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

Sponsor

Ahram Canadian University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05915611

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jun 27, 2023

Anticipated Primary Completion Date :

Sep 27, 2024

Anticipated Study Completion Date :

Sep 27, 2024

Arms and Interventions

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

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

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al Ḩayy Ath Thāmin	Giza	Egypt	3221405

Sponsors and Collaborators

Ahram Canadian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Syndrome

Chronic Pain

Study Results

No Results Posted as of Jun 23, 2023