Rotator Cuff Tears
Conditions
Brief summary
Postoperative rehabilitation following rotator cuff repair is important to promote tendon healing, restore strength, and recover normal function. The aim of this study is to assess whether aquatic rehabilitation is more efficient than classical rehabilitation (land-based session) in term of range of motion, function, and pain than classical rehabilitation (land-based session) after an arthroscopic repair of the rotator cuff.
Detailed description
Introduction: Postoperative rehabilitation following rotator cuff repair is important to promote tendon healing, restore strength, and recover normal function. Aquatic rehabilitation in hot water allows body relaxation and well-being that promote patient conditioning for efficient rehabilitation and is appreciated by patients. The aim of this study is to assess whether aquatic rehabilitation is more efficient than classical rehabilitation (land-based session) in term of range of motion, function, and pain after an arthroscopic repair of the rotator cuff. Methods: This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based (standard) rehabilitation. This superiority trial that included 84 patients that have benefited from an arthroscopic superior cuff repair. Patients were evaluated clinically at 6 weeks, 3, 6 and 24 months and using ultrasound at 6 months. Multivariable linear regressions were performed to determine if 2-year postoperative scores were associated with gender, body mass index (BMI), age at index operation, rehabilitation group (Hydrotherapy vs Standard), and baseline passive range of motion (PROM) Active range of motion (AROM).
Interventions
Aquatic therapy was performed in a swimming pool (depth 125-140 cm, temperature 28-31°C) supervised by a physiotherapist. Patients were asked to kneel or sit to submerge both shoulders to perform exercises consisting of progressive passive and active motion of the shoulder for 4-6 weeks, then strengthening exercises in a swimming pool for 2-4 months.
Land-based therapy was performed at a rehabilitation center supervised by a physiotherapist. Patients performed progressive passive and active-assisted motion of the shoulder for 4-6 weeks, then strengthening exercises for 2-4 months.
Sponsors
Study design
Masking description
Medical history, demographics, and clinical scores will be collected by the selected and blinded investigator (on corresponding case reporting forms). Patients will be informed of the blinding procedure. They should not unblind investigator during the whole follow-up.
Intervention model description
This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.
Eligibility
Inclusion criteria
* 18 years old or more * Arthroscopic cuff repair of supraspinatus tendon (with potentially concomitant of infraspinatus tendon repair, tenodesis or tenotomy of brachial biceps tendon, acromioplasty, and distal clavicle removal).
Exclusion criteria
* Lesion of subscapularis tendon; * SLAP lesion; * Second rotator cuff surgery; * Frozen shoulder (i.e. Forward flexion reduced of 25% or more); * Inability to follow the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Passive forward flexion | 1.5 months | As primary outcome, we will evaluate if passive antepulsion is superior with balneotherapy than classical rehabilitation (land-based session). We consider the effective intervention with a 105 ° forward flexion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain (Visual Analogue Scale) | 1.5 months | Minimum score is 0 while maximum score is 10. The higher the score, the worse is the outcome. |
| Constant Score | 1.5 months | Minimum score is 0 while maximum score is 100. The higher the score, the better is the outcome. |
| Single Assessment Numeric Evaluation (SANE) score | 1.5 months | Minimum score is 0 while the maximum score is 100. The higher the score, the better the outcome. |
Countries
Switzerland