Carpal Tunnel Syndrome (CTS)NCT07800260
Graded Motor Imagery in Carpal Tunnel Syndrome
A study testing Graded Motor Imagery (GMI), Progressive Neurodynamic Exercise and Nighttime Resting Splint in people with Carpal Tunnel Syndrome (CTS), run by Artvin Coruh University.
Trial summary
The aim of this study is to investigate whether the addition of Graded Motor Imagery (GMI) to progressive neurodynamic exercises is more effective than progressive neurodynamic exercises alone in individuals with carpal tunnel syndrome (CTS). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Graded Motor Imagery (GMI), Progressive Neurodynamic Exercise and Nighttime Resting Splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mild to moderate unilateral CTS based on the Bland classification of electrodiagnostic testing ;
- positive Phalen or Tinel tests;
- symptoms such as paresthesia and pain associated with CTS that last longer than 3 months;
- patients aged 30-60 years (when CTS becomes more prevalent);
- patients who achieved a minimum score of 24 on the Mini-Mental State Examination (MMSE).
Who cannot join
- bilateral CTS;
- history of prior CTS surgery;
- clinical indicators of cervical radiculopathy or polyneuropathy;
- pregnancy or cognitive impairment;
- the presence of orthopedic, neurological, or functional problems on the unaffected side that could affect hand function (e.g., history of trauma or surgery, peripheral nerve injury, tendinopathy, tenosynovitis, trigger finger, arthritis, sequelae of a fracture, etc.);
- receipt of any conservative treatment for CTS within the last month.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Is There an Advantage to Incorporating a Central Nervous System-targeted Intervention Within an Exercise Program for Individuals Diagnosed With Carpal Tunnel Syndrome? A Randomized Controlled Trial
The aim of this study is to investigate whether the addition of Graded Motor Imagery (GMI) to progressive neurodynamic exercises is more effective than progressive neurodynamic exercises alone in individuals with carpal tunnel syndrome (CTS). The objectives are to reduce pain and symptom severity, improve pain, sensorimotor function, physical performance, and grip strength through the addition of GMI.
Read the detailed description
46 voluntary patients with CTS, aged between 30-60 years will be randomly divided into two groups: GMI and progressive neurodynamic exercise group. Interventions will be applied for 6 weeks, 2 times a week (12 sessions). Both groups will receive progressive neurodynamic exercises and a nighttime resting splint. The GMI group will additionally receive Graded Motor Imagery, while the control group will receive no additional intervention. The patients will be assessed before, and after treatment. Upper extremity function and disability will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, cognitive status will be screened using the Mini-Mental State Examination (MMSE), and symptom severity and functional status related to CTS will be evaluated using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Sensory function will be assessed using the Semmes-Weinstein Monofilament Test and the Two-Point Discrimination Test, fine manual dexterity will be evaluated using the Purdue Pegboard Test, and hand grip strength will be measured using a Jamar hand dynamometer.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Graded Motor Imagery (GMI), Progressive Neurodynamic Exercise, Nighttime Resting Splint
- Keywords
- carpal tunnel syndrome, wrist joint, exercise, hand strength, physical functional performance
- Medical subject headings
- Carpal Tunnel Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor Imagery (GMI)Other
GMI includes three stages. GMI program will span over 6 weeks. The first 2 weeks will focus on lateralization, followed by 2 weeks of motor imagery, and the final 2 weeks will involve mirror therapy.
Lateralization: Patients will be asked to differentiate whether the hands shown in the Recognise™ Hand application belongs to the right or left side of their body.
Motor Imagery: Patients will be instructed to imagine slowly and smoothly moving their affected extremities to the posture depicted in the photos in the Recognise™ Hand application and then returning to the starting position.
Mirror Therapy: Using a mirror measuring 300 x 300 x 300 mm³ placed between the upper extremities, patients will be instructed to progressively move only their unaffected extremity, then their affected extremity, and finally both extremities.
Progressive Neurodynamic ExerciseOther
The progressive neurodynamic exercises involved holding each position for 5 seconds. Each session included two sets of 10 repetitions (2×10). The treatment lasted for 30-minute sessions, conducted twice weekly over a total of 6 weeks.
Nighttime Resting SplintOther
The night splint was fitted with a wrist splint that keeps the wrist in a neutral position, permits finger flexion, maintains the wrist within a 0°-5° extension range, and ends just distal to the distal palmar crease.
| Study group | Role | What they receive |
|---|---|---|
| Graded Motor Imagery | Experimental | Each patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, progressive neurodynamic exercises, and nighttime resting splints. Receives: Other: Graded Motor Imagery (GMI); Other: Progressive Neurodynamic Exercise; Other: Nighttime Resting Splint |
| Progressive Neurodynamic Exercises | Active comparator | Each patient in the progressive neurodynamic exercises group will receive a treatment protocol consisting of progressive neurodynamic exercises and nighttime resting splints. Receives: Other: Progressive Neurodynamic Exercise; Other: Nighttime Resting Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand (DASH)
DASH is a 30-item self-report tool assessing upper-extremity disability and symptoms, including daily activities, pain, numbness, joint stiffness, weakness, sleep issues, and psychological effects. Examples include turning a doorknob, changing a light bulb, and cutting food. Scores range from 0 to 100; higher scores indicate more severe symptoms and impairment.
Measured: Baseline
Disabilities of the Arm, Shoulder, and Hand (DASH)
DASH is a 30-item self-report tool assessing upper-extremity disability and symptoms, including daily activities, pain, numbness, joint stiffness, weakness, sleep issues, and psychological effects. Examples include turning a doorknob, changing a light bulb, and cutting food. Scores range from 0 to 100; higher scores indicate more severe symptoms and impairment.
Measured: After the 6-week intervention
Secondary outcomes (12)
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Measured: Baseline
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Measured: After the 6-week intervention
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
A patient-reported assessment uses a 5-point Likert scale with two subscales: the 11-item Symptom Severity Scale (CTSQ-S) for symptom intensity like numbness and pain, and the 8-item Functional Status Scale (CTSQ-F) for ADL ability such as writing and dressing. Higher scores mean more severe symptoms and impairment. The BCTQ shows high reliability, validity, and sensitivity to clinical changes.
Measured: Baseline
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
A patient-reported assessment uses a 5-point Likert scale with two subscales: the 11-item Symptom Severity Scale (CTSQ-S) for symptom intensity like numbness and pain, and the 8-item Functional Status Scale (CTSQ-F) for ADL ability such as writing and dressing. Higher scores mean more severe symptoms and impairment. The BCTQ shows high reliability, validity, and sensitivity to clinical changes.
Measured: After the 6-week intervention
The Semmes-Weinstein Monofilament Test
The assessment used a monofilament test (0.49-0.96), known for high sensitivity in diagnosing CTS. Sensory thresholds were checked at the radial tips of the thumbs, index, middle, and ring fingers. The monofilament was applied perpendicularly to the dorsal finger pads with eyes closed and the wrist in a neutral position. Pressure was applied for 1 to 1.5 seconds until slight bending of the filament. Lower readings indicate better sensory function; higher readings suggest worse light touch perception. A gauge of 2.83 grams is the normal threshold, while 3.22 grams or higher indicates moderate-to-severe sensory impairment in CTS.
Measured: Baseline
The Semmes-Weinstein Monofilament Test
The assessment used a monofilament test (0.49-0.96), known for high sensitivity in diagnosing CTS. Sensory thresholds were checked at the radial tips of the thumbs, index, middle, and ring fingers. The monofilament was applied perpendicularly to the dorsal finger pads with eyes closed and the wrist in a neutral position. Pressure was applied for 1 to 1.5 seconds until slight bending of the filament. Lower readings indicate better sensory function; higher readings suggest worse light touch perception. A gauge of 2.83 grams is the normal threshold, while 3.22 grams or higher indicates moderate-to-severe sensory impairment in CTS.
Measured: After the 6-week intervention
Purdue Pegboard Test
The Purdue Pegboard consists of 50 holes in two columns, with pins, washers, and sleeves in four recesses at the top. Patients sat in front of the apparatus and performed four tests: the dominant hand, non-dominant hand, two-hand, and assembly test. For the hand tests, they inserted pins into holes with their hands for 30 seconds each; the two-hand test used both hands. In the assembly test, they placed materials in order: pin → washer → collars → washer within 60 seconds. Each test was repeated three times, and scores were averaged. This test assesses fine motor skills, coordination, finger dexterity, hand-eye coordination, and small object manipulation; lower scores indicate poorer hand skills.
Measured: Baseline
Purdue Pegboard Test
The Purdue Pegboard consists of 50 holes in two columns, with pins, washers, and sleeves in four recesses at the top. Patients sat in front of the apparatus and performed four tests: the dominant hand, non-dominant hand, two-hand, and assembly test. For the hand tests, they inserted pins into holes with their hands for 30 seconds each; the two-hand test used both hands. In the assembly test, they placed materials in order: pin → washer → collars → washer within 60 seconds. Each test was repeated three times, and scores were averaged. This test assesses fine motor skills, coordination, finger dexterity, hand-eye coordination, and small object manipulation; lower scores indicate poorer hand skills.
Measured: After the 6-week intervention
The Two-Point Discrimination Test
The two-point discrimination threshold was evaluated using an esthesiometer applied to the pulp of the thumb, index, and middle fingers. During the evaluation, participants' eyes remained closed, and light stimuli, consisting of either one or two points, were randomly presented along the longitudinal axis of the fingers. The procedure began at a distance of 5 mm, with 10 trials conducted at each specified interval. If the participant failed to achieve at least seven correct responses, the distance was increased by 1 mm, and the test was repeated. The discrimination threshold was defined as the smallest distance at which at least seven out of ten responses were correct. Testing was discontinued at a maximum distance of 15 mm, with values below 6 mm considered within normal limits.
Measured: Baseline
The Two-Point Discrimination Test
The two-point discrimination threshold was evaluated using an esthesiometer applied to the pulp of the thumb, index, and middle fingers. During the evaluation, participants' eyes remained closed, and light stimuli, consisting of either one or two points, were randomly presented along the longitudinal axis of the fingers. The procedure began at a distance of 5 mm, with 10 trials conducted at each specified interval. If the participant failed to achieve at least seven correct responses, the distance was increased by 1 mm, and the test was repeated. The discrimination threshold was defined as the smallest distance at which at least seven out of ten responses were correct. Testing was discontinued at a maximum distance of 15 mm, with values below 6 mm considered within normal limits.
Measured: After the 6-week intervention
Grip Strength
Grip strength was measured using a hand dynamometer. The participant sat comfortably with shoulder abducted, elbow at 90°, and forearm neutral. The wrist was between 0° and 30° extension. Each hand was tested three times with one-minute rests, and the average was recorded.
Measured: Baseline
Grip Strength
Grip strength was measured using a hand dynamometer. The participant sat comfortably with shoulder abducted, elbow at 90°, and forearm neutral. The wrist was between 0° and 30° extension. Each hand was tested three times with one-minute rests, and the average was recorded.
Measured: After the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Model description
- In this prospective study, two treatment groups will be formed: a GMI group and a control group. Both groups will receive progressive neurodynamic exercises and a nighttime resting splint, while the GMI group will additionally receive Graded Motor Imagery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yıldız Kızkın, Artvin Coruh University
- Investigators
- Zeynep Yıldız Kızkın, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800260
- Sponsor's protocol ID
- Graded Motor Imagery in CTS
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Advantage to Incorporating a Central Nervous System-targeted Intervention Within an Exercise Program for Individuals Diagnosed With Carpal Tunnel Syndrome? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07800260
- Acronym / sponsor ID
- Graded Motor Imagery in CTS
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- carpal tunnel syndrome, wrist joint, exercise, hand strength, physical functional performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
The aim of this study is to investigate whether the addition of Graded Motor Imagery (GMI) to progressive neurodynamic exercises is more effective than progressive neurodynamic exercises alone in individuals with carpal tunnel syndrome (CTS). The objectives are to reduce pain and symptom severity, improve pain, sensorimotor function, physical performance, and grip strength through the addition of GMI.
Detailed description
46 voluntary patients with CTS, aged between 30-60 years will be randomly divided into two groups: GMI and progressive neurodynamic exercise group. Interventions will be applied for 6 weeks, 2 times a week (12 sessions). Both groups will receive progressive neurodynamic exercises and a nighttime resting splint. The GMI group will additionally receive Graded Motor Imagery, while the control group will receive no additional intervention. The patients will be assessed before, and after treatment. Upper extremity function and disability will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, cognitive status will be screened using the Mini-Mental State Examination (MMSE), and symptom severity and functional status related to CTS will be evaluated using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Sensory function will be assessed using the Semmes-Weinstein Monofilament Test and the Two-Point Discrimination Test, fine manual dexterity will be evaluated using the Purdue Pegboard Test, and hand grip strength will be measured using a Jamar hand dynamometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In this prospective study, two treatment groups will be formed: a GMI group and a control group. Both groups will receive progressive neurodynamic exercises and a nighttime resting splint, while the GMI group will additionally receive Graded Motor Imagery.
| Arm | Type | Receives |
|---|---|---|
| Graded Motor Imagery | Experimental | Other: Graded Motor Imagery (GMI), Other: Progressive Neurodynamic Exercise, Other: Nighttime Resting SplintEach patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, progressive neurodynamic exercises, and nighttime resting splints. |
| Progressive Neurodynamic Exercises | Active comparator | Other: Progressive Neurodynamic Exercise, Other: Nighttime Resting SplintEach patient in the progressive neurodynamic exercises group will receive a treatment protocol consisting of progressive neurodynamic exercises and nighttime resting splints. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- mild to moderate unilateral CTS based on the Bland classification of electrodiagnostic testing ;
- positive Phalen or Tinel tests;
- symptoms such as paresthesia and pain associated with CTS that last longer than 3 months;
- patients aged 30-60 years (when CTS becomes more prevalent);
- patients who achieved a minimum score of 24 on the Mini-Mental State Examination (MMSE).
Key exclusion criteria (6 listed)
- bilateral CTS;
- history of prior CTS surgery;
- clinical indicators of cervical radiculopathy or polyneuropathy;
- pregnancy or cognitive impairment;
- the presence of orthopedic, neurological, or functional problems on the unaffected side that could affect hand function (e.g., history of trauma or surgery, peripheral nerve injury, tendinopathy, tenosynovitis, trigger finger, arthritis, sequelae of a fracture, etc.);
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 Imagery (GMI)GMI includes three stages. GMI program will span over 6 weeks. The first 2 weeks will focus on lateralization, followed by 2 weeks of motor imagery, and the final 2 weeks will involve mirror therapy. Lateralization: Patients will be asked to differentiate whether the hands shown in the Recognise™ Hand application belongs to the right or left side of their body. Motor Imagery: Patients will be instructed to imagine slowly and smoothly moving their affected extremities to the posture depicted in the photos in the Recognise™ Hand application and then returning to the starting position. Mirror Therapy: Using a mirror measuring 300 x 300 x 300 mm³ placed between the upper extremities, patients will be instructed to progressively move only their unaffected extremity, then their affected extremity, and finally both extremities. | Other | Graded Motor Imagery |
| Progressive Neurodynamic ExerciseThe progressive neurodynamic exercises involved holding each position for 5 seconds. Each session included two sets of 10 repetitions (2×10). The treatment lasted for 30-minute sessions, conducted twice weekly over a total of 6 weeks. | Other | Graded Motor Imagery, Progressive Neurodynamic Exercises |
| Nighttime Resting SplintThe night splint was fitted with a wrist splint that keeps the wrist in a neutral position, permits finger flexion, maintains the wrist within a 0°-5° extension range, and ends just distal to the distal palmar crease. | Other | Graded Motor Imagery, Progressive Neurodynamic Exercises |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: Baseline
DASH is a 30-item self-report tool assessing upper-extremity disability and symptoms, including daily activities, pain, numbness, joint stiffness, weakness, sleep issues, and psychological effects. Examples include turning a doorknob, changing a light bulb, and cutting food. Scores range from 0 to 100; higher scores indicate more severe symptoms and impairment.
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: After the 6-week intervention
DASH is a 30-item self-report tool assessing upper-extremity disability and symptoms, including daily activities, pain, numbness, joint stiffness, weakness, sleep issues, and psychological effects. Examples include turning a doorknob, changing a light bulb, and cutting food. Scores range from 0 to 100; higher scores indicate more severe symptoms and impairment.
12 secondary outcomes
Mini Mental State Examination
Time frame: Baseline
Mini Mental State Examination
Time frame: After the 6-week intervention
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time frame: Baseline
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time frame: After the 6-week intervention
The Semmes-Weinstein Monofilament Test
Time frame: Baseline
The Semmes-Weinstein Monofilament Test
Time frame: After the 6-week intervention
Purdue Pegboard Test
Time frame: Baseline
Purdue Pegboard Test
Time frame: After the 6-week intervention
The Two-Point Discrimination Test
Time frame: Baseline
The Two-Point Discrimination Test
Time frame: After the 6-week intervention
Grip Strength
Time frame: Baseline
Grip Strength
Time frame: After the 6-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Zeynep Yıldız Kızkın principal investigator
Artvin Coruh University
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery (GMI), Progressive Neurodynamic Exercise and Nighttime Resting Splint in people with Carpal Tunnel Syndrome (CTS), run by Artvin Coruh University.
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 6 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Yıldız Kızkın (+905346945085, pt.zeynepyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand (DASH) (time frame: Baseline). 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?
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 2 Sep 2026.