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Completed

NCT Number: NCT05106842

Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrotherapy

Other

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

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

La Tour Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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