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

NCT ID: NCT05915611

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-27

Study Completion Date

2024-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Combined physical and psychological intervention

Intervention Type 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

Control group

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

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal Fawzy, Ph.d

Role: STUDY_DIRECTOR

Faculty of Physical Therapy, Ahram Canadian University

Locations

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Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed M ElMeligie, Ph.d

Role: CONTACT

+201064442032

Amal Fawzy, Ph.d

Role: CONTACT

+201159880001

Facility Contacts

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Mohamed M ElMeligie, Ph.d

Role: primary

01064442032

Other Identifiers

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012/CTS/120002023

Identifier Type: -

Identifier Source: org_study_id

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