Physiotherapy Treatment of Shoulder Rotator Cuff Tendinopathies. Global Postural Reeducation or Aerobic Exercise?

Sponsor

Universidad Francisco de Vitoria (Other)

Overall Status

Recruiting

CT.gov ID

NCT05613998

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tendinosis	Other: GPR Group Other: Aerobic Exercice Group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Global Postural Reeducation vs. Non-specific Therapeutic Exercise in the Treatment of Rotator Cuff Tendinopathies of the Shoulder

Actual Study Start Date :

Oct 30, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GR1. GPR intervention Patients who will receive the GRP treatment protocol	Other: GPR Group 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)
Experimental: GR2. Non-specific Aerobic exercice intervention Patients who will receive the non-specific aerobic exercise treatment protocol	Other: Aerobic Exercice Group 6-week nonspecific aerobic exercise treatment. Participants will take a daily walk (20 min)
No Intervention: GR3. No physiotherapy intervention Patients who will not receive physiotherapy treatment

Arm

Intervention/Treatment

Experimental: GR1. GPR intervention

Patients who will receive the GRP treatment protocol

Other: GPR Group

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)

Experimental: GR2. Non-specific Aerobic exercice intervention

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

Other: Aerobic Exercice Group

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

No Intervention: GR3. No physiotherapy intervention

Patients who will not receive physiotherapy treatment

Outcome Measures

Primary Outcome Measures

Changes in pain and disability after the treatment program [Baseline, one week after the last sessio, 3 months and 6 months after the last session]
Shoulder Pain and Disability Index (SPADI)
Changes in pain and disability after the treatment program [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)

Secondary Outcome Measures

Changes in pain after the treatment program [Baseline, one week after the last sessio, 3 months and 6 months after the last session]
Numerical Pain Rating Scale (NPRS)
Changes in pressure pain sensitivity [Pre, Post inmediate, and follow-up at 3 and 6 months]
Pressure Pain Thresholds (PPH)
Changes in Quality of Life [Baseline, one week after the last sessio, 3 months and 6 months after the last session]
SF12 Health Status Questionnaire
Changes in Range of Motion [Baseline, one week after the last sessio, 3 months and 6 months after the last session]
Goniometer

Other Outcome Measures

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]
Ultrasound Shear-Wave elastography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Francisco de Vitoria University	Pozuelo de Alarcón	Madrid	Spain	28223

Sponsors and Collaborators

Universidad Francisco de Vitoria

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: Pablo Terrón-Manrique, PhD, Francisco de Vitoria University, Madrid, Spain