Non-surgical Intervention for Carpal Tunnel Syndrome

NCT ID: NCT03360344

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2018-10-23

Brief Summary

This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain.

Detailed Description

This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain. Little evidence exists for an effective non-surgical intervention. Semi-structured interviews will be conducted to explore changes in occupational performance and compliance in order to understand if Kinesio Tape contributed to results and if so, how the participants perceived the interventions.

Conditions

Carpal Tunnel Syndrome, Susceptibility to

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Kinesio Tape

Dorsal application of Kinesio Tape to the affected extremity: Approximately 12 inches of Kinesio tape will be applied from the musculotendinous junction of the participant's forearm over digits 1 and 5. Two - 2 inch strips of Kinesio Tape will be applied to the participant's wrists over the volar and dorsal aspects. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application by the researchers four times during the course of the study.

A tape removal form will be provided should the participants want to remove it prior to the next visit.

Group Type: EXPERIMENTAL

Kinesio 12 inch Tape

Intervention Type: DEVICE

Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study.

Control group

Approximately 4 inch strip of Kinesio Tape will be applied to the scapular spine of the same side as the affected extremity. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application four times during the course of the study by the researcher. A tape removal form will be provided should the participants want to remove it prior to the next visit.

Group Type: SHAM_COMPARATOR

Kinesio 4 inch Tape

Intervention Type: DEVICE

Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study.

Standard of Care

Currently, the standard of care is a general cock-up splint and lumbrical exercises. A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.

Group Type: ACTIVE_COMPARATOR

Cock up Splint and Lumbrical exercises

Intervention Type: DEVICE

A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.

Interventions

Kinesio 12 inch Tape

Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study.

Intervention Type: DEVICE

Kinesio 4 inch Tape

Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study.

Intervention Type: DEVICE

Cock up Splint and Lumbrical exercises

A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults > 18 years of age
• Fluent in English
• Report signs and symptoms of carpal tunnel syndrome
• Pain, numbness, and tingling of the forearm, wrist, or hand, which worsen at night
• Demonstrate positive Phalen's Test or Tinel's Test of the affected extremity

Exclusion Criteria

• Currently receiving treatment for carpal tunnel syndrome
• History of surgical carpal tunnel release
• Pregnant
• Diabetes not controlled by medication
• Radiculopathy ie: cervical radiculopathy, diabetic radiculopathy
• Thoracic outlet syndrome
• Allergy to adhesives or compromised skin integrity
• Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Heather Javaherian-Dysinger

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grenith Zimmerman, PhD

Role: STUDY_CHAIR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5170437

Identifier Type: -

Identifier Source: org_study_id