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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915611
• Other study ID #: 012/CTS/120002023
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: September 27, 2024

Study information

• Verified date: June 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Chronic Pain
• Pain, Chronic
• Syndrome

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
• 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

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity using the Numeric Pain Rating Scale (NPRS)		Changes in pain intensity at baseline, 6 weeks, 12 weeks.
Primary	Functional ability using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire		Changes in Functional ability at baseline, 6 weeks, 12 weeks.
Primary	Median nerve motor distal latency		Changes in Median nerve motor distal latency at baseline, 6 weeks, 12 weeks.
Primary	Median nerve sensory distal latency		Changes in Median nerve sensory distal latency at baseline, 6 weeks, 12 weeks.
Secondary	Pain catastrophizing using the Pain Catastrophizing Scale (PCS)		Changes in Pain Catastrophizing Scale (PCS) at baseline, 6 weeks, 12 weeks.
Secondary	Fear of movement using the Tampa Scale for Kinesiophobia (TSK)		Changes in Tampa Scale for Kinesiophobia (TSK) at baseline, 6 weeks, 12 weeks.
Secondary	Grip strength measured using a hand dynamometer		Changes in Grip strength at baseline, 6 weeks, 12 weeks.