An interventional study of Standard Rehabilitation Protocol in Carpal Tunnel Syndrome, sponsored by Kutahya Health Sciences University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Other
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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.
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 444 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Kutahya Health Sciences University is the lead sponsor of 219 studies on the registry; 48 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Standard Rehabilitation Protocol
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.
Other: Standard Rehabilitation Protocol
A comprehensive standard rehabilitation program consisting of patient education, application of a clinical splint, and a structured exercise.
Numerical Rating Scale
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks, 12 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 3 minutes
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 12 months is close to that.
Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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