
Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years
Anterior Glenohumeral Dislocations
Not yet recruiting
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.
Shoulder Dislocation
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation physiotherapy and Cognitive-behavioral therapies in addition to rehabilitation physiotherapy in people with Shoulder Dislocation and Shoulder Instability, run by Centre Epaule Coude CEPCO at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rowe score (time frame: enrolment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.