Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

Not Applicable

Completed

• Conditions: Rotator Cuff Tears

• Registration Number: NCT05106842
• Lead Sponsor: La Tour Hospital

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).

Study Timeline

• Study Start: 2017-03-13
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Study First Submitted: 2021-08-18
• Status Verified: 2021-10
• Study First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

La Tour Hospital; 🇨🇭 Meyrin, Geneva, Switzerland