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

Shoulder Pain Clinical Trial

— ERARC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05413213
• Other study ID #: APHP200070
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: BEAUDREUIL Johann, Pr
• Phone: 01 49 95 63 08
• Email: johann.beaudreuil[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: September 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rupture
• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain	algo-functional scorec SPADI, measured with Visual Analog Score	At 3 month follow-up
Primary	Shoulder disability	algo-functional score SPADI, measured with Visual Analog Score	At 3 month follow-up
Secondary	Shoulder active mobility	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	3, 6, 12 months