Effects of Kinesiotaping With and Without Active Release Technique in Patients With Carpal Tunnel Syndrome

April 26, 2022 updated by: Riphah International University

Effects of Kinesiotaping With and Without Active Release Technique on Pain, Grip Strength, Functional Disability and Range of Motion in Patients With Carpal Tunnel Syndrome

The goal of this study is to compare the effects of Kinesiotaping and Active Release Technique in patients with CTS to see which method is better for improving Pain, Grip Strength, Range of Motion and functional disability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Carpal tunnel syndrome (CTS) is a common nerve entrapment condition that causes pain, numbness, tingling and weakness in the hand and wrist. People suffering from CTS complain of pain, decreased ROM, loss of grip strength and in severe cases, disability. This happens when there is an increased pressure within the wrist on a nerve called "Median Nerve". This nerve provides sensations to the thumb, index, middle and half of the ring finger. People who are most susceptible to CTS are computer/keyboard workers. High force, extreme wrist motions, vibrations are causes. Other factors like genetics and pregnancy can also cause CTS. There are a lot of treatment options for CTS such as use of orthotics, steroidal injections, surgery and physical therapy. The aim of this study will be to determine the effects of kinesiotaping with and without active release technique on pain, grip strength, functional disability and range of motion in patients with carpal tunnel syndrome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 38000
        • Recruiting
        • Ittefaq Hospital
        • Principal Investigator:
          • Janisar Zainab, MS-OMPT

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having symptoms for less than 1 year.

    • Age above 18 years.
    • Patients having positive Tinel and Phalen test.
    • Pain in the median nerve distribution with minimum score of 3 on NPRS. Ability to read and understand the study instructions and written consent form

Exclusion Criteria:

  • Having any secondary entrapment neuropathy like diabetes, inflammatory arthritis, and hypothyroidism.

    • Pregnancy Skin infection on the forearm, cervical radiculopathy or polyneuropathy.
    • Previous history of Carpal Tunnel Decompression Surgery.
    • Corticosteroid injection into the Carpal Tunnel.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kinesiotaping
Kinesiotape will be applied toward the start of the week, to remain on for 5 days with a multi day rest for an aggregate of about a month.
Other: Kinesiotape
Tape with a width of 5 cm and a thickness of 0.5 mm will be utilized. Kinesio Tex I Strip is estimated from elbow to fingertips and cut. It will be collapsed roughly two squares from the end and cut into two triangles on the overlay. The third and fourth fingers are fallen through openings and Kinesio Tex is applied on the dorsum of the hand with no strain. The situation of elbow extension, wrist extension, and radial deviation is given, and Kinesio Tex will be applied from hand to medial epicondyle with 15%-25% tension and end at medial epicondyle with no strain
Experimental: Active Release Technique
kinesiotaping and active release technique will be applied 3 times a week for 2 week
Other: Active Release Technique
This group will receive Kinesiotaping with the same method along with Active release technique will be performed on group 2. We will apply profound tension at the region of tenderness while the patient is told to effectively move the injury site from a shortened to lengthened position. The setting of a contact point close to the injury and making the patient move in a way that creates a longitudinal sliding movement of delicate tissues e.g. nerves, ligaments and muscles underneath the contact point.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NPRS
Time Frame: 3 months
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
3 months
hand dynamometer
Time Frame: 3 months
A hand dynamometer is an evaluation tool that's used to measure isometric grip force (hand grip strength). Some versions use hydraulics to measure the force while others use electronic load cells. Once the grip position is adjusted, the user holds the handle and squeezes the handle
3 months
Boston CTS Questionnaire
Time Frame: 3 months
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of selfreported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome
3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nosheen Manzoor, MS, Riphah International University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/Lhr/22/0111 Janisar

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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