Neck PainNCT05395572
The Effects of Kinesio® Tape on Neck Pain and Disability
A study testing Kinesio® Tape in people with Neck Pain, run by North Dakota State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Kinesio® Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 17 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck Disability Index Score of more than 14
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University
Fargo, North Dakota, 58108
About this study
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.
- Conditions
- Neck Pain
- Being tested
- Kinesio® Tape
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio® TapeDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Tape | Experimental | Kinesio tape will be applied to the neck to help facilitate underactive muscles and ROM will be assessed Receives: Device: Kinesio® Tape |
| Control | No intervention | ROM will be assessed before tape application to determine any changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Patient-reported neck pain
Measured: 1 day
Headaches Associated With Personal Protective Equipment
Mask associated pain questionnaire
Measured: 1 day
Dartfish
2-dimensional motion analysis
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start17 Mar 2021
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395572
- Sponsor's protocol ID
- IRB0003476
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesio® Tape on Neck Pain and Disability
- ClinicalTrials.gov ID
- NCT05395572
- Acronym / sponsor ID
- IRB0003476
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tape | Experimental | Device: Kinesio® TapeKinesio tape will be applied to the neck to help facilitate underactive muscles and ROM will be assessed |
| Control | No intervention | –ROM will be assessed before tape application to determine any changes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neck Disability Index Score of more than 14
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio® TapeIn 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). | Device | Tape |
Primary outcome
Neck Disability Index
Time frame: 1 day
Patient-reported neck pain
Headaches Associated With Personal Protective Equipment
Time frame: 1 day
Mask associated pain questionnaire
Dartfish
Time frame: 20 minutes
2-dimensional motion analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio® Tape in people with Neck Pain, run by North Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.