- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613998
Physiotherapy Treatment of Shoulder Rotator Cuff Tendinopathies. Global Postural Reeducation or Aerobic Exercise?
Global Postural Reeducation vs. Non-specific Therapeutic Exercise in the Treatment of Rotator Cuff Tendinopathies of the Shoulder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants who meet the inclusion criteria will be randomly distributed between group 1 "Global Postural Reeducation (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-minutes 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spain, 28223
- Francisco de Vitoria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1. Global Postural Reeducation (GPR) intervention
Patients who will receive the Global Postural Reeducation (GPR) treatment protocol
|
6-week treatment using the Global Postural Reeducation (GPR) method. 1 weekly session (45 min) with "frog on the ground" and "sitting" postures + daily home self-postures (10 min)
|
|
Experimental: Group 2. Non-specific Aerobic exercice intervention
Patients who will receive the non-specific aerobic exercise treatment protocol
|
6-week nonspecific aerobic exercise treatment.
Participants will take a daily walk (20 min)
|
|
No Intervention: Group 3. No physiotherapy intervention
Patients who will not receive physiotherapy treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in pain and disability after the treatment program
Time Frame: Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
Shoulder Pain and Disability Index (SPADI).
Minimum value=0.
Maximun value=100
|
Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
|
Changes in pain and disability after the treatment program
Time Frame: Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
The Disabilities of the Arm, Shoulder and Hand (Quick-DASH).
Minimum value=0.
Maximun value=100
|
Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in pressure pain sensitivity
Time Frame: Pre, Post inmediate, and follow-up at 3 and 6 months
|
Pressure Pain Thresholds (PPH)
|
Pre, Post inmediate, and follow-up at 3 and 6 months
|
|
Changes in Range of Motion
Time Frame: Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
Goniometer
|
Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
|
Changes in pain after the treatment program
Time Frame: Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
Numerical Pain Rating Scale (NPRS).
Minimum value=0 (no pain).
Maximun value=10 (the worst pain imaginable)
|
Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
|
Changes in Quality of Life
Time Frame: Baseline, one week after the last session, 3 months and 6 months after the last session
|
Short-Form 12 Health Status Questionnaire. The response options form Likert-type scales that evaluate intensity or frequency. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. |
Baseline, one week after the last session, 3 months and 6 months after the last session
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in stifness (cervical plexus, radial nerve, supraespinatus and infraespinatus muscles)
Time Frame: Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
Ultrasound Shear-Wave elastography
|
Baseline, one week after the last sessio, 3 months and 6 months after the last session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier Alvarez-González, Francisco de Vitoria University, Madrid, Spain
- Study Director: Arturo Morales-Muñiz, PhD, Autonomous University of Madrid, Madrid, Spain
- Study Chair: Alfredo Bravo-Sánchez, PhD, Francisco de Vitoria University, Madrid, Spain
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- van der Heijden GJ, van der Windt DA, de Winter AF. Physiotherapy for patients with soft tissue shoulder disorders: a systematic review of randomised clinical trials. BMJ. 1997 Jul 5;315(7099):25-30. doi: 10.1136/bmj.315.7099.25.
- Marinko LN, Chacko JM, Dalton D, Chacko CC. The effectiveness of therapeutic exercise for painful shoulder conditions: a meta-analysis. J Shoulder Elbow Surg. 2011 Dec;20(8):1351-9. doi: 10.1016/j.jse.2011.05.013. Epub 2011 Sep 1.
- Naugle KM, Fillingim RB, Riley JL 3rd. A meta-analytic review of the hypoalgesic effects of exercise. J Pain. 2012 Dec;13(12):1139-50. doi: 10.1016/j.jpain.2012.09.006. Epub 2012 Nov 8.
- 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.
- Kosek E, Ekholm J. Modulation of pressure pain thresholds during and following isometric contraction. Pain. 1995 Jun;61(3):481-486. doi: 10.1016/0304-3959(94)00217-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RPGEI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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