Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01544244
Other study ID # PHRIP/2011/DR-03
Secondary ID 2011-A01168-33
Status Terminated
Phase N/A
First received February 23, 2012
Last updated June 2, 2016
Start date October 2012
Est. completion date May 2016

Study information

Verified date June 2016
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to demonstrate the superiority of the CGE physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the FI2S score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.


Description:

Secondary objectives:

- To study the evolution of passive glenohumeral range of motion

- To study the evolution of the global range of passive and active motion for each method used

- To evaluate functional recovery (DASH)

- To evaluate the impact on quality of life (SF36)

- To study the difference in visual analog scale scores for pain during physical therapy sessions

- Compare the two methods/groups after three months.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- The patient must have given his/her informed and signed consent

- The patient must be insured or beneficiary of a health insurance plan

- painful, chronic tendinopathy (more than 3 months) of the rotator cuff, confirmed by MRI

Exclusion Criteria:

- The patient is pregnant or breastfeeding

- Any emergency situation

- Non-mechanical tendinopathies (metabolic, neurological, capsulitis, reflex sympathetic dystrophy) and tendon surgery (tendon surgery and acromioplasty)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
GSC physical therapy
Global Shoulder Concept physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.
Standard physical therapy
Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.

Locations

Country Name City State
France CHU de Montpellier - Hôpital Lapeyronie Montpellier
France CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 9

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in FI2S score 90 days No
Secondary Change in visual analog scale for pain Day 1 versus baseline Yes
Secondary Change in visual analog scale for pain Day 5 versus baseline Yes
Secondary Change in visual analog scale for pain Day 12 versus baseline Yes
Secondary Change in visual analog scale for pain Day 19 versus baseline Yes
Secondary Change in visual analog scale for pain Day 26 versus baseline Yes
Secondary Change in visual analog scale for pain Day 90 versus baseline Yes
Secondary Scapulohumeral amplitude gain in 3 main directions Passive and active mobility are evaluated by manual goniometry. Day 1 No
Secondary Scapulohumeral amplitude gain in 3 main directions Passive and active mobility are evaluated by manual goniometry. Day 26 No
Secondary Scapulohumeral amplitude gain in 3 main directions Passive and active mobility are evaluated by manual goniometry. Day 90 No
Secondary Functional gain as measured by the DASH self questionnaire Day 1 No
Secondary Functional gain as measured by the DASH self questionnaire Day 5 No
Secondary Functional gain as measured by the DASH self questionnaire Day 12 No
Secondary Functional gain as measured by the DASH self questionnaire Day 19 No
Secondary Functional gain as measured by the DASH self questionnaire Day 26 No
Secondary Functional gain as measured by the DASH self questionnaire Day 90 No
Secondary FI2S score Day 1 No
Secondary FI2S score Day 5 No
Secondary FI2S score Day 12 No
Secondary FI2S score Day 19 No
Secondary FI2S score Day 26 No
Secondary SF36 self questionnaire Day 1 No
Secondary SF36 self questionnaire Day 26 No
Secondary SF36 self questionnaire Day 90 No
See also
  Status Clinical Trial Phase
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT03307499 - NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery N/A
Completed NCT02499484 - Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy N/A
Completed NCT01944150 - Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis N/A
Recruiting NCT04578418 - Effect of Collagen Supplementation on Tendinopathy N/A
Completed NCT03262181 - The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy N/A
Completed NCT03502434 - A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers Phase 1
Recruiting NCT04278833 - Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions Phase 4
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Recruiting NCT05603468 - Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair Phase 4
Not yet recruiting NCT06056440 - Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab) N/A
Recruiting NCT04144946 - Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
Terminated NCT02978833 - Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy Phase 4
Completed NCT03229291 - A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects Phase 1
Recruiting NCT04058509 - Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain N/A
Withdrawn NCT02981394 - Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Active, not recruiting NCT02600910 - Natural History of Shoulder Pathology in Manual Wheelchair Users
Completed NCT04793971 - Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
Not yet recruiting NCT01225497 - Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy N/A
Completed NCT04067479 - Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise N/A