Clinical trial NCT05413213: Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder
Official title: Efficiency of an Ambulatory Rehabilitation Program in Patients With Shoulder Degenerative Rupture of the Rotator Cuff Tendons
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Keywords: Shoulder Pain
rotator cuff tendons
Ambulatory rehabilitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 134
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: Ambulatory rehabilitation program based on mobilizations and muscular solicitations (muscle strengthening and dynamic humeral recentering), supervised by a physiotherapist, consisting of 15 individual sessions of 30 minutes each, spread over 8 weeks, according to a standardized program .

Control group: Ambulatoryrehabilitation program, consisting of ultrasound physiotherapy, supervised by a physiotherapist, consisting of 15 individual sessions of 30 minutes each, spread over 8 weeks.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder Pain
timeFrame: At 3 month follow-up
measure: Shoulder disability
timeFrame: At 3 month follow-up
Secondary outcomes:
measure: Shoulder active mobility
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Lariboisière Hospital -physical medicine and rehabilitation department
name: BEAUDREUIL Johann, Pr
role: STUDY_CHAIR
References: