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Shoulder Impingement SyndromeNCT06081088

Graded Motor Imagery Training in Shoulder Impingement Syndrome

A study testing Graded Motor Imagery (GMI) training, Conventional Physiotherapy and Home Exercise Program in people with Shoulder Impingement Syndrome and Pain, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Shoulder Impingement Syndrome, Pain
What is being tested?
Graded Motor Imagery (GMI) training, Conventional Physiotherapy and Home Exercise Program
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Oct 2023to 27 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

  • 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,
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, Başıbüyük, Süreyyapaşa Başıbüyük Yolu Sk No:4/B, 34854 Maltepe, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of Graded Motor Imagery Training in Patients With Shoulder Impingement Syndrome

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.

Read the detailed description

In this study 42 voluntary patients with Shoulder Impingement Syndrome, aged between 25-65 years will be randomly divided into two groups; group1: "GMI + Conventional Physiotherapy", group 2: "Conventional Physiotherapy".

All participants will receive treatment with a physiotherapist three times a week for six-weeks (18 sessions). At the end of the 6th week, it will be followed regularly with a six-week home exercise program. It will be evaluated by a physiotherapist three times in total (before treatment, at the end of six-weeks of treatment and after six-weeks of follow-up). In addition, all patients will undergo an interim evaluation in terms of primary outcome measures (VAS and DASH score) at week three. The shoulder pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS), Joint Range of Motion (ROM) will be measured with digital goniometer, strength of shoulder flexor, abductor, external and internal rotator muscles will be assessed with digital dynamometer, functional status will be evaluated with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, functional status of the hand will be evaluated with Jebsen-Taylor Hand Function Test (JTHFT), lateralization evaluation will be assessed with the Recognise™ application (Shoulder and Hand), and motor imagery will be evaluated with the Kinesthetic and Visual Imagery Questionnair (KVIQ). Patient satisfaction will be evaluated by the Global Rating of Change scale.

Being tested
Graded Motor Imagery (GMI) training, Conventional Physiotherapy, Home Exercise Program
Keywords
Shoulder Impingement Syndrome, Mirror Neurons, Pain, Functional Status, Rehabilitation
Medical subject headings
Shoulder Impingement Syndrome, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Graded Motor Imagery (GMI) trainingOther

    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).

  • Conventional PhysiotherapyOther

    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).

  • Home Exercise ProgramOther

    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).

Study groups in NCT06081088
Study groupRoleWhat they receive
Group 1ExperimentalStudy 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
Receives: Other: Graded Motor Imagery (GMI) training; Other: Conventional Physiotherapy; Other: Home Exercise Program
Group 2Active comparatorControl 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
Receives: Other: Conventional Physiotherapy; Other: Home Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (6)
  1. Active Range Of Motion (AROM)

    A digital goniometer will be used to measure shoulder active joint range of motion. While the patient is lying in the supine position, shoulder active flexion, active abduction, and then shoulder internal (internal) and external (external) rotation ROM measurements will be made with the shoulder in 90 degrees abduction and the elbow in 90 degrees flexion.

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

  2. Isometric Muscle Strength

    Isometric muscle strength of shoulder flexor, abductor, external and internal rotator muscles will be evaluated with a hand-held dynamometer. During muscle strength evaluation, patients will be asked to perform maximal voluntary isometric contraction while in a sitting position. Measurements will be repeated 3 times (5 seconds of contraction followed by 30 seconds of rest) for the affected side and the average of the 3 measurements will be taken and the resulting value will be recorded in kilograms (kg).

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

  3. Functional Status Of the Hand

    Jebsen-Taylor Hand Function Test (JTHFT) will be used to evaluate the functional status of the hand. JTHFT is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living. The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects. Time will be recorded in this test. Except for writing, other tasks are done separately with both hands. The completion time of the tasks refers to the subtask scores and total score of JTHFT. The total score is obtained by adding up the completion time of the six tasks other than writing for the dominant and non-dominant hands.

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

  4. Left/right discrimination (Lateralization)

    Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".

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

  5. Kinesthetic and Visual Imagery Questionnaire (KVIQ)

    Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.

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

  6. Global Rating of Change scale (Patient Satisfaction)

    Patient satisfaction regarding improvement in shoulder function will be evulated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.

    Measured: After the six-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start16 Oct 2023
  3. Primary completion27 Jun 2024
  4. Study completion27 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06081088
Sponsor's protocol ID
Marmara Uni.
Status last verified
Oct 2023
First submitted
2 Oct 2023
Last updated
28 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32003812
  • 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.

    PubMed 29257926
  • 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.

    PubMed 28483657
  • 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.

    PubMed 17082465

Questions about this trial

What is this clinical trial studying?

A study testing Graded Motor Imagery (GMI) training, Conventional Physiotherapy and Home Exercise Program in people with Shoulder Impingement Syndrome and Pain, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: Baseline, Interim evaluation (At the end of the 3rd week), After the six-week intervention, After six-weeks of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06081088, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.

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