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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Pain
• Intervention / Treatment: Procedure: Ambulatory rehabilitation program

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 Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BEAUDREUIL Johann, Pr; Phone Number: 00 33 01 49 95 63 08; Email: johann.beaudreuil@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Ambulatory rehabilitation program based on mobilization and muscular solicitation	Procedure: Ambulatory rehabilitation program; Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation.
Active Comparator: Control Group; Ambulatory rehabilitation program using ultrasound physiotherapy	Procedure: Ambulatory rehabilitation program; Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain	algo-functional scorec SPADI, measured with Visual Analog Score	At 3 month follow-up
Shoulder disability	algo-functional score SPADI, measured with Visual Analog Score	At 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: BEAUDREUIL Johann, Pr, Lariboisière Hospital -physical medicine and rehabilitation department

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Shoulder Pain; rotator cuff tendons; Ambulatory rehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Rupture; Shoulder Pain
• Other Study ID Numbers: APHP200070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No