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

Primary Purpose

Shoulder Pain

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Ambulatory rehabilitation program

About this trial

This is an interventional supportive care trial for Shoulder Pain focused on measuring Shoulder Pain, rotator cuff tendons, Ambulatory rehabilitation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Ambulatory rehabilitation program based on mobilization and muscular solicitation

Ambulatory rehabilitation program using ultrasound physiotherapy

Outcomes

Primary Outcome Measures

Shoulder Pain

algo-functional scorec SPADI, measured with Visual Analog Score

Shoulder disability

algo-functional score SPADI, measured with Visual Analog Score

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05413213

First Posted

May 2, 2022

Last Updated

June 7, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT05413213

Brief Title

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

Acronym

ERARC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

Shoulder Pain, rotator cuff tendons, Ambulatory rehabilitation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

InvestigatorOutcomes Assessor

Masking Description

The experimental plan is that of therapeutic research. This is a multicenter, prospective, comparative, randomized patient study in 2 parallel arms (ratio 1: 1) in single blind, providing for 134 participants. They can provide an unbiased evaluation of the effect of this intervention, randomisation having the effect of eliminating any influence of the patient or the doctor on the allocation of the intervention and therefore of not guiding the selection of patients according to the intervention they will receive. Conducting a double-blind trial would be impossible here. The patient and the physiotherapist will be aware of the treatment arm to which the patient belongs. However, the evaluator (who is not the therapist) will not know the treatment arm and the patient will not know the hypothesis tested (effectiveness of the rehabilitation received by the experimental group).

Allocation

Randomized

Enrollment

134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Ambulatory rehabilitation program based on mobilization and muscular solicitation

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Ambulatory rehabilitation program using ultrasound physiotherapy

Intervention Type

Procedure

Intervention Name(s)

Ambulatory rehabilitation program

Intervention Description

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

Primary Outcome Measure Information:

Title

Shoulder Pain

Description

algo-functional scorec SPADI, measured with Visual Analog Score

Time Frame

At 3 month follow-up

Title

Shoulder disability

Description

algo-functional score SPADI, measured with Visual Analog Score

Time Frame

At 3 month follow-up

Secondary Outcome Measure Information:

Title

Shoulder active mobility

Description

Time Frame

3, 6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 55 years old, Painful shoulder for at least 1 month, Shoulder treated with at least one cortisone infiltration one month or more before inclusion, Pain ≥ 40/100 on visual analog scale, Pain reproduced by at least one clinical test of rotator cuff tendons or subacromial impingement (Jobe, Patte, Neer, Yocum test, Hawkins), Full-thickness tear of at least one tendon of the rotator cuff attested by imaging, Affiliation to social security Exclusion Criteria: Passive glenohumeral mobility of the shoulder limited, Calcifying tendinopathy on standard radiography, Glenohumeral arthropathy; Painful acromioclavicular arthropathy; History of shoulder fracture; Neurogenic pain or neurogenic motor deficit of the upper limb; Cortisone infiltration of the shoulder in the month preceding inclusion; Operated shoulder; Systemic pathologies including inflammatory rheumatism or neoplastic pathology; Patient participating in another experimental research; Patient under legal protection (curators or guardianship) Patient deprived of liberty by a judicial or administrative decision Pregnant or breastfeeding woman

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

BEAUDREUIL Johann, Pr

Phone

01 49 95 63 08

Ext

00 33

johann.beaudreuil@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

BEAUDREUIL Johann, Pr

Organizational Affiliation

Lariboisière Hospital -physical medicine and rehabilitation department

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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