Trials / Unknown
UnknownNCT05478902
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- Sponsor
- University of Valencia · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.
Detailed description
Rotator cuff calcific tendinopathy (RCCT) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. Conservative interventions such as extracorporeal shockwave therapy (ESWT) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) have been commonly recommended as part of the early management for this clinical condition. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with RCCT yet. A randomised, single-blinded four parallel group clinical trial will be conducted. Participants (n=116) will be randomised in four groups: (1) ET; (2) ESWT; (3) US-PICT or (4) control.
Conditions
- Rotator Cuff Tendinosis
- Rotator Cuff Injuries
- Shoulder Tendinitis
- Calcific Shoulder Tendinitis
- Calcification Tendon
- Calcific Tendinitis
- Shoulder Pain
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Exercise Therapy | Exercise protocol for rotator cuff related shoulder pain |
| PROCEDURE | Extracorporeal Shockwave Therapy | High Energy Extracorporeal Shockwave Therapy |
| PROCEDURE | Ultrasound-Guided Percutaneous Irrigation | Two sessions of Ultrasound-Guided Percutaneous Irrigation |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2024-12-01
- Completion
- 2025-05-01
- First posted
- 2022-07-28
- Last updated
- 2023-12-06
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05478902. Inclusion in this directory is not an endorsement.