Back to resultsCombined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain
Primary Purpose
Carpal Tunnel Syndrome, Pain, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Combined physical and psychological intervention
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
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
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Participants will receive a twelve-week combined physical and psychological intervention.
Participants will receive a twelve-week of standard care of splinting, tendon and nerve gliding exercises.
Outcomes
Primary Outcome Measures
Pain intensity using the Numeric Pain Rating Scale (NPRS)
Functional ability using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Median nerve motor distal latency
Median nerve sensory distal latency
Secondary Outcome Measures
Pain catastrophizing using the Pain Catastrophizing Scale (PCS)
Fear of movement using the Tampa Scale for Kinesiophobia (TSK)
Grip strength measured using a hand dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05915611
Brief Title
Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain
Official Title
Evaluating the Effectiveness of a Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Anticipated)
Primary Completion Date
September 27, 2024 (Anticipated)
Study Completion Date
September 27, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will receive a twelve-week combined physical and psychological intervention.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants will receive a twelve-week of standard care of splinting, tendon and nerve gliding exercises.
Intervention Type
Other
Intervention Name(s)
Combined physical and psychological intervention
Intervention Description
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
Intervention Name(s)
Standard care
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity using the Numeric Pain Rating Scale (NPRS)
Time Frame
Changes in pain intensity at baseline, 6 weeks, 12 weeks.
Title
Functional ability using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time Frame
Changes in Functional ability at baseline, 6 weeks, 12 weeks.
Title
Median nerve motor distal latency
Time Frame
Changes in Median nerve motor distal latency at baseline, 6 weeks, 12 weeks.
Title
Median nerve sensory distal latency
Time Frame
Changes in Median nerve sensory distal latency at baseline, 6 weeks, 12 weeks.
Secondary Outcome Measure Information:
Title
Pain catastrophizing using the Pain Catastrophizing Scale (PCS)
Time Frame
Changes in Pain Catastrophizing Scale (PCS) at baseline, 6 weeks, 12 weeks.
Title
Fear of movement using the Tampa Scale for Kinesiophobia (TSK)
Time Frame
Changes in Tampa Scale for Kinesiophobia (TSK) at baseline, 6 weeks, 12 weeks.
Title
Grip strength measured using a hand dynamometer
Time Frame
Changes in Grip strength at baseline, 6 weeks, 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Fawzy, Ph.d
Phone
+201159880001
Email
dr.amalfawzy@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain
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