NCT05613998

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

October 30, 2022

Last Update Submit

January 20, 2026

Conditions

Keywords

TendinopathyRotator CuffGlobal Postural ReeducationAerobic ExerciceShoulder PainQuality of life

Outcome Measures

Primary Outcomes (2)

  • Changes in pain and disability after the treatment program

    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

    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 Outcomes (4)

  • Changes in pain after the treatment program

    Baseline, one week after the last sessio, 3 months and 6 months after the last session

  • Changes in pressure pain sensitivity

    Pre, Post inmediate, and follow-up at 3 and 6 months

  • Changes in Quality of Life

    Baseline, one week after the last session, 3 months and 6 months after the last session

  • Changes in Range of Motion

    Baseline, one week after the last sessio, 3 months and 6 months after the last session

Other Outcomes (1)

  • Changes in stifness (cervical plexus, radial nerve, supraespinatus and infraespinatus muscles)

    Baseline, one week after the last sessio, 3 months and 6 months after the last session

Study Arms (3)

Group 1. Global Postural Reeducation (GPR) intervention

EXPERIMENTAL

Patients who will receive the Global Postural Reeducation (GPR) treatment protocol

Other: GPR Group

Group 2. Non-specific Aerobic exercice intervention

EXPERIMENTAL

Patients who will receive the non-specific aerobic exercise treatment protocol

Other: Aerobic Exercice Group

Group 3. No physiotherapy intervention

NO INTERVENTION

Patients who will not receive physiotherapy treatment

Interventions

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)

Group 1. Global Postural Reeducation (GPR) intervention

6-week nonspecific aerobic exercise treatment. Participants will take a daily walk (20 min)

Group 2. Non-specific Aerobic exercice intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco de Vitoria University

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Related Publications (8)

  • 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.

    PMID: 9233322BACKGROUND
  • 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.

    PMID: 21889366BACKGROUND
  • 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.

    PMID: 22507359BACKGROUND
  • 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.

    PMID: 7478692BACKGROUND
  • 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.

    PMID: 23141188BACKGROUND
  • 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.

    PMID: 25092553BACKGROUND
  • 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.

    PMID: 27884499BACKGROUND
  • 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.

    PMID: 29163981BACKGROUND

MeSH Terms

Conditions

Rotator Cuff InjuriesTendinopathyShoulder Pain

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesMuscular DiseasesMusculoskeletal DiseasesArthralgiaJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Javier Alvarez-González

    Francisco de Vitoria University, Madrid, Spain

    PRINCIPAL INVESTIGATOR
  • Arturo Morales-Muñiz, PhD

    Autonomous University of Madrid, Madrid, Spain

    STUDY DIRECTOR
  • Alfredo Bravo-Sánchez, PhD

    Francisco de Vitoria University, Madrid, Spain

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 14, 2022

Study Start

October 30, 2022

Primary Completion

December 31, 2024

Study Completion

January 10, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
6 months after publication
Access Criteria
Mail to the IP describing the interest and the purpose for accessing the data

Locations