Back to resultsPhysiotherapy Treatment of Shoulder Rotator Cuff Tendinopathies. Global Postural Reeducation or Aerobic Exercise?
Primary Purpose
Rotator Cuff Tendinosis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GPR Group
Aerobic Exercice Group
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tendinosis focused on measuring Tendinopathy, Rotator Cuff, Global Postural Reeducation, Aerobic Exercice, Shoulder Pain, Quality of life
Eligibility Criteria
Inclusion Criteria: Shoulder pain with duration of at least 3 months Positive painful arc test during abduction At least one positive of the following tests: Hawkins-Kennedy test, Neer's sig, empty can test, drop arm or lift-off test Exclusion Criteria: Cervical radiculopathy Moderate or severe degenerative arthropathy Complete rotator cuff tear History of shoulder or neck surgery History of shoulder fractures or dislocation Frozen shoulder or adhesive capsulitis Previous interventions with steroid injections or physiotherapy 2 months before the start of the program
Sites / Locations
- Francisco de Vitoria UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
GR1. GPR intervention
GR2. Non-specific Aerobic exercice intervention
GR3. No physiotherapy intervention
Arm Description
Patients who will receive the GRP treatment protocol
Patients who will receive the non-specific aerobic exercise treatment protocol
Patients who will not receive physiotherapy treatment
Outcomes
Primary Outcome Measures
Changes in pain and disability after the treatment program
Shoulder Pain and Disability Index (SPADI)
Changes in pain and disability after the treatment program
The Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Secondary Outcome Measures
Changes in pain after the treatment program
Numerical Pain Rating Scale (NPRS)
Changes in pressure pain sensitivity
Pressure Pain Thresholds (PPH)
Changes in Quality of Life
SF12 Health Status Questionnaire
Changes in Range of Motion
Goniometer
Full Information
NCT ID
NCT05613998
First Posted
October 30, 2022
Last Updated
November 6, 2022
Sponsor
Universidad Francisco de Vitoria
1. Study Identification
Unique Protocol Identification Number
NCT05613998
Brief Title
Physiotherapy Treatment of Shoulder Rotator Cuff Tendinopathies. Global Postural Reeducation or Aerobic Exercise?
Official Title
Global Postural Reeducation vs. Non-specific Therapeutic Exercise in the Treatment of Rotator Cuff Tendinopathies of the Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Francisco de Vitoria
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
The goal of this clinical trial is to compare in participant population (patients with rotator cuff tendinopathy of the shoulder) the effect of a Global Postural Reeducation (GPR) program vs. a nonspecific therapeutic (aerobic) exercise program
Detailed Description
Participants who meet the inclusion criteria will be randomly distributed between group 1 "GPR", group 2 "exercise", or group 3 "no physical therapy intervention".
Group 1 participants will receive a physical therapy treatment using the GPR method for 6 weeks consisting of 1 weekly session lasting 40 min performing "frog on the ground" and "sitting" poses. Patients in this group will also perform self-postures at home daily for 10 minutes.
Group 2 participants perform training for 6 weeks using non-specific aerobic exercise consisting of a daily 20-minute walk at a speed of 4-5 km/h.
Group 3 participants will not receive any physical therapy treatment and will serve as a control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinosis
Keywords
Tendinopathy, Rotator Cuff, Global Postural Reeducation, Aerobic Exercice, Shoulder Pain, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GR1. GPR intervention
Arm Type
Experimental
Arm Description
Patients who will receive the GRP treatment protocol
Arm Title
GR2. Non-specific Aerobic exercice intervention
Arm Type
Experimental
Arm Description
Patients who will receive the non-specific aerobic exercise treatment protocol
Arm Title
GR3. No physiotherapy intervention
Arm Type
No Intervention
Arm Description
Patients who will not receive physiotherapy treatment
Intervention Type
Other
Intervention Name(s)
GPR Group
Intervention Description
6-week treatment using the GPR method. 1 weekly session (45 min) with "frog on the ground" and "sitting" postures + daily home self-postures (10 min)
Intervention Type
Other
Intervention Name(s)
Aerobic Exercice Group
Intervention Description
6-week nonspecific aerobic exercise treatment. Participants will take a daily walk (20 min)
Primary Outcome Measure Information:
Title
Changes in pain and disability after the treatment program
Description
Shoulder Pain and Disability Index (SPADI)
Time Frame
Baseline, one week after the last sessio, 3 months and 6 months after the last session
Title
Changes in pain and disability after the treatment program
Description
The Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Time Frame
Baseline, one week after the last sessio, 3 months and 6 months after the last session
Secondary Outcome Measure Information:
Title
Changes in pain after the treatment program
Description
Numerical Pain Rating Scale (NPRS)
Time Frame
Baseline, one week after the last sessio, 3 months and 6 months after the last session
Title
Changes in pressure pain sensitivity
Description
Pressure Pain Thresholds (PPH)
Time Frame
Pre, Post inmediate, and follow-up at 3 and 6 months
Title
Changes in Quality of Life
Description
SF12 Health Status Questionnaire
Time Frame
Baseline, one week after the last sessio, 3 months and 6 months after the last session
Title
Changes in Range of Motion
Description
Goniometer
Time Frame
Baseline, one week after the last sessio, 3 months and 6 months after the last session
Other Pre-specified Outcome Measures:
Title
Changes in stifness (cervical plexus, radial nerve, supraespinatus and infraespinatus muscles)
Description
Ultrasound Shear-Wave elastography
Time Frame
Baseline, one week after the last sessio, 3 months and 6 months after the last session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Shoulder pain with duration of at least 3 months
Positive painful arc test during abduction
At least one positive of the following tests: Hawkins-Kennedy test, Neer's sig, empty can test, drop arm or lift-off test
Exclusion Criteria:
Cervical radiculopathy
Moderate or severe degenerative arthropathy
Complete rotator cuff tear
History of shoulder or neck surgery
History of shoulder fractures or dislocation
Frozen shoulder or adhesive capsulitis
Previous interventions with steroid injections or physiotherapy 2 months before the start of the program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Alvarez-González
Phone
+34629483292
Email
j.alvarezglez.prof@ufv.es
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Alvarez-González
Phone
(+34)629483292
Email
javierfisio@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Alvarez-González
Organizational Affiliation
Francisco de Vitoria University, Madrid, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arturo Morales-Muñiz, PhD
Organizational Affiliation
Autonomous University of Madrid, Madrid, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pablo Terrón-Manrique, PhD
Organizational Affiliation
Francisco de Vitoria University, Madrid, Spain
Official's Role
Study Chair
Facility Information:
Facility Name
Francisco de Vitoria University
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvarez-González
Email
javierfisio@yahoo.es
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Mail to the IP describing the interest and the purpose for accessing the data
Citations:
PubMed Identifier
9233322
Citation
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Results Reference
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PubMed Identifier
21889366
Citation
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Results Reference
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PubMed Identifier
22507359
Citation
Littlewood C, Ashton J, Chance-Larsen K, May S, Sturrock B. Exercise for rotator cuff tendinopathy: a systematic review. Physiotherapy. 2012 Jun;98(2):101-9. doi: 10.1016/j.physio.2011.08.002. Epub 2011 Oct 5.
Results Reference
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PubMed Identifier
7478692
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
25092553
Citation
Amorim CS, Gracitelli ME, Marques AP, Alves VL. Effectiveness of global postural reeducation compared to segmental exercises on function, pain, and quality of life of patients with scapular dyskinesis associated with neck pain: a preliminary clinical trial. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):441-7. doi: 10.1016/j.jmpt.2013.08.011. Epub 2014 Aug 3.
Results Reference
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PubMed Identifier
27884499
Citation
Heron SR, Woby SR, Thompson DP. Comparison of three types of exercise in the treatment of rotator cuff tendinopathy/shoulder impingement syndrome: A randomized controlled trial. Physiotherapy. 2017 Jun;103(2):167-173. doi: 10.1016/j.physio.2016.09.001. Epub 2016 Sep 21.
Results Reference
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PubMed Identifier
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Citation
Kinsella R, Cowan SM, Watson L, Pizzari T. A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2017 Nov 14;3:45. doi: 10.1186/s40814-017-0190-3. eCollection 2017.
Results Reference
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Physiotherapy Treatment of Shoulder Rotator Cuff Tendinopathies. Global Postural Reeducation or Aerobic Exercise?
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