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Non-surgical Intervention for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome, Susceptibility to

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinesio 12 inch Tape
Kinesio 4 inch Tape
Cock up Splint and Lumbrical exercises
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carpal Tunnel Syndrome, Susceptibility to focused on measuring carpal tunnel syndrome, pain, numbness, kinesio tape

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Kinesio Tape

Control group

Standard of Care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale (NRS Pain)
Numerical Pain Rating Scale (NRS Pain) involves patient circling a number from 0-10 with "0" meaning no pain and "5" moderate pain, and "10" is worst possible pain. The NRS is a segmented numeric scale, which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. Higher scores indicate greater pain intensity.
Visual Analog Scale for Pain (VAS Pain)
The Visual Analogue Scale (VAS) is unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS measures participants perception of pain on a continuous scale. Individuals place a mark on a 10cm-long line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. These are measured every 3 days for 3 weeks from baseline in the forearm, wrist and fingers.

Secondary Outcome Measures

Grip Strength and Pinch Strength
Grip strength is measured by Jamar Dynamometer hydraulic gauge following standard protocol. A Jamar hydraulic pinch meter gauge is used to measure finger strength in the following positions: Lateral pinch, pad to pad, and 3 Jaw-chuck pinch positions are used. Grip and pinch strength will be measured every 3 days for 3 weeks from baseline.
Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS)
The Boston Carpal Tunnel Questionnaire (BCTQ SS) is a standardised, patient-based outcome measure of symptom severity in patients with carpal tunnel syndrome. The questionnaire has 11 questions and uses a five-point rating scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline.
Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS)
The Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) is self report 8-item questionnarie on functional activities for individuals with carpal tunnel, which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline.

Full Information

First Posted
November 28, 2017
Last Updated
September 15, 2020
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03360344
Brief Title
Non-surgical Intervention for Carpal Tunnel Syndrome
Official Title
Effects on Occupational Performance Through Dorsal Application of Kinesio Tape for Musculoskeletal Disorder - Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Susceptibility to
Keywords
carpal tunnel syndrome, pain, numbness, kinesio tape

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled trial
Masking
Participant
Masking Description
Participants do not know which group they will be randomly assigned
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Tape
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kinesio 12 inch Tape
Intervention Description
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
Intervention Name(s)
Kinesio 4 inch Tape
Intervention Description
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
Intervention Name(s)
Cock up Splint and Lumbrical exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NRS Pain)
Description
Numerical Pain Rating Scale (NRS Pain) involves patient circling a number from 0-10 with "0" meaning no pain and "5" moderate pain, and "10" is worst possible pain. The NRS is a segmented numeric scale, which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. Higher scores indicate greater pain intensity.
Time Frame
change between baseline and 3 weeks
Title
Visual Analog Scale for Pain (VAS Pain)
Description
The Visual Analogue Scale (VAS) is unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS measures participants perception of pain on a continuous scale. Individuals place a mark on a 10cm-long line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. These are measured every 3 days for 3 weeks from baseline in the forearm, wrist and fingers.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Grip Strength and Pinch Strength
Description
Grip strength is measured by Jamar Dynamometer hydraulic gauge following standard protocol. A Jamar hydraulic pinch meter gauge is used to measure finger strength in the following positions: Lateral pinch, pad to pad, and 3 Jaw-chuck pinch positions are used. Grip and pinch strength will be measured every 3 days for 3 weeks from baseline.
Time Frame
change between baseline and 3 weeks
Title
Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS)
Description
The Boston Carpal Tunnel Questionnaire (BCTQ SS) is a standardised, patient-based outcome measure of symptom severity in patients with carpal tunnel syndrome. The questionnaire has 11 questions and uses a five-point rating scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline.
Time Frame
change between baseline and 3 weeks
Title
Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS)
Description
The Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) is self report 8-item questionnarie on functional activities for individuals with carpal tunnel, which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline.
Time Frame
3-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grenith Zimmerman, PhD
Organizational Affiliation
Loma Linda University
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Non-surgical Intervention for Carpal Tunnel Syndrome

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