NCT05788471

Brief Summary

The purpose of this study is to examine:

  1. 1.The effect of neurodynamic mobilization on the sensory and motor median nerve conduction velocity in carpal tunnel syndrome.
  2. 2.The effect of neurodynamic mobilization on the wrist pain in carpal tunnel syndrome.
  3. 3.The effect of neurodynamic mobilization on the hand function in carpal tunnel syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 15, 2023

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessing the change in nerve conduction velocity of the median nerve.

    By using Electromyography apparatus measuring nerve conduction velocity of the median nerve. (motor and sensory in m/s)

    at baseline and after 4 weeks of intervention

  • Assessing the change in wrist joint pain

    By using Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. A simple handheld pressure algometer (PA) with a spring is commonly used, although more sophisticated electrical devices with a strain or pneumatic pressure gauge have been developed. They hold the peak force or pressure (kp (kilopond) = 10 N, Newton = 100 kPa (kilopascal)) until tared, and some may also be connected to a computer and thus have continuous output. PPT measured with a probe 1.6 mm in diameter or larger reflects the tenderness of deep tissues as anesthesia of skin only affects the results of smaller probes.

    at baseline and after 4 weeks of intervention

  • Assessing the change in functional activity of the hand

    By using Modified DASH questionnaire will be used for functional activity of the hand. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.

    at baseline and after 4 weeks of intervention

Study Arms (2)

Conventional treatment group

ACTIVE COMPARATOR

Twenty patients will receive conventional treatment in the form of superficial heat, ultrasound with freq of 1 MHz, pulsed mode 1:4 for 5 min and stretching exercise to lumbrical muscles of the hand.

Other: conventional Treatment

Neurodynamic mobilization therapy group

EXPERIMENTAL

Twenty patients will receive neurodynamic mobilization therapy (upper limb tension test 1) in addition to conventional treatment.

Other: conventional TreatmentOther: Neurodynamic mobilization

Interventions

It consists of Superficial heat, Ultrasound therapy and stretching exercise to lumbrical muscles of the hand.

Conventional treatment groupNeurodynamic mobilization therapy group

It is the mobilisation of the nervous system as an approach to physical treatment of pain. The treatment and or assessment relies on influencing pain physiology via the mechanical treatment of neural tissues and non-neural structures surrounding the nervous system.

Neurodynamic mobilization therapy group

Eligibility Criteria

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

You may qualify if:

  • Forty carpal tunnel syndrome patients.
  • All participants referred from a physician.
  • Their ages range from 20-50 years old.
  • Both genders will participate in the study.
  • Their BMI ranges between 18.5-24.9kg/m2.
  • All participants have carpal tunnel syndrome at least in one hand.
  • All participants suffering from mild to moderate carpal tunnel syndrome.

You may not qualify if:

  • Previous or current disease or trauma that might affect one or both upper limbs.
  • Metabolic diseases that might associated with entrapment neuropathy such as diabetes mellitus, thyroid diseases, and autoimmune diseases.
  • Pregnant women.
  • Participants with congenital hand deformities.
  • History of hand surgery.
  • Sever cases of carpal tunnel syndrome that suffering from weakness of hand grip and atrophy of thenar muscle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic faculty of physica therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

Median NeuropathyCarpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Raghda Ahmed

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
Principal Investigator

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 29, 2023

Study Start

April 1, 2023

Primary Completion

June 15, 2023

Study Completion

August 15, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations