Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain

Study Overview
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Brief Summary
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To assess the effectiveness of a combined physical and psychological intervention in reducing pain and improving function in carpal tunnel syndrome patients with nociplastic pain.

Official Title
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Evaluating the Effectiveness of a Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain: A Randomized Controlled Trial

Conditions
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Carpal Tunnel Syndrome, Pain, Chronic

Intervention / Treatment
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* Other: Combined physical and psychological intervention
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 25-65 years Both sexes Diagnosis of carpal tunnel syndrome based on clinical examination and nerve conduction studies Presence of nociplastic pain as determined by the Central Sensitization Inventory (CSI) with a score ≥40 Positive tinel and phalen sign. Exclusion Criteria: Previous carpal tunnel release surgery Other musculoskeletal or neurological disorders affecting the upper extremity

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive a twelve-week combined physical and psychological intervention. | Other: Combined physical and psychological intervention<br>* Physical therapy components will include splinting, tendon and nerve gliding exercises. Psychological components will include cognitive-behavioral therapy (CBT), delivered in individual sessions, targeting pain catastrophizing and fear of movement. Participants will attend 2 physical therapy sessions and one CBT session per week. for a period of 12 weeks<br>|
| Active Comparator: Control group<br>Participants will receive a twelve-week of standard care of splinting, tendon and nerve gliding exercises. | Other: Standard care<br>* Participants will be asked to wear a prefabricated wrist splint during the night and during strenuous activity. Also, they will receive tendon and nerve gliding exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity using the Numeric Pain Rating Scale (NPRS) |  | Changes in pain intensity at baseline, 6 weeks, 12 weeks. | 
| Functional ability using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire |  | Changes in Functional ability at baseline, 6 weeks, 12 weeks. | 
| Median nerve motor distal latency |  | Changes in Median nerve motor distal latency at baseline, 6 weeks, 12 weeks. | 
| Median nerve sensory distal latency |  | Changes in Median nerve sensory distal latency at baseline, 6 weeks, 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain catastrophizing using the Pain Catastrophizing Scale (PCS) |  | Changes in Pain Catastrophizing Scale (PCS) at baseline, 6 weeks, 12 weeks. | 
| Fear of movement using the Tampa Scale for Kinesiophobia (TSK) |  | Changes in Tampa Scale for Kinesiophobia (TSK) at baseline, 6 weeks, 12 weeks. | 
| Grip strength measured using a hand dynamometer |  | Changes in Grip strength at baseline, 6 weeks, 12 weeks. |