NCT07539480

Brief Summary

Carpal Tunnel Syndrome (CTS) is one of the most common compressive neuropathies of the upper limb, characterized by pain, numbness, and functional impairment due to median nerve compression at the wrist. Its prevalence is estimated at approximately 4.9%, with higher incidence in populations exposed to repetitive hand movements. The resulting sensory disturbances, grip weakness, and functional limitations significantly affect daily activities and quality of life. Conservative management remains the first line of treatment for mild to moderate CTS, with therapeutic approaches traditionally including splinting, exercise therapy, nerve mobilization, and patient education. Recent interest has grown around Pain Neuroscience Education (PNE)-an educational strategy that reframes patients' understanding of pain by emphasizing the role of the central nervous system, cognitive factors, and neurophysiological processes. Studies have shown that PNE, particularly when combined with exercise or standard rehabilitation, can reduce symptom severity, improve functional outcomes, and help patients better manage chronic pain by reducing fear and catastrophizing. However, the existing literature notes that research on PNE for CTS is still limited, with some trials suggesting positive outcomes but calling for more high-quality evidence. In parallel, Kinesio Taping (KT) has gained popularity as a noninvasive intervention believed to enhance circulation, provide proprioceptive input, and support soft tissue mobility. Evidence from randomized controlled trials shows that KT can improve grip strength, reduce pain intensity, enhance sensory conduction velocity, and improve functional status as measured by validated clinical tools such as the Boston Carpal Tunnel Questionnaire. These findings suggest that KT may serve as an effective supplementary therapy in the conservative management of CTS

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Jun 2025Sep 2027

Study Start

First participant enrolled

June 15, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Kinesio tapecarpal tunnel syndrome

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    self-reported pain intensity scale ranging from 0 (no pain) to 10 (worst imaginable pain), assessing average hand pain over the past week.

    8 weeks

  • Boston Carpal Tunnel Questionnaire

    The BCTQ is a tool that assesses difficulty in performing daily activities of the hand such as writing, gripping and lifting objects It consists of eight items, each scored from 1 (no difficulty) to 5 (unable to perform activity). Higher scores indicate greater functional disability.

    8 months

  • Jamar Hand-Held Dynamometer (kg)

    Assess the maximum voluntary grip strength of the affected hand. Three trials are recorded, and the mean value is used for analysis.

    8 months

Study Arms (2)

group A: pain neuroscience education (PNE)

EXPERIMENTAL

PNE Components

Other: group A: pain neuroscience education (PNE)

group B: Patients receive Kinesio Taping

EXPERIMENTAL

KT Application Technique

Other: group B: Patients receive Kinesio Taping

Interventions

1- Education on neurobiology and neurophysiology of pain 2- How beliefs and behaviours influence pain 3- Central sensitization and pain amplification 4- Use of metaphors, visuals, and interactive discussion the frequency of the session 1- 1 session/week, 30-40 minutes 2- Duration: 6 weeks 3- Delivered by a trained physiotherapist

group A: pain neuroscience education (PNE)

KT Application Technique 1- Elastic tape placed along flexor retinaculum and median nerve pathway 2- Tension: 10-15% 3- Reapplied twice weekly 4- Duration: 6 weeks

group B: Patients receive Kinesio Taping

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18 to 60 years.
  • Clinically diagnosed unilateral or bilateral carpal tunnel syndrome based on standard diagnostic criteria (e.g., pain, numbness, or tingling in the median nerve distribution), with or without confirmation by nerve conduction studies.
  • Patients with mild to moderate carpal tunnel syndrome, defined by clinical assessment and electrodiagnostic findings.
  • Symptoms present for at least 3 months.
  • Reported wrist or hand pain with functional limitations affecting daily activities.

You may not qualify if:

  • Severe CTS characterised by significant thenar muscle atrophy or severe nerve conduction impairment.
  • Previous Surgery or Injection:
  • History of carpal tunnel release surgery or corticosteroid injection to the wrist within the past 6 months.
  • Presence of other conditions affecting the upper limb, such as cervical radiculopathy, peripheral neuropathy, rheumatoid arthritis, tendon rupture, or fractures.
  • Known neurological disorders (e.g., stroke, multiple sclerosis) or systemic diseases affecting nerve function (e.g., uncontrolled diabetes mellitus).
  • Skin disease, open wounds, or known allergy to adhesive materials that contraindicate kinesio taping.
  • Pregnant women, due to possible changes in fluid retention and nerve compression.
  • Participation in other physical therapy or pain education programmes targeting the upper limbs during the study period.
  • Conditions that limit comprehension of pain neuroscience education material or ability to provide reliable responses to questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassam Ahmed Nabil

October City, Giza Governorate, 6892, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

June 15, 2025

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

September 20, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations