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

Rotator Cuff Tendinosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613998
• Other study ID #: RPGEI
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2022
• Source: Universidad Francisco de Vitoria
• Contact: Javier Alvarez-González
• Phone: +34629483292
• Email: j.alvarezglez.prof[@]ufv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tendinosis
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
Spain	Francisco de Vitoria University	Pozuelo de Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

References & Publications (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. — View 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. — View 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. — View Citation

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. Erratum in: Pain 1996 Mar;64(3):603. — View 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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in stifness (cervical plexus, radial nerve, supraespinatus and infraespinatus muscles)	Ultrasound Shear-Wave elastography	Baseline, one week after the last sessio, 3 months and 6 months after the last session
Primary	Changes in pain and disability after the treatment program	Shoulder Pain and Disability Index (SPADI)	Baseline, one week after the last sessio, 3 months and 6 months after the last session
Primary	Changes in pain and disability after the treatment program	The Disabilities of the Arm, Shoulder and Hand (Quick-DASH)	Baseline, one week after the last sessio, 3 months and 6 months after the last session
Secondary	Changes in pain after the treatment program	Numerical Pain Rating Scale (NPRS)	Baseline, one week after the last sessio, 3 months and 6 months after the last session
Secondary	Changes in pressure pain sensitivity	Pressure Pain Thresholds (PPH)	Pre, Post inmediate, and follow-up at 3 and 6 months
Secondary	Changes in Quality of Life	SF12 Health Status Questionnaire	Baseline, one week after the last sessio, 3 months and 6 months after the last session
Secondary	Changes in Range of Motion	Goniometer	Baseline, one week after the last sessio, 3 months and 6 months after the last session