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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Pain, Chronic
• Intervention / Treatment: Other: Combined physical and psychological intervention; Other: Standard care

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg
• Study Contact Backup: Name: Amal Fawzy, Ph.d; Phone Number: +201159880001; Email: dr.amalfawzy@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 27, 2023
• Primary Completion (Estimated): September 27, 2024
• Study Completion (Estimated): September 27, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Chronic Pain
• Other Study ID Numbers: 012/CTS/120002023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No