NCT06828081

Brief Summary

This research will use a randomized clinical trial (RCT) method to get military athletes with rotator cuff tendinopathy. People will be chosen at random to either get the GRASP method or normal exercises for making the shoulder muscles stronger. The main things the investigator will look at are how bad the pain is how well the shoulder works and if they can go back to work or sports. Tests will be done at the start, right after a treatment, and later times to measure the short-term and long-term advantages of the treatments. This study's careful way of doing things aims to provide strong information for military sports medicine. It helps doctors in treating shoulder problems like rotator cuff tendinopathy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

April 24, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

November 18, 2024

Last Update Submit

February 10, 2025

Conditions

Keywords

Rotator cuff tendinopathyGRASP trailsMilitary sportsShoulder pain

Outcome Measures

Primary Outcomes (3)

  • Western Ontario Rotator Cuff Index (WORC)

    The Western Ontario Rotator Cuff Index (WORC) is a self-reported questionnaire that evaluates the quality of life in individuals with rotator cuff disorders across five domains: physical signs and symptoms, sports, work, manner of living, and feelings. It ranges from 0 to 2100, and the lower the total, the better the result.

    5-6weeks

  • Inclinometer

    The inclinometer calculates shoulder R.O.M. in degrees with high accuracy. These are flexion: 170-180° rotation, abduction: 170-180°, external rotation: 90°, and internal rotation: 70-90°.

    5-6weeks

  • Push-Up Plus Test

    The Push-Up Plus Test is designed to assess both scapular stability and serratus anterior muscle strength from the observed scapular movements during the 'plus' action in a push-up formation. They are either pass/fail scores or quantitative repet

    5-6weeks

Study Arms (2)

Range of Motion Exercises

EXPERIMENTAL

Will get standard shoulder muscle exercises, including rigid and stretchy ones with bands that offer resistance.

Other: Range of Motion Exercises

Strengthening exercises with theraband

EXPERIMENTAL

They will go through the GRASP method, which involves special workouts just for them, teaching them about their health and ways to deal with pain.

Other: Strengthening exercises with theraband

Interventions

Will get standard shoulder muscle exercises, including rigid and stretchy ones with bands that offer resistance.

Range of Motion Exercises

They will go through the GRASP method, which involves special workouts just for them, teaching them about their health and ways to deal with pain.

Strengthening exercises with theraband

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • People in the military who are between 18 and 50 years old.
  • Active participation in sports activities for the military.
  • Diagnosing rotator cuff tendon pain in medical practice.
  • Basic shoulder movement within a certain range of motion.

You may not qualify if:

  • History of shoulder surgery.
  • Systemic inflammatory diseases.
  • Disorders of the brain or mind that affect physical actions.
  • Not being able to stick to the plan for later.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (10)

  • Abufoul R, Gavish L, Haddad M. Photobiomodulation self-treatment at home after rotator cuff arthroscopic repair accelerates improvement in pain, functionality, and quality of life: A double-blind, sham-controlled, randomized clinical trial. Lasers Surg Med. 2023 Sep;55(7):662-673. doi: 10.1002/lsm.23692. Epub 2023 Jun 8.

    PMID: 37288499BACKGROUND
  • Cools AM, Maenhout AG, Vanderstukken F, Decleve P, Johansson FR, Borms D. The challenge of the sporting shoulder: From injury prevention through sport-specific rehabilitation toward return to play. Ann Phys Rehabil Med. 2021 Jul;64(4):101384. doi: 10.1016/j.rehab.2020.03.009. Epub 2020 Apr 29.

    PMID: 32320753BACKGROUND
  • AlAnazi A, Alghadir AH, Gabr SA. Handgrip Strength Exercises Modulate Shoulder Pain, Function, and Strength of Rotator Cuff Muscles of Patients with Primary Subacromial Impingement Syndrome. Biomed Res Int. 2022 Aug 30;2022:9151831. doi: 10.1155/2022/9151831. eCollection 2022.

    PMID: 36082154BACKGROUND
  • Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26.

    PMID: 23893418BACKGROUND
  • Camargo PR, Alburquerque-Sendin F, Salvini TF. Eccentric training as a new approach for rotator cuff tendinopathy: Review and perspectives. World J Orthop. 2014 Nov 18;5(5):634-44. doi: 10.5312/wjo.v5.i5.634. eCollection 2014 Nov 18.

    PMID: 25405092BACKGROUND
  • Schedler S, Brueckner D, Hagen M, Muehlbauer T. Effects of a Traditional versus an Alternative Strengthening Exercise Program on Shoulder Pain, Function and Physical Performance in Individuals with Subacromial Shoulder Pain: A Randomized Controlled Trial. Sports (Basel). 2020 Apr 13;8(4):48. doi: 10.3390/sports8040048.

    PMID: 32294940BACKGROUND
  • Bourke J, Skouteris H, Hatzikiriakidis K, Fahey D, Malliaras P. Use of Behavior Change Techniques Alongside Exercise in the Management of Rotator Cuff-Related Shoulder Pain: A Scoping Review. Phys Ther. 2022 Apr 1;102(4):pzab290. doi: 10.1093/ptj/pzab290.

    PMID: 34972867BACKGROUND
  • Jones BH, Canham-Chervak M, Sleet DA. An evidence-based public health approach to injury priorities and prevention recommendations for the u.s. Military. Am J Prev Med. 2010 Jan;38(1 Suppl):S1-10. doi: 10.1016/j.amepre.2009.10.001.

    PMID: 20117582BACKGROUND
  • Jones A, Sealey R, Crowe M, Gordon S. Concurrent validity and reliability of the Simple Goniometer iPhone app compared with the Universal Goniometer. Physiother Theory Pract. 2014 Oct;30(7):512-6. doi: 10.3109/09593985.2014.900835. Epub 2014 Mar 25.

    PMID: 24666408BACKGROUND
  • Keene DJ, Soutakbar H, Hopewell S, Heine P, Jaggi A, Littlewood C, Hansen Z, Barker K, Hamilton W, Carr AJ, Lamb SE. Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the 'Getting it Right: Addressing Shoulder Pain' (GRASP) trial. Physiotherapy. 2020 Jun;107:252-266. doi: 10.1016/j.physio.2019.07.002. Epub 2019 Jul 9.

    PMID: 32026827BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Faiza Islam, DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

February 14, 2025

Study Start

April 24, 2024

Primary Completion

November 10, 2024

Study Completion

February 25, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations