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
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
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
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
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
Citations:
PubMed Identifier
18548557
Citation
Brady B, Redfern J, MacDougal G, Williams J. The addition of aquatic therapy to rehabilitation following surgical rotator cuff repair: a feasibility study. Physiother Res Int. 2008 Sep;13(3):153-61. doi: 10.1002/pri.403.
Results Reference
background
PubMed Identifier
26206216
Citation
Burmaster C, Eckenrode BJ, Stiebel M. Early Incorporation of an Evidence-Based Aquatic-Assisted Approach to Arthroscopic Rotator Cuff Repair Rehabilitation: Prospective Case Study. Phys Ther. 2016 Jan;96(1):53-61. doi: 10.2522/ptj.20140178. Epub 2015 Jul 23.
Results Reference
background
PubMed Identifier
31764223
Citation
Chae CS, Jun JH, Im S, Jang Y, Park GY. Effectiveness of Hydrotherapy on Balance and Paretic Knee Strength in Patients With Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2020 May;99(5):409-419. doi: 10.1097/PHM.0000000000001357.
Results Reference
background
PubMed Identifier
3791738
Citation
Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
Results Reference
background
PubMed Identifier
23705108
Citation
Cuesta-Vargas AI, Cano-Herrera C, Formosa D, Burkett B. Electromyographic responses during time get up and go test in water (wTUG). Springerplus. 2013 May 10;2(1):217. doi: 10.1186/2193-1801-2-217. Print 2013 Dec.
Results Reference
background
PubMed Identifier
19194025
Citation
Ghodadra NS, Provencher MT, Verma NN, Wilk KE, Romeo AA. Open, mini-open, and all-arthroscopic rotator cuff repair surgery: indications and implications for rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):81-9. doi: 10.2519/jospt.2009.2918.
Results Reference
background
PubMed Identifier
19735951
Citation
Giaquinto S, Ciotola E, Dall'Armi V, Margutti F. Hydrotherapy after total knee arthroplasty. A follow-up study. Arch Gerontol Geriatr. 2010 Jul-Aug;51(1):59-63. doi: 10.1016/j.archger.2009.07.007. Epub 2009 Sep 6.
Results Reference
background
PubMed Identifier
18061114
Citation
Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.
Results Reference
background
PubMed Identifier
23850308
Citation
Kukkonen J, Kauko T, Vahlberg T, Joukainen A, Aarimaa V. Investigating minimal clinically important difference for Constant score in patients undergoing rotator cuff surgery. J Shoulder Elbow Surg. 2013 Dec;22(12):1650-5. doi: 10.1016/j.jse.2013.05.002. Epub 2013 Jul 12.
Results Reference
background
PubMed Identifier
32326198
Citation
Longo UG, Berton A, Risi Ambrogioni L, Lo Presti D, Carnevale A, Candela V, Stelitano G, Schena E, Nazarian A, Denaro V. Cost-Effectiveness of Supervised versus Unsupervised Rehabilitation for Rotator-Cuff Repair: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2020 Apr 21;17(8):2852. doi: 10.3390/ijerph17082852.
Results Reference
background
PubMed Identifier
28111006
Citation
Mazzocca AD, Arciero RA, Shea KP, Apostolakos JM, Solovyova O, Gomlinski G, Wojcik KE, Tafuto V, Stock H, Cote MP. The Effect of Early Range of Motion on Quality of Life, Clinical Outcome, and Repair Integrity After Arthroscopic Rotator Cuff Repair. Arthroscopy. 2017 Jun;33(6):1138-1148. doi: 10.1016/j.arthro.2016.10.017. Epub 2017 Jan 19.
Results Reference
background
PubMed Identifier
16282408
Citation
Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
Results Reference
background
PubMed Identifier
2323151
Citation
Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
Results Reference
background
PubMed Identifier
19406293
Citation
Rahmann AE, Brauer SG, Nitz JC. A specific inpatient aquatic physiotherapy program improves strength after total hip or knee replacement surgery: a randomized controlled trial. Arch Phys Med Rehabil. 2009 May;90(5):745-55. doi: 10.1016/j.apmr.2008.12.011.
Results Reference
background
PubMed Identifier
8291638
Citation
Speer KP, Cavanaugh JT, Warren RF, Day L, Wickiewicz TL. A role for hydrotherapy in shoulder rehabilitation. Am J Sports Med. 1993 Nov-Dec;21(6):850-3. doi: 10.1177/036354659302100616. No abstract available.
Results Reference
background
PubMed Identifier
26510584
Citation
Thomson S, Jukes C, Lewis J. Rehabilitation following surgical repair of the rotator cuff: a systematic review. Physiotherapy. 2016 Mar;102(1):20-8. doi: 10.1016/j.physio.2015.08.003. Epub 2015 Sep 8.
Results Reference
background
PubMed Identifier
15590865
Citation
Williams GR Jr, Rockwood CA Jr, Bigliani LU, Iannotti JP, Stanwood W. Rotator cuff tears: why do we repair them? J Bone Joint Surg Am. 2004 Dec;86(12):2764-76. No abstract available.
Results Reference
background
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Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair
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