NCT06702319

Brief Summary

This study aims to evaluate the effectiveness of externally focused shoulder stabilization exercises on range of motion, pain, handgrip strength, and proprioception in patients with rotator cuff tendinopathy. For the study, 69 patients will be randomly divided into three groups: Home Program Group (HPG), Internal Focused Exercise Group (IFEG), and External Focused Exercise Group (EFEG). The treatment period for all three groups will be 6 weeks. Shoulder range of motion, pain, handgrip strength, joint position sense, and shoulder function (WORC and QuickDASH) of the three groups will be evaluated at baseline and after intervention. IFEG will do the exercises with a physiotherapist twice a week. During the exercise, the patient will be allowed to focus on the body parts while performing the movement. EFEG will do the exercises with a physiotherapist twice a week. The patient will be allowed to focus on a point outside the body, namely the effect of the movement, during the exercise. In the management of HPG patients will be provided with an exercise brochure. At the conclusion of the study, the three groups will be compared and evaluated using appropriate statistical analyses to assess the outcomes and determine any significant differences between them.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

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

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 14, 2024

Last Update Submit

November 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quick Disabilities of Arm, Shoulder & Hand

    The Quick Disabilities of Arm, Shoulder \& Hand Index is used to measure upper extremity physical function. A Turkish validity and reliability study has been conducted. The scale includes 11 headings extracted from the long version. Each question consists of a 5-point scale. The total score is calculated with the formula \[(sum of n responses) /n-1\] ×25, where n= indicates the total number of questions answered. The total score varies between 0 (no disability) and 100 (severe disability). The final score is classified as; 0- 15: 'no problem', 16-40: 'problem but able to work', 40 and above: 'unable to work'.

    one day before the intervention and 6 weeks after

Secondary Outcomes (5)

  • Shoulder Joint Range of Motion

    one day before the intervention and 6 weeks after

  • Assessment of Shoulder Pain

    one day before the intervention and 6 weeks after

  • Western Ontario Rotator Cuff (WORC) Index

    one day before the intervention and 6 weeks after

  • Assessment of Hand Grip Strength:

    one day before the intervention and 6 weeks after

  • Assessment of Joint Position Sense:

    one day before the intervention and 6 weeks after

Study Arms (3)

home exercise program

NO INTERVENTION

A total of at least 23 Participants will receive the home exercise program for 6 weeks.

internal focus exercise program

EXPERIMENTAL

A total of at least 23 Participants will receive the internal focus exercise program for 6 weeks.

Other: Exercise

external focus exercise program

EXPERIMENTAL

A total of at least 23 Participants will receive the external focus exercise program for 6 weeks.

Other: Exercise

Interventions

Home exercises and home exercises with internal focus exercises or external focus exercises

external focus exercise programinternal focus exercise program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a diagnosis of rotator cuff tendinopathy,
  • Having sufficient cooperation to perform the exercises.

You may not qualify if:

  • Having a neurological problem,
  • Having a previous fracture in the shoulder region,
  • Having undergone a relevant surgery in the past,
  • Having any chronic illness that could prevent exercise (e.g., chronic heart failure, pacemaker, etc.),
  • Having a systemic condition that could affect proprioception, such as diabetes, rheumatoid arthritis, ankylosing spondylitis, or advanced osteoarthritis,
  • Having received a physiotherapy program targeting the neck and upper extremity within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, Turkey (Türkiye)

Location

Related Publications (16)

  • Chaudhury S, Gwilym SE, Moser J, Carr AJ. Surgical options for patients with shoulder pain. Nat Rev Rheumatol. 2010 Apr;6(4):217-26. doi: 10.1038/nrrheum.2010.25.

    PMID: 20357791BACKGROUND
  • Kibler WB. Rehabilitation of rotator cuff tendinopathy. Clin Sports Med. 2003 Oct;22(4):837-47. doi: 10.1016/s0278-5919(03)00048-6.

    PMID: 14560550BACKGROUND
  • Arnocky SP, Lavagnino M, Egerbacher M. The Response of Tendon Cells to Changing Loads: Implications in the Etiopathogenesis of Tendinopathy. In: Woo L-Y, Renström AFH, Arnoczky SP, editors. Tendinopathy in athletes. Oxford, UK: Wiley online library; 2007. pp. 46-59.

    BACKGROUND
  • 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
  • Wulf G, Hoss M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334.

    PMID: 20037032BACKGROUND
  • Wulf G, Lewthwaite R. Optimizing performance through intrinsic motivation and attention for learning: The OPTIMAL theory of motor learning. Psychon Bull Rev. 2016 Oct;23(5):1382-1414. doi: 10.3758/s13423-015-0999-9.

    PMID: 26833314BACKGROUND
  • Wulf G, Weigelt M, Poulter D, McNevin N. Attentional focus on suprapostural tasks affects balance learning. Q J Exp Psychol A. 2003 Oct;56(7):1191-211. doi: 10.1080/02724980343000062.

    PMID: 12959910BACKGROUND
  • Park SH, Yi CW, Shin JY, Ryu YU. Effects of external focus of attention on balance: a short review. J Phys Ther Sci. 2015 Dec;27(12):3929-31. doi: 10.1589/jpts.27.3929. Epub 2015 Dec 28.

    PMID: 26834382BACKGROUND
  • Castillo-Vejar L, Lizama-Fuentes M, Bascour-Sandoval C, Cuyul-Vasquez I. [Attentional focus instructions for therapeutic exercise in people with musculoskeletal disorders. A scoping review]. Rehabilitacion (Madr). 2022 Oct-Dec;56(4):344-352. doi: 10.1016/j.rh.2021.11.006. Epub 2022 Apr 22. Spanish.

    PMID: 35469643BACKGROUND
  • Lohse KR, Sherwood DE. Defining the focus of attention: effects of attention on perceived exertion and fatigue. Front Psychol. 2011 Nov 14;2:332. doi: 10.3389/fpsyg.2011.00332. eCollection 2011.

    PMID: 22102843BACKGROUND
  • Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.

  • Bertelsen TI. [Visual coordination- and accommodation disturbances and eye diseases as causes of headache]. Nord Med. 1978 Apr;93(3-4):57-8. No abstract available. Norwegian.

  • El O, Bircan C, Gulbahar S, Demiral Y, Sahin E, Baydar M, Kizil R, Griffin S, Akalin E. The reliability and validity of the Turkish version of the Western Ontario Rotator Cuff Index. Rheumatol Int. 2006 Oct;26(12):1101-8. doi: 10.1007/s00296-006-0151-2. Epub 2006 Jun 24.

  • Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003 Mar;13(2):84-92. doi: 10.1097/00042752-200303000-00004.

  • Koldas Dogan S, Ay S, Evcik D, Baser O. Adaptation of Turkish version of the questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) in patients with carpal tunnel syndrome. Clin Rheumatol. 2011 Feb;30(2):185-91. doi: 10.1007/s10067-010-1470-y. Epub 2010 Apr 22.

  • Vafadar AK, Cote JN, Archambault PS. Interrater and Intrarater Reliability and Validity of 3 Measurement Methods for Shoulder-Position Sense. J Sport Rehabil. 2016 Feb 2;25(1):2014-0309. doi: 10.1123/jsr.2014-0309. Print 2016 Feb 1.

MeSH Terms

Conditions

Shoulder PainRotator Cuff Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Onur Engin, Assist Prof

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 22, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 15, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations