Rotator Cuff TearsNCT05106842

Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

A study testing Hydrotherapy and Land-based Therapy in people with Rotator Cuff Tears, run by La Tour Hospital at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Rotator Cuff Tears
What is being tested?: Hydrotherapy and Land-based Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteSwitzerland
Study dates: 13 Mar 2017to 31 Mar 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

La Tour Hospital
Meyrin, Canton of Geneva, 1217

Other trials in Switzerland

About this study

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

Read the 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).

Conditions: Rotator Cuff Tears
Being tested: Hydrotherapy, Land-based Therapy
Medical subject headings: Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydrotherapyOther
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 TherapyOther
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.

Study groups in NCT05106842
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Land-based Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1.5 months

Secondary outcomes (3)

Pain (Visual Analogue Scale)
Minimum score is 0 while maximum score is 10. The higher the score, the worse is the outcome.
Measured: 1.5 months
Constant Score
Minimum score is 0 while maximum score is 100. The higher the score, the better is the outcome.
Measured: 1.5 months
Single Assessment Numeric Evaluation (SANE) score
Minimum score is 0 while the maximum score is 100. The higher the score, the better the outcome.
Measured: 1.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201731 Mar 2018

First posted4 Nov 2021
Study start13 Mar 2017
Primary completion31 Mar 2018
Study completion31 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05106842
Sponsor's protocol ID: LaTourH
Status last verified: Oct 2021
First submitted: 18 Aug 2021
Last updated: 4 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 18548557
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.
PubMed 26206216
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.
PubMed 31764223
Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PubMed 3791738
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.
PubMed 23705108
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.
PubMed 19194025
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.
PubMed 19735951
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.
PubMed 18061114
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.
PubMed 23850308
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.
PubMed 32326198
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.
PubMed 28111006
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.
PubMed 16282408
Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
PubMed 2323151
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.
PubMed 19406293
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.
PubMed 8291638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears

All Rotator Cuff Tears trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair: a Randomized Prospective Study
ClinicalTrials.gov ID: NCT05106842
Acronym / sponsor ID: LaTourH
Conditions: Rotator Cuff Tears
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: La Tour HospitalUniversity, hospital or other
Study start: 13 Mar 2017 (actual)
Primary completion: 31 Mar 2018 (actual)
Study completion: 31 Mar 2018 (actual)
First posted: 4 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Introduction:

Methods:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.

Arm	Type	Receives
Hydrotherapy after Rotator Cuff Repair	Active comparator	Other: HydrotherapyThe participants will start with passive mobilization right after surgery for 4 weeks. Intervention in hydrotherapy will follow after that.
Classical Land Based Rehabilitation after Rotator Cuff Repair	Active comparator	Other: Land-based TherapyThe participants will start with passive mobilization right after surgery for 4 weeks. Intervention in classic dry land based rehabilitation will follow after that.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HydrotherapyAquatic 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.	Other	Hydrotherapy after Rotator Cuff Repair
Land-based TherapyLand-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.	Other	Classical Land Based Rehabilitation after Rotator Cuff Repair

Primary outcome

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.

3 secondary outcomes

Pain (Visual Analogue Scale)
Time frame: 1.5 months
Constant Score
Time frame: 1.5 months
Single Assessment Numeric Evaluation (SANE) score
Time frame: 1.5 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
Background: PubMed 18548557Brady 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.
Background: PubMed 26206216Burmaster 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.
Background: PubMed 31764223Chae 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.
Background: PubMed 3791738Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
Background: PubMed 23705108Cuesta-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.
Background: PubMed 19194025Ghodadra 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.
Background: PubMed 19735951Giaquinto 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.
Background: PubMed 18061114Gilbart 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.
Background: PubMed 23850308Kukkonen 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.
Background: PubMed 32326198Longo 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.
Background: PubMed 28111006Mazzocca 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.
Background: PubMed 16282408Mitchell 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.
Individual participant dataSharing planned: No

Related trials for Rotator Cuff Tears

Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexandre Lädermann, MD principal investigator

La Tour Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hydrotherapy and Land-based Therapy in people with Rotator Cuff Tears, run by La Tour Hospital at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Passive forward flexion (time frame: 1.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05106842, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.