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

NCT05413213 | Unknown

• 1 other identifier: APHP200070
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Pain

Keywords

Shoulder Pain; rotator cuff tendons; Ambulatory rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Shoulder active mobility

  3, 6, 12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Ambulatory rehabilitation program based on mobilization and muscular solicitation

Procedure: Ambulatory rehabilitation program

Control Group

ACTIVE COMPARATOR

Ambulatory rehabilitation program using ultrasound physiotherapy

Procedure: Ambulatory rehabilitation program

Interventions

Ambulatory rehabilitation program PROCEDURE

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 55 years old,
• Painful shoulder for at least 1 month,
• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• BEAUDREUIL Johann, Pr

  Lariboisière Hospital -physical medicine and rehabilitation department

  STUDY CHAIR

Central Study Contacts

BEAUDREUIL Johann, Pr

CONTACT

01 49 95 63 08; johann.beaudreuil@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: June 9, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2024
• Last Updated: June 9, 2022

Record last verified: 2022-04