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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (desensitisation) | Active Comparator | Group 1 will receive desensitisation. |
|
| Group 2 (desensitisation and pain neuroscience education) | Active Comparator | Group 2 will receive desensitisation and pain neuroscience education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desensitisation | Other | This technique is utilized to decrease, or normalize, the body's response to particular sensations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | [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. | [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. | [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. | [at the beginning of the study] [At the end of 6 weeks] [3 months later] |
| Tampa Kinesiophobia Scale |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emrah Afsar, Phd | Contact | 5062527008 | emrah.afsar@ksbu.edu.tr | |
| Ayse Kocak Sezgin, Phd | Contact | +90 5072243706 | ayse.kocaksezgin@ksbu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kutahya Health Science University | Recruiting | Kütahya | Turkey (Türkiye) |
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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.
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| Pain neuroscience education | Other | PNE is an educational intervention aiming to alter a patient's beliefs and cognitions regarding their pain experience. |
|
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. |
| [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"). | [at the beginning of the study] [At the end of 6 weeks] [3 months later] |
| 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). |
| 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). | 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). | 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). | 3 minutes |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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