Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

NCT05106842 | Completed

• 1 other identifier: LaTourH
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• 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.

  1.5 months

Secondary Outcomes (3)

• Pain (Visual Analogue Scale)

  1.5 months

• Constant Score

  1.5 months

• Single Assessment Numeric Evaluation (SANE) score

  1.5 months

Study Arms (2)

Hydrotherapy after Rotator Cuff Repair

ACTIVE COMPARATOR

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

Other: Hydrotherapy

Classical Land Based Rehabilitation after Rotator Cuff Repair

ACTIVE COMPARATOR

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

Other: Land-based Therapy

Interventions

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.

Hydrotherapy after Rotator Cuff Repair

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.

Classical Land Based Rehabilitation after Rotator Cuff Repair

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• La Tour Hospital: lead

Study Sites (1)

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

Location

Related Publications (17)

• 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.

  PMID: 18548557 BACKGROUND

• 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.

  PMID: 26206216 BACKGROUND

• 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.

  PMID: 31764223 BACKGROUND

• Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

  PMID: 3791738 BACKGROUND

• 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.

  PMID: 23705108 BACKGROUND

• 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.

  PMID: 19194025 BACKGROUND

• 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.

  PMID: 19735951 BACKGROUND

• 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.

  PMID: 18061114 BACKGROUND

• 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.

  PMID: 23850308 BACKGROUND

• 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.

  PMID: 32326198 BACKGROUND

• 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.

  PMID: 28111006 BACKGROUND

• 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.

  PMID: 16282408 BACKGROUND

• Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.

  PMID: 2323151 BACKGROUND

• 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.

  PMID: 19406293 BACKGROUND

• 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.

  PMID: 8291638 BACKGROUND

• 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.

  PMID: 26510584 BACKGROUND

• 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.

  PMID: 15590865 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Alexandre Lädermann, MD

  La Tour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: November 4, 2021
• Study Start: March 13, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)