Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

Study Overview
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Brief Summary
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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
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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).

Official Title
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Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair: a Randomized Prospective Study

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Other: Hydrotherapy
* Other: Land-based Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrotherapy after Rotator Cuff Repair<br>The participants will start with passive mobilization right after surgery for 4 weeks. Intervention in hydrotherapy will follow after that. | Other: Hydrotherapy<br>* 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.<br>|
| Active Comparator: Classical Land Based Rehabilitation after Rotator Cuff Repair<br>The participants will start with passive mobilization right after surgery for 4 weeks. Intervention in classic dry land based rehabilitation will follow after that. | Other: Land-based Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passive forward flexion | 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. | 1.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Visual Analogue Scale) | Minimum score is 0 while maximum score is 10. The higher the score, the worse is the outcome. | 1.5 months | 
| Constant Score | Minimum score is 0 while maximum score is 100. The higher the score, the better is the outcome. | 1.5 months | 
| Single Assessment Numeric Evaluation (SANE) score | Minimum score is 0 while the maximum score is 100. The higher the score, the better the outcome. | 1.5 months |