NCT06905769

Brief Summary

Carpal Tunnel Syndrome (CTS) is a common neurological disorder due to entrapment of median nerve which runs from the forearm into the hand through a tunnel, compressed or pinched due to anatomical factors, such as a narrow carpal tunnel. Widespread condition that affects 3-6% of the general population worldwide. Carpal Tunnel Syndrome (CTS) a prevalent and debilitating condition leading to disability despite optimal interventions to rehabilitation that aimed to reducing pain and improving neural function status in Carpal Tunnel Syndrome Patients .

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

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 Start

First participant enrolled

March 20, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 25, 2025

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • NUMERIC PAIN RATING SCALE (NPRS)

    The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable". The NPRS is a valid and reliable scale to measure pain intensity. NPRS demonstrates strong correlation validity with other established pain measurement scales, making it a reliable tool for clinical assessments.

    12 Months

  • Boston Carpal Tunnel Questionnaire (BCTQ)

    The questionnaire has been designed to evaluate Assess the severity of CTS symptoms and functional impairment. The total number of questions is 19, total score is 95(sum of 2 subscales) in the BCTQ. Symptom Severity Scale (SSS): 11 items assessing the severity of CTS symptoms, such as numbness, tingling, and pain. Functional Status Scale (FSS) 8 items evaluating the impact of CTS on daily activities, such as grasping, gripping, an carrying. Symptom Severity Scale (SSS): Scores range from 1-5, with higher scores indicating more severe symptoms Functional Status Scale (FSS): Scores range from 1-5, with higher scores indicating greater functional impairment .Reliability 0.95% and Validity 0.80%. Interpretation Symptom Severity Scale (SSS) Mild symptoms: 1-2 Moderate symptoms: 2-3 Severe symptoms: 3-4 Very severe symptoms: 4-5

    12 Months

  • Grip Strength

    Digital Hand Dynamometer is a device used to measure grip strength, which is the force exerted by the hand when grasping an object. Hand Dynamometer units of measurement typically represents the maximum grip strength measured in units Kilograms (kg),Pounds (lb) And Newtons (N). Standard-range dynamometers: 0-100 kg (0-220 lb). Normal Values for Grip Strength Adult Men: 35-55 kg Adult Women: 20-35 kg Interpretation Mild Weakness: 10-20% below normal range. Moderate Weakness: 20-40% below normal range. Severe Weakness: 40-60% below normal range. Profound Weakness: More than 60% below normal range."

    12 Months

Study Arms (2)

Aquatic Therapy

EXPERIMENTAL
Combination Product: Aquatic Therapy

Neuro-Dynamic Technique

EXPERIMENTAL
Diagnostic Test: Neuro-Dynamic Technique

Interventions

Aquatic TherapyCOMBINATION_PRODUCT

Group A was treated with Aquatic Therapy for 30-45 minutes for 3 sessions per week for 8 weeks . Patient should Seated .Therapist will standing or seated beside the patient Therapist Perform gentle stretching on wrist, hand, and finger joints. Exercises to improve range of motion and reduce stiffness. Then perform aquatic therapy for 10 minutes. Therapist instruct patients hands in bath tube. Water temperature 88°F - 94°F (31°C - 34°C).Water depth is Waist-deep or deeper depending on patient comfort

Aquatic Therapy

Group B (Neuro-Dynamic Technique) Group B was treated with Neuro-Dynamic Technique for 15 minutes 3 sessions per week for 8 weeks. Patient should Seated or supine with the affected hand relaxed. Therapist will standing or seated beside the patient. Techniques Time duration is 3 minutes for each technique. wrist distraction 3 sets for 3 minute rhythmic and gentle stretching of the transverse carpel ligament Release of palmar fascia gliding of finger flexor tendons release of upper forearm muscle and fascia.

Neuro-Dynamic Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with mild-to-moderate carpal tunnel syndrome by Neuromuscular Physician
  • Participants who presented with unilateral CTS with symptoms reported up to 3 months
  • Male and female
  • Aged 18 years or older

You may not qualify if:

  • Patients with non-specified stage of CTS,median nerve entrapment in TOS, Cervical Radiculpathy
  • Participants presents with co-morbidities,Hx of CTS (e.g., pregnancy, diabetes, trauma, congenital disorders, obesity, post-surgical release, and hypothyroidism)
  • Cardiovascular disease, thenar muscle atropy"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior University CRC

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations