CClinicalTrials.gg
Status unknownNCT05413213ERARCUpdated Jun 9, 2022

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

An interventional study of Ambulatory rehabilitation program in Shoulder Pain, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Shoulder Pain

Keywords

  • Shoulder Pain
  • rotator cuff tendons
  • Ambulatory rehabilitation
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's planned enrollment of 134 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    Ambulatory rehabilitation program based on mobilization and muscular solicitation

    Procedure: Ambulatory rehabilitation program

  • Active comparator
    Control Group

    Ambulatory rehabilitation program using ultrasound physiotherapy

    Procedure: Ambulatory rehabilitation program

Interventions

  • ProcedureAmbulatory rehabilitation program

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

06

What researchers measure

Primary outcomes

  1. Shoulder Pain

    algo-functional scorec SPADI, measured with Visual Analog Score

    Time frame: At 3 month follow-up

  2. Shoulder disability

    algo-functional score SPADI, measured with Visual Analog Score

    Time frame: At 3 month follow-up

Secondary outcomes

  1. 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

    Time frame: 3, 6, 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05413213
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 9, 2022
Start date
Sep 2022 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jun 9, 2022

Study contacts

BEAUDREUIL Johann, Pr
Contact
johann.beaudreuil@aphp.fr
01 49 95 63 08 ext. 00 33
BEAUDREUIL Johann, Pr
study chair · Lariboisière Hospital -physical medicine and rehabilitation department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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