Carpal Tunnel SyndromeNCT06635213
Effectiveness of Desensitisation and Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain
A study testing Desensitisation and Pain neuroscience education in people with Carpal Tunnel Syndrome, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic). 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?
- Desensitisation and Pain neuroscience education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 10 Jun 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 nosiplastic 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Science University
Kütahya
Emrah Afsar, Phd, 5062527008, emrah.afsar@ksbu.edu.tr
Emrah Afsar, Phd
About this study
Official title: Determination of the Effectiveness of Desensitisation and Pain Neuroscience Training in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain Phenotype
The aim of our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic).
Read the detailed description
People between the ages of 18-65, diagnosed with Carpal Tunnel Sedrome, who are suitable for the Nosiplastic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain will be applied to patients with CTS. After determining the predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education. Numerical rating scale (NRS) will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale will be used for symptom severity assessment and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used for functional status assessment. Pressure pain threshold will be measured with an algometer to evaluate hypersensitivity. The Pain Catastrophising Scale and the Tampa Kinesiophobia Scale will be administered to the patients. Normality of the data distribution will be assessed using the Shapiro-Wilk test. Fischer'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, post-intervention, 3 months post-intervention) different outcome measures (pain intensity, symptom severity, functional status, pain catastrophising and kinesiophobia) to detect between-group differences.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Desensitisation, Pain neuroscience education
- 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.
DesensitisationOther
This technique is utilized to decrease, or normalize, the body's response to particular sensations.
Pain neuroscience educationOther
PNE is an educational intervention aiming to alter a patient's beliefs and cognitions regarding their pain experience.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (desensitisation) | Active comparator | Group 1 will receive desensitisation. Receives: Other: Desensitisation |
| Group 2 (desensitisation and pain neuroscience education) | Active comparator | Group 2 will receive desensitisation and pain neuroscience education. Receives: Other: Desensitisation; Other: Pain neuroscience education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Paın Threshold Measurement
The pressure pain threshold (PPT), the minimum amount of pressure at which the pressure sensation changes to pain, is measured with an electronic algometer (median nerve, ulnar nerve and radial nerve, C5-C6 zygapophyseal joint level (proximal), and tibialis anterior). Participants are asked to report when the sensation changes from pressure to pain. The mean of the three trials is calculated (with a 30 s rest interval in between).
Measured: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
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: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
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: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Pain Catastrophising Scale
The Catastrophising Pain Scale (PCS) is used to measure catastrophising in response to pain through 13 statements with four possible options from 1 "never" to 4 "always". Higher scores indicate greater catastrophised pain.
Measured: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Tampa Kinesiophobia Scale
It is a 17-question scale. The scale has a 4-point Likert scale (1= Strongly disagree, 4= Strongly agree). After reversing items 4, 8, 12 and 16, a total score is calculated. The person receives a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Measured: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Numerical Rating Scale
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
Measured: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
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 3 cm2 sized 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 Oct 2024
- Study start25 Oct 2024
- Primary completion25 Apr 2027 (estimated)
- Study completion10 Jun 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 predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635213
- Sponsor's protocol ID
- 2024-b
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2024
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effectiveness of Desensitisation and Pain Neuroscience Training in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain Phenotype
- ClinicalTrials.gov ID
- NCT06635213
- Acronym / sponsor ID
- 2024-b
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 10 Oct 2024 (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 our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic).
Detailed description
People between the ages of 18-65, diagnosed with Carpal Tunnel Sedrome, who are suitable for the Nosiplastic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain will be applied to patients with CTS. After determining the predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education. Numerical rating scale (NRS) will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale will be used for symptom severity assessment and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used for functional status assessment. Pressure pain threshold will be measured with an algometer to evaluate hypersensitivity. The Pain Catastrophising Scale and the Tampa Kinesiophobia Scale will be administered to the patients. Normality of the data distribution will be assessed using the Shapiro-Wilk test. Fischer'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, post-intervention, 3 months post-intervention) different outcome measures (pain intensity, symptom severity, functional status, pain catastrophising and kinesiophobia) to detect between-group differences.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After determining the predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (desensitisation) | Active comparator | Other: DesensitisationGroup 1 will receive desensitisation. |
| Group 2 (desensitisation and pain neuroscience education) | Active comparator | Other: Desensitisation, Other: Pain neuroscience educationGroup 2 will receive desensitisation and pain neuroscience education. |
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 nosiplastic 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 |
|---|---|---|
| DesensitisationThis technique is utilized to decrease, or normalize, the body's response to particular sensations. | Other | Group 1 (desensitisation), Group 2 (desensitisation and pain neuroscience education) |
| Pain neuroscience educationPNE is an educational intervention aiming to alter a patient's beliefs and cognitions regarding their pain experience. | Other | Group 2 (desensitisation and pain neuroscience education) |
Primary outcome
Pressure Paın Threshold Measurement
Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
The pressure pain threshold (PPT), the minimum amount of pressure at which the pressure sensation changes to pain, is measured with an electronic algometer (median nerve, ulnar nerve and radial nerve, C5-C6 zygapophyseal joint level (proximal), and tibialis anterior). Participants are asked to report when the sensation changes from pressure to pain. The mean of the three trials is calculated (with a 30 s rest interval in between).
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale
Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
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: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
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.
Pain Catastrophising Scale
Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
The Catastrophising Pain Scale (PCS) is used to measure catastrophising in response to pain through 13 statements with four possible options from 1 "never" to 4 "always". Higher scores indicate greater catastrophised pain.
Tampa Kinesiophobia Scale
Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
It is a 17-question scale. The scale has a 4-point Likert scale (1= Strongly disagree, 4= Strongly agree). After reversing items 4, 8, 12 and 16, a total score is calculated. The person receives a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Numerical Rating Scale
Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
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 12 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desensitisation and Pain neuroscience education in people with Carpal Tunnel Syndrome, run by Kutahya Health Sciences 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 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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?
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?
Pressure Paın Threshold Measurement (time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]). The study lists 6 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 12 Aug 2025.