Subacromial Impingement of the Shoulder Clinical Trial
— SCAPULEOOfficial title:
Glenohumeral Re-centering During Closed Kinetic Chain for Shoulder Physiotherapy. A Prospective and Randomized Study.
| Verified date | May 2021 |
| Source | CHU de Reims |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The rotator cuff tendinopathy is very common and associated with degenerative or traumatic changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps. Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff which means a loss of mobility or strength. The origin of this pathology remains controversial and many causes have been evoked (subacromial mechanical impingement, degenerative changes, muscle imbalance…). The clinical impairment is not always the same and varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder. The first treatment of the rotator cuff pathology is always non surgical and consists in relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and physiotherapy. The aim of this management is to relieve pain and to restore the mobility and a good function of the shoulder. There is no consensus about the physiotherapy protocol for the treatment of the rotator cuff tendinopathy. In France, the most used physiotherapy protocol uses the strengthening of the muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this approach is to augment the subacromial space in order to decrease the inflammation of the rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC) uses a new method of glenohumeral centering in closed kinetic chain has been described ("3C Concept" for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order to simplify and to improve its reliability, a special device called Scapuleo® has been developed. The aim of this device is to help the physiotherapist to realize simultaneously a subacromial decompression, a specific strengthening of the rotator cuff muscles and an optimal activation of the lower trapezius and the anterior serratus. Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol for the medical treatment of the rotator cuff tendinopathy without full-thickness tear. We proposed a prospective and randomized study. All the patients treated in our department for simple tendinopathy of the rotator cuff or partial thickness tear were included in this study after signed consent. The physiotherapy protocol consists in 20 sessions of either "Conventional program" (Control group) or "Dynamic Humeral Centering" (Study group). The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study hypothesis. The assessor of all outcomes was blinded to the interventions.
| Status | Terminated |
| Enrollment | 24 |
| Est. completion date | February 26, 2021 |
| Est. primary completion date | May 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Painful shoulder causes by tendinopathy of the rotator cuff (without full-thickness tear) - Diagnosis based on a MRI (dating less than 6 months) Exclusion Criteria: - Tendinopathy of the rotator cuff with full-thickness tear - Stiffness of the shoulder (loss of more than 20° in passive external rotation or passive forward elevation) - Previous shoulder surgery (less than 12 months) - Previous subacromial injection (less than 6 months) - Context of worker's compensation claims |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu de Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Functional status of the shoulder | Functional status of the shoulder evaluated using the Constant & Murley Score | 6 months | |
| Secondary | Functional status of the shoulder | Functional status of the shoulder evaluated using the Constant & Murley Score | 3 months | |
| Secondary | Disabilities of the Arm, Shoulder and Hand score | Disabilities of the Arm, Shoulder and Hand score evaluated using the Quick-DASH (short form), self reported questionnaire (12 questions) | 3 months | |
| Secondary | Disabilities of the Arm, Shoulder and Hand score | Disabilities of the Arm, Shoulder and Hand score evaluated using the Quick-DASH (short form), self reported questionnaire (12 questions) | 6 months | |
| Secondary | Functional status of the shoulder | Functional status of the shoulder evaluated using Oxford Shoulder Score, self reported questionnaire (12 questions) | 3 months | |
| Secondary | Functional status of the shoulder | Functional status of the shoulder evaluated using Oxford Shoulder Score, self reported questionnaire (12 questions) | 6 months | |
| Secondary | pain | Shoulder pain evaluated using a visual analogic pain scale | 3 months | |
| Secondary | pain | Shoulder pain evaluated using a visual analogic pain scale | 6 months |