Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

November 3, 2021 updated by: Dr. Alexandre Lädermann, La Tour Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Geneva
      • Meyrin, Geneva, Switzerland, 1217
        • La Tour Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hydrotherapy after Rotator Cuff Repair
The participants will start with passive mobilization right after surgery for 4 weeks. Intervention in hydrotherapy will follow after that.
Other: Hydrotherapy
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.
ACTIVE_COMPARATOR: Classical Land Based Rehabilitation after Rotator Cuff Repair
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passive forward flexion
Time Frame: 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.
1.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (Visual Analogue Scale)
Time Frame: 1.5 months
Minimum score is 0 while maximum score is 10. The higher the score, the worse is the outcome.
1.5 months
Constant Score
Time Frame: 1.5 months
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
Time Frame: 1.5 months
Minimum score is 0 while the maximum score is 100. The higher the score, the better the outcome.
1.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

La Tour Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2017

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

March 31, 2018

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (ACTUAL)

November 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaTourH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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