Comparative Effects of Sensory Re-education and Neural Mobilization in CTS Patients

November 12, 2024 updated by: Riphah International University

Comparative Effects of Sensory Re-education and Neural Mobilization in Carpal Tunnel Syndrome Patients

The aim of study is to compare the effects of sensory re-education and neural mobilization in CTS patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be randomized clinical trial that will be conducted at Services Hospital Lahore and Government Teaching Hospital Shahdara. In this study 48 participants with CTS will be included as per sample size calculation through non-probability convenience sampling technique. Participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Sensory Re-education therapy, strengthening exercises and Kinesio taping for 60 minutes, Group B will be given neural mobilization techniques, strengthening exercises and Kinesio taping for 60 minutes with short rest intervals. Both treatments will be given 3 days per week for 12 weeks.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both genders age 20-50 years with mild and moderate carpal tunnel syndrome.
  • Patients having positive score on CTS specific test (Phalen's test and Tinel's test).
  • Patients with pain, paresthesia and hyperesthesia at the course of median nerve.
  • Patients that are clinically diagnosed with carpal tunnel syndrome by physician. Patients having BMI >25 (kg/m2).

Exclusion Criteria:

  • Patients with polyneuropathies.
  • Patients with carpal tunnel syndrome due to any systemic illness (diabetes mellitus, thyroid diseases and R.A).

Patients having cervical radiculopathy.

Patients with history of wrist fracture.

Patients getting steroid injections and after CTS surgery.

Obese and pregnant female with carpal tunnel syndrome.

Patients with any cognitive or neurological problems are excluded from study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Sensory re-education program, strengthening exercises and kinesio taping

The patient will be given a session of 60 minutes 3 days in a week which includes : Splinting (15 minutes), Topical anesthesia spray (10 minutes ) and wrist massage (10 minutes).

  • PNF using upper extremity (D2) pattern (5 minutes).
  • Strengthening exercises (20 minutes) and Kinesio taping for 12 weeks.
Other: Sensory re-education+ strengthening exercises+ kinesio taping

Sensory re-education. Splinting: as constant maintained touch with wrist holding in neutral position for 15 minutes.

Topical anesthesia spray on affected area for 10 minutes. Massage: apply massage over sensitive areas with same speed and pressure, then the light pressure with cotton, velvet, terry cloth, polyester and wool over sensitive area for 10 minutes.

PNF using upper extremity (D2) pattern including shoulder extension, adduction, internal rotation, wrist and fingers flexed and wrist ulnar deviated. 10-15 repetitions for 5 minutes.

Strengthening exercises: wrist flexion and extension, supination and pronation, opposition, gripping, ball squeeze and fingers pinching against resistance. 10-15 repetitions of each exercise for 20 minutes.

Kinesio taping: Taping will be applied twice a week for 12 weeks.
Experimental: Group B:Neural mobilization of median nerve, strengthening exercises and kinesio taping.

The patient will be given a session of 60 minutes 3 days in a week which includes: ,Median nerve mobilization through various steps of gliding. (30 minutes).

  • Free the bird exercise. (10 minutes).
  • Strengthening exercises (20 minutes) and kinesio taping for 12 weeks.
Other: Neural mobilization+ Strengthening exercises+ Kinesio taping.

The median nerve is mobilized through wrist flexion and extension with elbow straight and palm facing up.

Wrist flexion and extension with elbow flexed to 90 degrees with palm facing up 10-15 repetitions.

Wrist flexors stretch with extended arm and palm facing down 10-15 repetitions. Straight fist: hold your hand up with fingers straight. Full fist: bend your fingers to form a full fist. Median nerve stretch and wrist extension exercises for 30 minutes. Free the bird exercises, busy bee flexion shape of Z exercises and wall stretch exercise. (10-15 repetitions) for 10 minutes.

Strengthening exercises: wrist flexion and extension, supination and pronation, opposition, gripping, ball squeeze and fingers pinching against resistance. 10-15 repetitions each for 20 minutes.

Kinesio taping: The taping will be applied twice a week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical pain rating scale
Time Frame: 12th week
The NPRS is use to capture the patient's level of pain. Patients are allowed to indicate the intensity of their current pain level using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).
12th week
Boston Carpal Tunnel Questionnaire
Time Frame: 12th week
A patient self-reported questionnaire includes 2 sub scales: The Symptom Severity Scale (SSS), which comprise 11 questions and uses a 5- point Likert scale; and the Functional Status Scale (FSS) having 8 items, which have to be evaluated for degree of difficulty on a 5-point Likert scale. Each scale generates a final score (sum of scores divided by number of items), which ranges from 1 to 5, with a higher score predicting greater disability.
12th week
Hand Held Dynamometer
Time Frame: 12th week
Hand grip strength is measured using a handheld dynamometer. Patients are asked to grip the dynamometer isometrically and advised to grip it as hard as they can. Readings will be taken in pounds lb. The average value of 3 trials is recorded.
12th week
Pinch gauge meter
Time Frame: 12th week
Tip pinch grip strength will be assessed using a manual dynamometer (pinch gauge meter). Participants asked to perform a maximal pinch grip by pressing the gauge between the tip of their thumb and index finger. The average of three trials will calculated and defined as the maximal tip pinch grip strength measured in kilograms.
12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Chair: Muhammad Kashif, Phd, Riphah International University Lahore Punjab, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/24/0233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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