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

NCT05915611 | Unknown

• 1 other identifier: 012/CTS/120002023
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Pain, Chronic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive a twelve-week combined physical and psychological intervention.

Other: Combined physical and psychological intervention

Control group

ACTIVE COMPARATOR

Participants will receive a twelve-week of standard care of splinting, tendon and nerve gliding exercises.

Other: Standard care

Interventions

Combined physical and psychological intervention OTHER

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

Intervention group

Standard care OTHER

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

Control group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous carpal tunnel release surgery
• Other musculoskeletal or neurological disorders affecting the upper extremity

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Chronic Pain

Interventions

Psychosocial Intervention; Standard of Care

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Amal Fawzy, Ph.d

CONTACT

+201159880001; dr.amalfawzy@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: June 27, 2023
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)