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Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hydrotherapy
Land-based Therapy
Sponsored by
La Tour Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • La Tour Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hydrotherapy after Rotator Cuff Repair

Classical Land Based Rehabilitation after Rotator Cuff Repair

Arm Description

The participants will start with passive mobilization right after surgery for 4 weeks. Intervention in hydrotherapy will follow after that.

The participants will start with passive mobilization right after surgery for 4 weeks. Intervention in classic dry land based rehabilitation will follow after that.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain (Visual Analogue Scale)
Minimum score is 0 while maximum score is 10. The higher the score, the worse is the outcome.
Constant Score
Minimum score is 0 while maximum score is 100. The higher the score, the better is the outcome.
Single Assessment Numeric Evaluation (SANE) score
Minimum score is 0 while the maximum score is 100. The higher the score, the better the outcome.

Full Information

First Posted
August 18, 2021
Last Updated
November 3, 2021
Sponsor
La Tour Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05106842
Brief Title
Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair
Official Title
Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair: a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
La Tour Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.
Masking
Outcomes Assessor
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.
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrotherapy after Rotator Cuff Repair
Arm Type
Active Comparator
Arm Description
The participants will start with passive mobilization right after surgery for 4 weeks. Intervention in hydrotherapy will follow after that.
Arm Title
Classical Land Based Rehabilitation after Rotator Cuff Repair
Arm Type
Active Comparator
Arm Description
The participants will start with passive mobilization right after surgery for 4 weeks. Intervention in classic dry land based rehabilitation will follow after that.
Intervention Type
Other
Intervention Name(s)
Hydrotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Land-based Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Passive forward flexion
Description
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.
Time Frame
1.5 months
Secondary Outcome Measure Information:
Title
Pain (Visual Analogue Scale)
Description
Minimum score is 0 while maximum score is 10. The higher the score, the worse is the outcome.
Time Frame
1.5 months
Title
Constant Score
Description
Minimum score is 0 while maximum score is 100. The higher the score, the better is the outcome.
Time Frame
1.5 months
Title
Single Assessment Numeric Evaluation (SANE) score
Description
Minimum score is 0 while the maximum score is 100. The higher the score, the better the outcome.
Time Frame
1.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Lädermann, MD
Organizational Affiliation
La Tour Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Tour Hospital
City
Meyrin
State/Province
Geneva
ZIP/Postal Code
1217
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
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Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

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