- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05395572
The Effects of Kinesio® Tape on Neck Pain and Disability
May 24, 2022 updated by: North Dakota State University
This study is a within-subjects design; therefore, the participant will serve as their own control.
Participants will be included in the study if they have neck pain or disability defined by a score of more than 14 on the Neck Disability Index.
They will be excluded if they have any diagnosed disc pathology.
A mask-associated pain questionnaire will be completed by the participants prior to the study to determine their perceived effect of mask-wearing on neck pain.
This questionnaire is adapted from the HAPPE study on mask-associated headache pain.
A baseline pain rating will be recorded a numerical pain scale.
Next, active cervical range of motion will be measured, three times in each direction to be averaged.
A pain rating will be recorded for pain during cervical motion.
Kinesio® Tape will be applied to activate the cervical extensor muscles.
The participant will sit with the tape on for 20 minutes, then active cervical range of motion and pain will be recored again.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
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North Dakota
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Fargo, North Dakota, United States, 58108
- North Dakota State University
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Neck Disability Index Score of more than 14
Exclusion Criteria:
- cervical disc pathology or injury
- previous neck surgery
- prior history of general medical conditions involving joints, muscles, bones or connective tissue such as fibromyalgia, osteoporosis, etc.
- an NDI score of less than 14 or more than 24
- reported allergies to Kinesio® Tex Tape or any other adhesive material
- any contraindications for the usage of Kinesio® Tape
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: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tape
Kinesio tape will be applied to the neck to help facilitate underactive muscles and ROM will be assessed
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In order to increase the activity of underactive muscles, the tape is applied from origin to insertion with a 15-25% tension.
The Kinesio® Tape mechanical muscle correction will be performed with one Y-strip of Kinesio® Tape over the bilateral cervical multifidus and semispinalis cervicis muscles, while also including portions of other cervical extensor muscles (the semispinalis capitis, splenius cervicis, levator scapulae, upper trapezius, longus coli, and splenius capitis).
|
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No Intervention: Control
ROM will be assessed before tape application to determine any changes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: 1 day
|
Patient-reported neck pain
|
1 day
|
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Headaches Associated With Personal Protective Equipment
Time Frame: 1 day
|
Mask associated pain questionnaire
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1 day
|
|
Dartfish
Time Frame: 20 minutes
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2-dimensional motion analysis
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 17, 2021
Primary Completion (Actual)
May 17, 2021
Study Completion (Actual)
May 17, 2021
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
May 24, 2022
First Posted (Actual)
May 27, 2022
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0003476
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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