NCT06865001

Brief Summary

Purpose: This randomized controlled trial aims to investigate the effects of Graded Motor Imagery (GMI) added to conventional physiotherapy in patients with Grade-2 shoulder impingement syndrome. The primary objectives are to evaluate the impact of GMI on pain intensity, range of motion, kinesiophobia, joint position sense, and quality of life. The hypotheses tested are: H0: GMI combined with conventional therapy has no effect on the aforementioned outcomes. H1: GMI combined with conventional therapy significantly improves these outcomes. Methodology: The study will include 30 participants (15 control, 15 intervention) diagnosed with Grade-2 shoulder impingement, recruited from a tertiary hospital. Participants will be randomly allocated into two groups: Control Group: Receives 15 sessions of conventional physiotherapy (ultrasound, TENS, hotpack, and therapeutic exercises). Intervention Group: Receives conventional therapy plus GMI, which includes three phases: (1) lateralization training (identifying left/right limb images), (2) motor imagery (mental rehearsal of functional movements), and (3) mirror therapy (visual feedback via mirror). Outcome measures include pain (Visual Analog Scale), range of motion (digital goniometer), joint position sense (mobile app-based assessment), kinesiophobia (Tampa Scale), upper extremity function (DASH questionnaire), and quality of life (SF-36). Pre- and post-intervention evaluations will be conducted.

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 Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

March 4, 2025

Last Update Submit

March 9, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    In this study, the severity of shoulder pain will be evaluated with the Visual Analogue Scale. According to the VAS, pain intensity is graded as "no pain" 0 points and "worst unbearable pain" 10 points (10 cm scale).

    3 weeks

  • Range of motion

    In the study, a digital goniometer, which has been validated and reliable, was used to objectively evaluate the normal range of motion of the shoulder. Normal range of motion of the shoulder will be evaluated by measuring the range of motion of shoulder flexion, extension, abduction, internal rotation and external rotation movements.

    3 weeks

  • Joint position sense

    In this study, using this mobile application, the patient will perform 50-70-90 and 110 degrees of shoulder flexion with eyes open. Then, the patient will be asked to position the arm at the same angles with the eyes closed. Then the degrees of deviation will be calculated.

    3 weeks

Secondary Outcomes (3)

  • The Short Form-36 Quality of Life Questionnaire

    3 weeks

  • Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH):

    3 weeks

  • TAMPA Kinesiophobia Scale

    3 weeks

Study Arms (2)

Intervention

OTHER

For patients diagnosed with shoulder impingemet, graded motor imagery will be applied in addition to 15 sessions of conventional treatment.

Other: Conventional treatmentOther: Graded motor imagery

Control

OTHER

Patients diagnosed with shoulder impingemet will receive 15 sessions of conventional treatment.

Other: Conventional treatment

Interventions

Ultrasound, hotpack and TENS will be applied to both control and study groups as physical therapy modality. Then 15 sessions of Codman exercises, normal range of motion exercises and stretching exercises will be applied to both groups.

ControlIntervention

Graded motor imagery consists of three stages: 1. limb lateralization task 2. an imaginary limb movement task (motor imagery) and 3. mirror therapy. Each session will consist of 12-15 minutes and 3 sets, with 5 minutes between sessions to rest and relax the limb. The application is planned for 30 minutes.

Intervention

Eligibility Criteria

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

You may qualify if:

  • To be between the ages of 18-65,
  • Volunteering to participate in the study,
  • Diagnosed with Grade-2 shoulder impingement.

You may not qualify if:

  • Not volunteering to participate in the study,
  • Having undergone upper extremity surgery,
  • History of previous shoulder surgery, shoulder subluxation or dislocation,
  • Any mental or sensory problems,
  • Acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation,

Balıkesir, Bandırma, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Associate Professor

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 7, 2025

Study Start

January 12, 2024

Primary Completion

May 30, 2025

Study Completion

July 30, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations