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

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Shoulder Pain

Treatments

Procedure: Ambulatory rehabilitation program

Study type

Interventional

Funder types

Other

Identifiers

NCT05413213
APHP200070

Details and patient eligibility

About

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.

Full 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

Enrollment

134 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

134 participants in 2 patient groups

Experimental Group
Experimental group
Description:
Ambulatory rehabilitation program based on mobilization and muscular solicitation
Treatment:
Procedure: Ambulatory rehabilitation program
Control Group
Active Comparator group
Description:
Ambulatory rehabilitation program using ultrasound physiotherapy
Treatment:
Procedure: Ambulatory rehabilitation program

Trial contacts and locations

0

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Central trial contact

BEAUDREUIL Johann, Pr

Data sourced from clinicaltrials.gov

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