Shoulder PainNCT06092502
Shoulder Impingement Syndrome and Graded Motor Imagery
A study testing Graded Motor Imagery and Traditional Physiotherapy Program in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Nuray Alaca at 1 site in Turkey (Türkiye).
Trial summary
Graded motor imagery (GMI): used successfully in chronic, complex and painful clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome
- What is being tested?
- Graded Motor Imagery and Traditional Physiotherapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2023to 13 Dec 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-50 years of age with complaints of shoulder pain in the anterio-lateral region lasting more than 6 weeks, with a positive Neer impingement test and/or a positive Hawkins-Kennedy test
- Additionally, patients must have at least one of the symptoms listed. These symptoms are: painful arch on active shoulder elevation, pain with resisted shoulder external rotation in abduction at 90°, and a positive empty can test.
Who cannot join
- Having had a steroid injection into the shoulder within the last 3 months
- Previous surgery on the neck, thoracic spine or shoulder
- Red flags (e.g. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, history of long-term steroid use)
- History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, frozen shoulder, or cervical or thoracic surgery
- History of full-thickness rotator cuff tear
- History of cervical disc herniation in the last 6 weeks
Show all 12Show fewer
- History of breast cancer on the involved side
- Isolated acromioclavicular joint pathology (i.e., pain directly localized over the acromioclavicular joint).
- Signs of cervical radiculopathy, radiculitis, or referred pain originating from the cervical spine
- Receiving treatment for shoulder pain in the last 3 months
- Being currently pregnant (Dunning, 2022)
- Scoring ≤24 on the Standardized Mini Mental Test was determined.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Shoulder Impingement Syndrome
Graded motor imagery (GMI): used successfully in chronic, complex and painful clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and approaches the individual holistically with a biopsychosocial model. Nowadays, it is frequently used in the treatment of some neurological diseases. In addition, these approaches are also used in the treatment of some orthopedic diseases including chronic pain. There are a limited number of studies in which the mentioned approaches are used together in stages, and the stages are mostly used alone. There is only one study in the literature on subacromial pain syndrome (SAS), which is the most common cause of shoulder pain and causes radiator cuff problems. Stage 2 SAS patients were included in the study and only one phase of GMI treatment was used in addition to the traditional physiotherapy program. Despite these positive results in favor of GMI, the fact that there is no study using the entire GMI treatment in SAS shows us that a randomized controlled and blinded study with high evidence value should be conducted on this subject. In addition, determining the effect of GMI on changes in central nervous system such as fear of pain, two-point discrimination, and left/right lateralization speed and accuracy task will help fill the literature gaps on this subject. In the light of this information, the question of planned master's thesis study is the effect of GMI treatment applied in addition to traditional physiotherapy in SAS on pain level, joint range of motion, functionality, pain-related fear, two-point discrimination and left/right lateralization speed and accuracy compared to only traditional physiotherapy. whether it is superior or not.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome
- Being tested
- Graded Motor Imagery, Traditional Physiotherapy Program
- Keywords
- Shoulder Pain, graded motor imagery
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor ImageryOther
Also called Traditional Physiotherapy Program
The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes.
Traditional Physiotherapy ProgramOther
This protocol included stretching and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physiotherapy Program | Active comparator | This group included strengthening exercises will be applied, including various joint movements and strengthening exercises applied in physiotherapy clinics. Receives: Other: Traditional Physiotherapy Program |
| Traditional Physiotherapy Program and Graded Motor Imagery Therapy | Experimental | The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes. Receives: Other: Graded Motor Imagery; Other: Traditional Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NPRS-11)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: Change from baseline range of motion at 6th week
The Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Measured: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
Global Rating of Change scale (Patient Satisfaction)
Patient satisfaction regarding improvement in shoulder function will be evaluated 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 between -3 to +3, with a higher value indicating better condition in this study.
Measured: Change from baseline Global Rating of Change scale at 6th week
Central Sensitization Scale
Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.
Measured: Change from baseline score of Central Sensitization Scale scale at 6th week
Secondary outcomes (7)
Range of motion
Shoulder range of motion is the capability of a joint to go through its complete spectrum of movements.
Measured: Change from baseline range of motion at 6th week
Pressure Pain Threshold
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Measured: Change from baseline Pressure Pain Threshold at 6th week
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.The person may score a total of 52 (Pain Catastrophizing Scale). A high score indicates a high level of catastrophic.
Measured: Change from baseline score of Pain Catastrophizing Scale at 6th week
Fear avoidance belief questionnaire (FABQ)
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Measured: Change from baseline score of Fear avoidance belief questionnaire at 6th week
The two-point discrimination test
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.
Measured: Change from baseline two-point discrimination at 6th week
Left/right discrimination (Lateralization)
Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".
Measured: Change from baseline Left/right discrimination at 6th week
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: Change from baseline Kinesthetic and Visual Imagery Questionnaire at 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start13 Oct 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuray Alaca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092502
- Sponsor's protocol ID
- ATADEK-2023/11
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06092502
- Acronym / sponsor ID
- ATADEK-2023/11
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome
- Keywords
- Shoulder Pain, graded motor imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nuray AlacaUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2025 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Graded motor imagery (GMI): used successfully in chronic, complex and painful clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and approaches the individual holistically with a biopsychosocial model. Nowadays, it is frequently used in the treatment of some neurological diseases. In addition, these approaches are also used in the treatment of some orthopedic diseases including chronic pain. There are a limited number of studies in which the mentioned approaches are used together in stages, and the stages are mostly used alone. There is only one study in the literature on subacromial pain syndrome (SAS), which is the most common cause of shoulder pain and causes radiator cuff problems. Stage 2 SAS patients were included in the study and only one phase of GMI treatment was used in addition to the traditional physiotherapy program. Despite these positive results in favor of GMI, the fact that there is no study using the entire GMI treatment in SAS shows us that a randomized controlled and blinded study with high evidence value should be conducted on this subject. In addition, determining the effect of GMI on changes in central nervous system such as fear of pain, two-point discrimination, and left/right lateralization speed and accuracy task will help fill the literature gaps on this subject. In the light of this information, the question of planned master's thesis study is the effect of GMI treatment applied in addition to traditional physiotherapy in SAS on pain level, joint range of motion, functionality, pain-related fear, two-point discrimination and left/right lateralization speed and accuracy compared to only traditional physiotherapy. whether it is superior or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physiotherapy Program | Active comparator | Other: Traditional Physiotherapy ProgramThis group included strengthening exercises will be applied, including various joint movements and strengthening exercises applied in physiotherapy clinics. |
| Traditional Physiotherapy Program and Graded Motor Imagery Therapy | Experimental | Other: Graded Motor Imagery, Other: Traditional Physiotherapy ProgramThe three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-50 years of age with complaints of shoulder pain in the anterio-lateral region lasting more than 6 weeks, with a positive Neer impingement test and/or a positive Hawkins-Kennedy test
- Additionally, patients must have at least one of the symptoms listed. These symptoms are: painful arch on active shoulder elevation, pain with resisted shoulder external rotation in abduction at 90°, and a positive empty can test.
Key exclusion criteria (12 listed)
- Having had a steroid injection into the shoulder within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Motor ImageryAlso: Traditional Physiotherapy ProgramThe three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes. | Other | Traditional Physiotherapy Program and Graded Motor Imagery Therapy |
| Traditional Physiotherapy ProgramThis protocol included stretching and strengthening exercises | Other | Traditional Physiotherapy Program, Traditional Physiotherapy Program and Graded Motor Imagery Therapy |
Primary outcome
The Numerical Rating Scale (NPRS-11)
Time frame: Change from baseline range of motion at 6th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
The Shoulder Pain and Disability Index
Time frame: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Global Rating of Change scale (Patient Satisfaction)
Time frame: Change from baseline Global Rating of Change scale at 6th week
Patient satisfaction regarding improvement in shoulder function will be evaluated 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 between -3 to +3, with a higher value indicating better condition in this study.
Central Sensitization Scale
Time frame: Change from baseline score of Central Sensitization Scale scale at 6th week
Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.
7 secondary outcomes
Range of motion
Time frame: Change from baseline range of motion at 6th week
Pressure Pain Threshold
Time frame: Change from baseline Pressure Pain Threshold at 6th week
Pain Catastrophizing Scale
Time frame: Change from baseline score of Pain Catastrophizing Scale at 6th week
Fear avoidance belief questionnaire (FABQ)
Time frame: Change from baseline score of Fear avoidance belief questionnaire at 6th week
The two-point discrimination test
Time frame: Change from baseline two-point discrimination at 6th week
Left/right discrimination (Lateralization)
Time frame: Change from baseline Left/right discrimination at 6th week
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: Change from baseline Kinesthetic and Visual Imagery Questionnaire at 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery and Traditional Physiotherapy Program in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Nuray Alaca 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 2 inclusion and 12 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 24 Jul 2026. 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?
The Numerical Rating Scale (NPRS-11) (time frame: Change from baseline range of motion at 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.