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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05915611
Enrollment
64
Registered
2023-06-23
Start date
2023-06-27
Completion date
2024-09-27
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Pain, Chronic

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.

Interventions

OTHERCombined 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

OTHERStandard 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

Sponsors

Ahram Canadian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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) questionnaireChanges in Functional ability at baseline, 6 weeks, 12 weeks.
Median nerve motor distal latencyChanges in Median nerve motor distal latency at baseline, 6 weeks, 12 weeks.
Median nerve sensory distal latencyChanges in Median nerve sensory distal latency at baseline, 6 weeks, 12 weeks.

Secondary

MeasureTime frame
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 dynamometerChanges in Grip strength at baseline, 6 weeks, 12 weeks.
Pain catastrophizing using the Pain Catastrophizing Scale (PCS)Changes in Pain Catastrophizing Scale (PCS) at baseline, 6 weeks, 12 weeks.

Countries

Egypt

Contacts

Primary ContactMohamed M ElMeligie, Ph.d
mohamed.elmeligie@acu.edu.eg+201064442032
Backup ContactAmal Fawzy, Ph.d
dr.amalfawzy@acu.edu.eg+201159880001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026