Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair
NCT ID: NCT05106842
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2017-03-13
2018-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* SLAP lesion;
* Second rotator cuff surgery;
* Frozen shoulder (i.e. Forward flexion reduced of 25% or more);
* Inability to follow the study protocol
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
La Tour Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Alexandre Lädermann
Sponsor-Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandre Lädermann, MD
Role: PRINCIPAL_INVESTIGATOR
La Tour Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
La Tour Hospital
Meyrin, Canton of Geneva, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
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.
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.
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.
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.
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.
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.
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.
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.
Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LaTourH
Identifier Type: -
Identifier Source: org_study_id