NCT05395572

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 2, 2021

Last Update Submit

May 24, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Neck Disability Index

    Patient-reported neck pain

    1 day

  • Headaches Associated With Personal Protective Equipment

    Mask associated pain questionnaire

    1 day

  • Dartfish

    2-dimensional motion analysis

    20 minutes

Study Arms (2)

Tape

EXPERIMENTAL

Kinesio tape will be applied to the neck to help facilitate underactive muscles and ROM will be assessed

Device: Kinesio® Tape

Control

NO INTERVENTION

ROM will be assessed before tape application to determine any changes

Interventions

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).

Tape

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck Disability Index Score of more than 14

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58108, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

May 27, 2022

Study Start

March 17, 2021

Primary Completion

May 17, 2021

Study Completion

May 17, 2021

Last Updated

May 27, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations