NCT05767957

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

July 25, 2022

Last Update Submit

March 12, 2023

Conditions

Shoulder DislocationShoulder Instability

Outcome Measures

Primary Outcomes (5)

  • Rowe score

    Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: \<50 pts)

    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)

    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)

    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)

    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)

    12 months

Secondary Outcomes (40)

  • Shoulder Range Of Motion: flexion

    enrolment

  • Shoulder Range Of Motion: flexion

    3 months

  • Shoulder Range Of Motion: flexion

    6 months

  • Shoulder Range Of Motion: flexion

    12 months

  • Shoulder Range Of Motion: abduction

    enrolment

  • +35 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR
Other: Rehabilitation physiotherapy

Intervention group

EXPERIMENTAL
Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy

Interventions

Rehabilitation physiotherapyOTHER

Rehabilitation physiotherapy by physiotherapist using conventional technique alone.

Control group
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.

Intervention group

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Epaule Coude CEPCO

Geneva, 1206, Switzerland

RECRUITING

Hôpital La Tour

Meyrin, 1217, Switzerland

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

March 14, 2023

Study Start

January 1, 2022

Primary Completion

January 31, 2022

Study Completion

December 31, 2024

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)