NCT06081088

Brief Summary

The aim of this study is to investigate the effects of Graded Motor Imagery (GMI) training on pain, functionality, disability and daily living activities in patients diagnosed with Shoulder Impingement Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

June 28, 2024

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 2, 2023

Last Update Submit

June 27, 2024

Conditions

Keywords

Shoulder Impingement SyndromeMirror NeuronsPainFunctional StatusRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Pain intensity will be assessed with Visual Analog Scale (VAS). The VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 \[100-mm scale\]) on the right side.The patient will be asked to mark the line point that represented his or her current pain.

    Baseline, Interim evaluation (At the end of the 3rd week), After the six-week intervention, After six-weeks of follow-up

  • Functional Status

    The disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used in shoulder functional status evaluation. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. 21 of the questions of the survey question the ability to perform functional activities, 5 question the pain, and 4 question the psychosocial effects of the disease. Each question is scored using a 5-point Likert scale ranging from 1 to 5 (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all). Higher scores indicate better functional status.

    Baseline, Interim evaluation (At the end of the 3rd week), After the six-week intervention, After six-weeks of follow-up

Secondary Outcomes (6)

  • Active Range Of Motion (AROM)

    Baseline, After the six-week intervention, After six-weeks of follow-up

  • Isometric Muscle Strength

    Baseline, After the six-week intervention, After six-weeks of follow-up

  • Functional Status Of the Hand

    Baseline, After the six-week intervention, After six-weeks of follow-up

  • Left/right discrimination (Lateralization)

    Baseline, After the six-week intervention, After six-weeks of follow-up

  • Kinesthetic and Visual Imagery Questionnaire (KVIQ)

    Baseline, After the six-week intervention, After six-weeks of follow-up

  • +1 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Study group: "Graded Motor Imagery Training + Conventional Physiotherapy" In this group, each participant will be received a treatment protocol consisting of Graded Motor Imagery training, conventional physiotherapy, and home exercises. * Graded Motor Imagery (GMI) * Conventional Physiotherapy Program * Home Exercise Program

Other: Graded Motor Imagery (GMI) trainingOther: Conventional PhysiotherapyOther: Home Exercise Program

Group 2

ACTIVE COMPARATOR

Control group: "Conventional Physiotherapy" In this group, each participant will be received a treatment protocol consisting of conventional physiotherapy, and home exercises. * Conventional Physiotherapy Program * Home Exercise Program

Other: Conventional PhysiotherapyOther: Home Exercise Program

Interventions

GMI consists of three basic components: 1. Left / Right Discrimination training (Lateralization training): For lateralization training, patients will be trained by asking them to distinguish between right and left with images taken at various angles and positions in the RecogniseTM (NOI-Australia) applications (shoulder and hand sections) (In weeks 1 and 2). 2. Motor Imagery (Explicit Motor Imagery): At this stage, the participant will be asked to imagine doing various functional activities (brushing teeth, combing hair, etc.) in the position they feel most comfortable in and in a quiet environment (In weeks 2 and 3). 3. Mirror Therapy (providing visual feedback through a mirror): In this phase, active ROM exercises and progressive resistance exercises with simultaneous movement of the affected and unaffected extremities will be applied using a standard size posture mirror (In weeks 3-6). This program will be applied for 6 weeks (3 sessions per week).

Group 1

Conventional physiotherapy program includes passive, active-assistive (wand exercises) and active ROM exercises for shoulder joint, passive / active posterior and anterior capsule stretching exercises, superior-inferior, mediolateral and distraction techniques for scapular mobilization exercises, shoulder flexion, abduction, internal and external rotation muscles strengthening exercises, static and dynamic stabilization exercises for proprioception exercises. To reduce the pain that may occur after exercises, cold application and Transcutaneous Electrical Nerve Stimulation (TENS) will be applied to benefit from their analgesic effects. Cold application will be applied around the shoulder using a coldpack (gel pack) cold therapy for 15 minutes. Conventional TENS application around shoulder will be performed using a TENS device and four separate 2 × 2 inch self-adhesive electrodes for 15 minutes.This program will be applied for 6 weeks (3 sessions per week).

Group 1Group 2

The home exercises program includes shoulder jonit active ROM exercises, active posterior and anterior shoulder capsule stretching exercises, shoulder flexion, abduction, internal and external rotation muscles strengthening exercises, shoulder proprioception exercises, and cold therapy. This program will be applied for 6 weeks (3 sessions per week).

Group 1Group 2

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 25-65 years old,
  • Having been diagnosed with Shoulder Impingement Syndrome by physical examination and MRI as a result of shoulder pain lasting at least 3 months,
  • Presence of a painful arc between 60° and 120° in shoulder flexion / abduction (elevation) movements,
  • The Standardized Mini Mental Test result must be at least 24 points,
  • Not having seen imagery practice before,

You may not qualify if:

  • Having severe mental and communication problems,
  • Having undergone surgical treatment on the same upper extremity,
  • Presence of acute trauma, peripheral nervous system lesion, fracture or complete tendon rupture in the affected shoulder,
  • Presence of other pathologies such as adhesive capsulitis of the shoulder joint complex and glenohumeral instability,
  • Presence of radiotherapy history on the same side as the affected shoulder,
  • Presence of congenital deformity,
  • Symptomatic cervical spine pathology,
  • Presence of other neurological or rheumatological disorders affecting upper motor function,
  • Having any chronic disease that would prevent participation in the treatment program,
  • Having attended a physiotherapy program within the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Başıbüyük, Süreyyapaşa Başıbüyük Yolu Sk No:4/B, 34854 Maltepe, 34854, Turkey (Türkiye)

Location

Related Publications (4)

  • Araya-Quintanilla F, Gutierrez-Espinoza H, Jesus Munoz-Yanez M, Rubio-Oyarzun D, Cavero-Redondo I, Martinez-Vizcaino V, Alvarez-Bueno C. The Short-term Effect of Graded Motor Imagery on the Affective Components of Pain in Subjects with Chronic Shoulder Pain Syndrome: Open-Label Single-Arm Prospective Study. Pain Med. 2020 Oct 1;21(10):2496-2501. doi: 10.1093/pm/pnz364.

    PMID: 32003812BACKGROUND
  • Sawyer EE, McDevitt AW, Louw A, Puentedura EJ, Mintken PE. Use of Pain Neuroscience Education, Tactile Discrimination, and Graded Motor Imagery in an Individual With Frozen Shoulder. J Orthop Sports Phys Ther. 2018 Mar;48(3):174-184. doi: 10.2519/jospt.2018.7716. Epub 2017 Dec 19.

    PMID: 29257926BACKGROUND
  • Louw A, Puentedura EJ, Reese D, Parker P, Miller T, Mintken PE. Immediate Effects of Mirror Therapy in Patients With Shoulder Pain and Decreased Range of Motion. Arch Phys Med Rehabil. 2017 Oct;98(10):1941-1947. doi: 10.1016/j.apmr.2017.03.031. Epub 2017 May 5.

    PMID: 28483657BACKGROUND
  • Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.

    PMID: 17082465BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • MASOUD AMIR RASHEDI BONAB, PhD

    Marmara 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
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 12, 2023

Study Start

October 16, 2023

Primary Completion

June 27, 2024

Study Completion

June 27, 2024

Last Updated

June 28, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations