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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05395572
Other study ID # IRB0003476
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2021
Est. completion date May 17, 2021

Study information

Verified date June 2021
Source North Dakota State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 17, 2021
Est. primary completion date May 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Kinesio® Tape
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).

Locations

Country Name City State
United States North Dakota State University Fargo North Dakota

Sponsors (1)

Lead Sponsor Collaborator
North Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck Disability Index Patient-reported neck pain 1 day
Primary Headaches Associated With Personal Protective Equipment Mask associated pain questionnaire 1 day
Primary Dartfish 2-dimensional motion analysis 20 minutes
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