Clinical trial NCT05106842: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Passive forward flexion
timeFrame: 1.5 months
Secondary outcomes:
measure: Pain (Visual Analogue Scale)
timeFrame: 1.5 months
measure: Constant Score
timeFrame: 1.5 months
measure: Single Assessment Numeric Evaluation (SANE) score
timeFrame: 1.5 months
Other outcomes:
Locations:
city: Meyrin
country: Switzerland
facility: La Tour Hospital
state: Geneva
Study officials:
affiliation: La Tour Hospital
name: Alexandre Lädermann, MD
role: PRINCIPAL_INVESTIGATOR
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