Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder

Not Applicable

Not yet recruiting

• Conditions: Shoulder Pain
• Interventions: Procedure: Ambulatory rehabilitation program

• Registration Number: NCT05413213
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The main objective of the research is to study the effectiveness of an ambulatory rehabilitation program based on mobilization and muscular solicitation, during painful shoulders by full-thickness degenerative rupture of the tendons of the rotator cuff. , with the algo-functional state, ie pain and activity limitation, as judgment criteria, at 3 months.

Detailed Description

Our hypothesis is that rehabilitation based on mobilization and muscular solicitation is effective in painful shoulder due to degenerative rupture of the tendons of the rotator cuff; that it reduces pain, functional limitation and the need for surgery.

Research Excluding health products:

Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation

Control group: Ambulatory rehabilitation program using of ultrasound physiotherapy

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Study First Posted: 2022-06-09
• Last Update Posted: 2022-06-09
• Study Start: 2022-09
• Primary Completion: 2022-12
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Age ≥ 55 years old,
2. Painful shoulder for at least 1 month,
3. Shoulder treated with at least one cortisone infiltration one month or more before inclusion,
4. Pain ≥ 40/100 on visual analog scale,
5. Pain reproduced by at least one clinical test of rotator cuff tendons or subacromial impingement (Jobe, Patte, Neer, Yocum test, Hawkins),
6. Full-thickness tear of at least one tendon of the rotator cuff attested by imaging,
7. Affiliation to social security

Exclusion Criteria

1. Passive glenohumeral mobility of the shoulder limited,
2. Calcifying tendinopathy on standard radiography,
3. Glenohumeral arthropathy;
4. Painful acromioclavicular arthropathy;
5. History of shoulder fracture;
6. Neurogenic pain or neurogenic motor deficit of the upper limb;
7. Cortisone infiltration of the shoulder in the month preceding inclusion;
8. Operated shoulder;
9. Systemic pathologies including inflammatory rheumatism or neoplastic pathology;
10. Patient participating in another experimental research;
11. Patient under legal protection (curators or guardianship)
12. Patient deprived of liberty by a judicial or administrative decision
13. Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Ambulatory rehabilitation program	Ambulatory rehabilitation program using ultrasound physiotherapy
Experimental Group	Ambulatory rehabilitation program	Ambulatory rehabilitation program based on mobilization and muscular solicitation

Primary Outcome Measures

Name	Time	Method
Shoulder Pain	At 3 month follow-up	algo-functional scorec SPADI, measured with Visual Analog Score
Shoulder disability	At 3 month follow-up	algo-functional score SPADI, measured with Visual Analog Score

Secondary Outcome Measures

Name	Time	Method
Shoulder active mobility	3, 6, 12 months	Pain subscore of the SPADI scale; Abduction strength by dynamometer, Activity limitation by the function subscore of the SPADI scale , Life quality Overall improvement perceived by the patient by the 5-point Likert scale, at 3 months, 6 months and 1 year; The total algo-functional score of the SPADI scale at 6 months and 1 year; The use of non-surgical care, Assessed by drug consumption, the number of cortisone infiltrations, The number of non-protocol rehabilitation sessions and the number of consultations outside the scope of the study; The use of surgery for degenerative rupture of the tendons of the rotator cuff by the number of surgical interventions and the Type of surgery performed in this indication during follow-up, The time off work by the number of days