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

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ClinicalTrials.gov Identifier: NCT05915611
Recruitment Status : Recruiting
First Posted : June 23, 2023
Last Update Posted : June 23, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Magdy ElMeligie, Ahram Canadian University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Pain, Chronic Other: Combined physical and psychological intervention Other: Standard care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of a Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain: A Randomized Controlled Trial
Estimated Study Start Date : June 27, 2023
Estimated Primary Completion Date : September 27, 2024
Estimated Study Completion Date : September 27, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Participants will receive a twelve-week combined physical and psychological intervention.
 Other: Combined physical and psychological intervention

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
Active Comparator: Control group
Participants will receive a twelve-week of standard care of splinting, tendon and nerve gliding exercises.
 Other: Standard care
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


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity using the Numeric Pain Rating Scale (NPRS) [ Time Frame: Changes in pain intensity at baseline, 6 weeks, 12 weeks. ]
  2. Functional ability using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: Changes in Functional ability at baseline, 6 weeks, 12 weeks. ]
  3. Median nerve motor distal latency [ Time Frame: Changes in Median nerve motor distal latency at baseline, 6 weeks, 12 weeks. ]
  4. Median nerve sensory distal latency [ Time Frame: Changes in Median nerve sensory distal latency at baseline, 6 weeks, 12 weeks. ]

Secondary Outcome Measures :
  1. Pain catastrophizing using the Pain Catastrophizing Scale (PCS) [ Time Frame: Changes in Pain Catastrophizing Scale (PCS) at baseline, 6 weeks, 12 weeks. ]
  2. Fear of movement using the Tampa Scale for Kinesiophobia (TSK) [ Time Frame: Changes in Tampa Scale for Kinesiophobia (TSK) at baseline, 6 weeks, 12 weeks. ]
  3. Grip strength measured using a hand dynamometer [ Time Frame: Changes in Grip strength at baseline, 6 weeks, 12 weeks. ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05915611


Contacts
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Contact: Mohamed M ElMeligie, Ph.d +201064442032 mohamed.elmeligie@acu.edu.eg
Contact: Amal Fawzy, Ph.d +201159880001 dr.amalfawzy@acu.edu.eg

Locations
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Egypt
Outpatient clinic of faculty of physical therapy, Ahram Canadian University Recruiting
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
Contact: Mohamed M ElMeligie, Ph.d    01064442032    mohamed.elmeligie@acu.edu.eg   
Sponsors and Collaborators
Ahram Canadian University
Investigators
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Study Director: Amal Fawzy, Ph.d Faculty of Physical Therapy, Ahram Canadian University
More Information
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Responsible Party: Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier: NCT05915611    
Other Study ID Numbers: 012/CTS/120002023
First Posted: June 23, 2023    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Chronic Pain
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Pain
Neurologic Manifestations