Carpal Tunnel SyndromeNCT07754708
The Effect of Carpal Tunnel Syndrome Phenotyping on Response to Treatment
A study testing Standard Rehabilitation Protocol in people with Carpal Tunnel Syndrome, run by Kutahya Health Sciences University.
Trial summary
The aim of this study was to evaluate the effect of Carpal Tunnel Syndrome (CTS) phenotyping on responsiveness to clinical interventions in individuals with CTS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Standard Rehabilitation Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2026to 27 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with CTS
- Being suitable for the neuropathic pain phenotype
- Being between the ages of 18-65
- Volunteering to participate in the study
Who cannot join
- Having systemic inflammatory disease
- Having a disease that may cause polyneuropathy such as diabetes mellitus
- Having a pacemaker
- Having a disease affecting the central nervous system
- Having cervical radiculopathy
- History of previous operation or local steroid injection due to CTS
- Hypersensitivity to heat and cold
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
The aim of this study was to evaluate the effect of Carpal Tunnel Syndrome (CTS) phenotyping on responsiveness to clinical interventions in individuals with CTS.
Read the detailed description
People between the ages of 18-65, diagnosed with Carpal Tunnel Syndrome, who are suitable for the Neuropathic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System for Carpal Tunnel Syndrome as defined by the International Association for the Study of Pain (IASP) will be applied to patients with CTS. After determining the dominant pain phenotype in patients with CTS, one group will consist of patients with homogeneous neuropathic pain phenotype (Group 1). The heterogeneous group will consist of patients with neuropathic and mixed pain phenotype (both neuropathic and nociplastic pain phenotype) (Group 2). Training, exercise, and wrist splinting will be applied to both groups. The training will include a presentation and booklet on the pathophysiology of CTS, treatment options (conservative treatment and surgery), posture and activity modification principles. Participants will be given a programme of median nerve sliding and tendon sliding exercises as home exercises. The numerical rating scale (NRS) scale will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale, Boston Carpal Tunnel Questionnaire - Functional Status Scale, Michigan Hand Results Questionnaire (MHQ) will be used. Normality of data distribution will be assessed using the Shapiro-Wilk test. Fisher's exact test and chi-square test will be used to verify the relationship between categorical variables. A mixed model ANOVA will be performed on 2 (group 1 and group 2) x 3 (time: baseline, week 6 and week 12) different outcome measures (pain intensity, symptom severity, functional status, Michigan Hand Results Questionnaire (MHQ)) to detect between-group differences.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Standard Rehabilitation Protocol
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Rehabilitation ProtocolOther
A comprehensive standard rehabilitation program consisting of patient education, application of a clinical splint, and a structured exercise.
| Study group | Role | What they receive |
|---|---|---|
| Homogeneous Neuropathic Phenotype | Experimental | Participants assigned to this arm present with a clinically determined, homogeneous neuropathic phenotype. All individuals in this group will receive a standard rehabilitation protocol consisting of patient education, splint application, and a structured exercise program. Receives: Other: Standard Rehabilitation Protocol |
| Heterogeneous Unclassified Phenotype | Active comparator | Participants assigned to this arm do not have a specifically classified neuropathic phenotype and present with heterogeneous characteristics. All individuals in this group will receive the same standard rehabilitation protocol consisting of patient education, splint application, and a structured exercise program. Receives: Other: Standard Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
Measured: Baseline, 6 weeks, 12 weeks
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale is an 11-item questionnaire used to assess symptom severity in individuals with CTS. Each item is scored from 1 to 5. Scores range from 1 (no symptoms) to 5 (worst symptoms). The patient's symptom severity score is the average score of 11 items.
Measured: Baseline, 6 weeks, 12 weeks
Boston Carpal Tunnel Questionnaire - Functional Status Scale
Boston Carpal Tunnel Questionnaire - Functional Status Scale is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.
Measured: Baseline, 6 weeks, 12 weeks
Michigan Hand Questionnaire (MHQ)
The Michigan Hand Questionnaire (MHQ) is a hand-specific questionnaire that measures the health status of patients with acute and chronic hand disorders. The MHQ is an outcome tool consisting of 37 questions and 6 domains: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with function. Each domain is scored using an unweighted method by summing the responses on each scale (1 to 5) and normalising the scores to a scale from 0 to 100. A lower score indicates more severe disability, other than pain. The final score is obtained by averaging the six scores after inverting the pain score.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (5)
Cold Pain Threshold
For cold pain threshold, ice cubes (-5°C) placed in a plastic bag will be placed on the patients' skin for 10 seconds. Increased sensory perception will be considered as gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: 2 minutes
Hot Pain Threshold
Thermal pain perception will be tested using a metal piece equal to (lab-QST thermode size). The metal parts will be heated to 45˚C for hot pain threshold. The metal pieces will be applied to the skin for 3 seconds. It will be determined whether the stimulus is painful (yes/no), and if painful, the intensity of the pain on a numerical rating scale (NRS) (0: no pain, 10: imaginably worse pain).
Measured: 2 minutes
Pressure Pain Threshold
A digital algometer will be used to measure Pressure Pain Threshold levels. Pressure will be applied at a rate of approximately 30 kPa/s with the algometer placed perpendicular to the point of application. Participants will be instructed to report when the sensation changes from pressure to pain. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).
Measured: 3 minutes
Mechanical Pain Threshold
Mechanical pain threshold: to be assessed with a toothpick and a von Frey filament (256 mN). Increased sensory perception will be considered to reflect gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).
Measured: 3 minutes
Dynamic Mechanical Allodynia
Patients will be touched on the affected area and the control area with a brush, an ear stick and a piece of cotton wool. The assessment tools will be applied 4 times by drawing a cross of 2 strokes (length 5 cm) at an angle of 90˚C in each direction. For each stimulus (brush/ear swab/cotton swab), they will indicate (1) whether the stimulus was perceived as painful (yes/no) and (2) the pain intensity on the NRS-11 (0 no pain, 10 imaginably worse pain).
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start27 Oct 2026 (estimated)
- Primary completion27 Oct 2027 (estimated)
- Study completion27 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 SyndromeStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After determining the dominant pain phenotype in patients with CTS, one group will consist of patients with homogeneous neuropathic pain phenotype (Group 1). The heterogeneous group will consist of patients with neuropathic and mixed pain phenotype (both neuropathic and nosiplastic pain phenotype) (Group 2).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Afsar, Kutahya Health Sciences University
- Investigators
- Emrah Afsar, Phd, Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754708
- Sponsor's protocol ID
- Treatment Response in CTS
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carpal Tunnel Syndrome Phenotyping on Response to Treatment
- ClinicalTrials.gov ID
- NCT07754708
- Acronym / sponsor ID
- Treatment Response in CTS
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 27 Oct 2026 (estimated)
- Primary completion
- 27 Oct 2027 (estimated)
- Study completion
- 27 Dec 2027 (estimated)
- First posted
- 10 Aug 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 was to evaluate the effect of Carpal Tunnel Syndrome (CTS) phenotyping on responsiveness to clinical interventions in individuals with CTS.
Detailed description
People between the ages of 18-65, diagnosed with Carpal Tunnel Syndrome, who are suitable for the Neuropathic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System for Carpal Tunnel Syndrome as defined by the International Association for the Study of Pain (IASP) will be applied to patients with CTS. After determining the dominant pain phenotype in patients with CTS, one group will consist of patients with homogeneous neuropathic pain phenotype (Group 1). The heterogeneous group will consist of patients with neuropathic and mixed pain phenotype (both neuropathic and nociplastic pain phenotype) (Group 2). Training, exercise, and wrist splinting will be applied to both groups. The training will include a presentation and booklet on the pathophysiology of CTS, treatment options (conservative treatment and surgery), posture and activity modification principles. Participants will be given a programme of median nerve sliding and tendon sliding exercises as home exercises. The numerical rating scale (NRS) scale will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale, Boston Carpal Tunnel Questionnaire - Functional Status Scale, Michigan Hand Results Questionnaire (MHQ) will be used. Normality of data distribution will be assessed using the Shapiro-Wilk test. Fisher's exact test and chi-square test will be used to verify the relationship between categorical variables. A mixed model ANOVA will be performed on 2 (group 1 and group 2) x 3 (time: baseline, week 6 and week 12) different outcome measures (pain intensity, symptom severity, functional status, Michigan Hand Results Questionnaire (MHQ)) to detect between-group differences.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- After determining the dominant pain phenotype in patients with CTS, one group will consist of patients with homogeneous neuropathic pain phenotype (Group 1). The heterogeneous group will consist of patients with neuropathic and mixed pain phenotype (both neuropathic and nosiplastic pain phenotype) (Group 2).
| Arm | Type | Receives |
|---|---|---|
| Homogeneous Neuropathic Phenotype | Experimental | Other: Standard Rehabilitation ProtocolParticipants assigned to this arm present with a clinically determined, homogeneous neuropathic phenotype. All individuals in this group will receive a standard rehabilitation protocol consisting of patient education, splint application, and a structured exercise program. |
| Heterogeneous Unclassified Phenotype | Active comparator | Other: Standard Rehabilitation ProtocolParticipants assigned to this arm do not have a specifically classified neuropathic phenotype and present with heterogeneous characteristics. All individuals in this group will receive the same standard rehabilitation protocol consisting of patient education, splint application, and a structured exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with CTS
- Being suitable for the neuropathic pain phenotype
- Being between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (7 listed)
- Having systemic inflammatory disease
- Having a disease that may cause polyneuropathy such as diabetes mellitus
- Having a pacemaker
- Having a disease affecting the central nervous system
- Having cervical radiculopathy
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 |
|---|---|---|
| Standard Rehabilitation ProtocolA comprehensive standard rehabilitation program consisting of patient education, application of a clinical splint, and a structured exercise. | Other | Heterogeneous Unclassified Phenotype, Homogeneous Neuropathic Phenotype |
Primary outcome
Numerical Rating Scale
Time frame: Baseline, 6 weeks, 12 weeks
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale
Time frame: Baseline, 6 weeks, 12 weeks
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale is an 11-item questionnaire used to assess symptom severity in individuals with CTS. Each item is scored from 1 to 5. Scores range from 1 (no symptoms) to 5 (worst symptoms). The patient's symptom severity score is the average score of 11 items.
Boston Carpal Tunnel Questionnaire - Functional Status Scale
Time frame: Baseline, 6 weeks, 12 weeks
Boston Carpal Tunnel Questionnaire - Functional Status Scale is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.
Michigan Hand Questionnaire (MHQ)
Time frame: Baseline, 6 weeks, 12 weeks
The Michigan Hand Questionnaire (MHQ) is a hand-specific questionnaire that measures the health status of patients with acute and chronic hand disorders. The MHQ is an outcome tool consisting of 37 questions and 6 domains: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with function. Each domain is scored using an unweighted method by summing the responses on each scale (1 to 5) and normalising the scores to a scale from 0 to 100. A lower score indicates more severe disability, other than pain. The final score is obtained by averaging the six scores after inverting the pain score.
5 secondary outcomes
Cold Pain Threshold
Time frame: 2 minutes
Hot Pain Threshold
Time frame: 2 minutes
Pressure Pain Threshold
Time frame: 3 minutes
Mechanical Pain Threshold
Time frame: 3 minutes
Dynamic Mechanical Allodynia
Time frame: 3 minutes
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 10 Aug 2026.
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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.
Emrah Afsar, Phd principal investigator
Kutahya Health Science University
Questions about this trial
What is this clinical trial studying?
A study testing Standard Rehabilitation Protocol in people with Carpal Tunnel Syndrome, run by Kutahya Health Sciences 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 4 inclusion and 7 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 10 Aug 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 Emrah Afsar, Phd (5062527008, emrah.afsar@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: Baseline, 6 weeks, 12 weeks). 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 10 Aug 2026.