Chronic Neck PainPhase 2NCT04279015

The Effect Of Kinesio Tape In Chronic Neck Pain

A Phase 2 study testing Kinesio tape procedure in people with Chronic Neck Pain, run by Pamukkale University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study was planned to investigate the efficacy of treatment for Kinesio tape application in chronic neck pain individuals. A total of 44 individuals were randomly divided into two groups (study group: 22, control group: 22). Read more about this study

Who is it for?: Ages 30 to 55 years
Conditions the study is for: Chronic Neck Pain
What is being tested?: Kinesio tape procedure
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: No sites listed yet
Study dates: 1 Apr 2014to 18 Sep 2017
Phase: Phase 2
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 30 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Being between the ages of 30-55,
Having been suffering from neck pain for at least three months,
Getting at least 5 points from the Neck Disability Index,
Having pain between the superior nuchal line and spina scapula,
Neck Pain Task Force, which consists of four levels to be at the first and second level.

Who cannot join

Presence of conditions that will prevent evaluation or communication (such as cognitive problems),
Being illiterate,
Having had physiotherapy from the neck, back or waist region in the last six months,
Having had cervical region and spine surgery,
Presence of impingement or thoracic outlet syndrome, malignancy, fractured, systemic autoimmune diseases, neurological problems and diagnosed psychiatric diseases that will prevent evaluation and treatment.

About this study

Official title: The Effect Of Kinesio Tape In Chronic Neck Pain: Randomise Controlled Study

This study was planned to investigate the efficacy of treatment for Kinesio tape application in chronic neck pain individuals.

A total of 44 individuals were randomly divided into two groups (study group: 22, control group: 22). Conventional physiotherapy methods including active (exercise) and passive (hotpack, ultrasound and conventional transcutaneous electrical nerve stimulation (TENS)) treatment were applied to all subjects for 15 sessions (5 days a week). In addition to the individuals in the study group, Kinesio tape application was performed at the end of each session. Pain (Visual Analogue Scale), pressure pain threshold (digital algometer), range of motion (CROM device), muscle strength (Hand-Held Dynamometer), muscle endurance, pectoralis minor muscle length, quality of life (Nottingham Health Profile) and depressive symptoms (Beck Depression Scale) assessments were performed before treatment, on the second day of treatment and after treatment (after three weeks). Treatment satisfaction with individuals (Visual Analogue Scale) was assessed on the 2nd day of treatment and post-treatment (after three weeks).

Read the detailed description

In the literature, it is seen that Kinesio tape is used in problems such as knee pain, chronic low back pain, neck pain, shoulder pain and common musculoskeletal pain. Some studies with individuals with low back and neck pain show positive effects of Kinesio tape on pain reduction and recovery in disability. However, studies are reporting the opposite of these results. The number of studies in the literature is insufficient to create clinical evidence regarding the use of Kinesio tape in patients with neck pain. By considering this deficiency, the purpose of our study was to investigate the effect of Kinesio tape applied together with conventional physiotherapy methods in individuals with chronic neck pain.

Conditions: Chronic Neck Pain
Being tested: Kinesio tape procedure
Keywords: Neck Pain, Kinesio tape, Pain, Quality of Life
Medical subject headings: Neck Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kinesio tape procedureProcedure or surgery
Also called Conventional rehabilitation treatment
Conventional rehabilitation treatment: Hotpack, ultrasound, conventional TENS and exercise for neck pain.
Kinesio taping procedure: Inhibition technique with 15-25% tension to the upper trapezius muscle with I tape to reduce pain and muscle spasm, to support the weak muscles, Facilitation technique with Y-band with 15-35% tension to the cervical paravertebral muscles, and X-band with 15-35% tension to the rhomboideus major muscle technique and the correction technique was applied to the region where the individual defined the most pain and tenderness in palpation by using the "star application".

Study groups in NCT04279015
Study group	Role	What they receive
Conventional rehabilitation treatment	Active comparator	Conventional physiotherapy program, consisting of standardised active (exercise) and passive (hotpack, ultrasound, conventional TENS) physical therapy methods, was applied by the same physiotherapist. Receives: Procedure: Kinesio tape procedure
Kinesio tape procedure	Active comparator	In addition to the conventional physiotherapy program Kinesio tape was performed every day of conventional treatment immediately after the session ended by the same physiotherapist. Receives: Procedure: Kinesio tape procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Scale
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Visual Analogue Scale was used to evaluate pain intensity. The highest score is 10, the lowest is 0. High scores indicate that pain intensity is high.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Pressure pain threshold
Pressure pain threshold was evaluated with an objective method, digital algometer. The results are recorded in Newton / cm2.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Cervical range of motion
Cervical range of motion was evaluated with the Cervical Range of Motion device.All movements were actively carried out, and measurement results were recorded in degrees.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Isometric muscle strengths
Isometric muscle strengths of the cervical region were evaluated by Hand-Held Dynamometer. The result measurements were recorded in Newton.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
The pectoralis minor muscle shortness
The pectoralis minor muscle shortness of the participants was evaluated with a standard bilateral ruler.Muscle shortness was recorded in centimetres.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
The endurance of the deep neck flexor muscles
The endurance of the deep neck flexor muscles with a chronometer, muscle endurance was recorded in seconds.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.

Secondary outcomes (4)

Neck Disability Index
Disability levels of the participants were assessed with the Neck Disability Index.The highest score is 50, the lowest is 0. High scores indicate that disability level is high.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Nottingham Health Profile
Quality of life were assessed with Nottingham Health Profile.The highest score is 600, the lowest is 0. The increase in score indicates worse quality of life.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Beck Depression Inventory
The emotional status were assessed with Beck Depression Inventory. The highest score that can be obtained is 63, the lowest is 0. It has been reported that individuals scoring 17 points or more have severe depressive symptoms that require treatment.
Measured: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Treatment satisfaction
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Treatment satisfaction were assessed with the Visual Analogue Scale. The highest score is 10, the lowest is 0. High scores indicate that treatment satisfaction is high.
Measured: Evaluations were made on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201418 Sep 2017

First posted20 Feb 2020
Study start1 Apr 2014
Primary completion31 Dec 2015
Study completion18 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Neck PainStudies of the same condition, open and under way.
More trials run by Pamukkale UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: pretest-posttest control groups in randomized parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04279015
Sponsor's protocol ID: 2014SBE013
Status last verified: Mar 2021
First submitted: 10 Feb 2020
Last updated: 11 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
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Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
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Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
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Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
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All Chronic Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect Of Kinesio Tape In Chronic Neck Pain: Randomise Controlled Study
ClinicalTrials.gov ID: NCT04279015
Acronym / sponsor ID: 2014SBE013
Conditions: Chronic Neck Pain
Keywords: Neck Pain, Kinesio tape, Pain, Quality of Life
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Pamukkale UniversityUniversity, hospital or other
Study start: 1 Apr 2014 (actual)
Primary completion: 31 Dec 2015 (actual)
Study completion: 18 Sep 2017 (actual)
First posted: 20 Feb 2020 (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 was planned to investigate the efficacy of treatment for Kinesio tape application in chronic neck pain individuals.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: pretest-posttest control groups in randomized parallel groups

Arm	Type	Receives
Conventional rehabilitation treatment	Active comparator	Procedure: Kinesio tape procedureConventional physiotherapy program, consisting of standardised active (exercise) and passive (hotpack, ultrasound, conventional TENS) physical therapy methods, was applied by the same physiotherapist.
Kinesio tape procedure	Active comparator	Procedure: Kinesio tape procedureIn addition to the conventional physiotherapy program Kinesio tape was performed every day of conventional treatment immediately after the session ended by the same physiotherapist.

Who may qualify

Ages: 30 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Being between the ages of 30-55,
Having been suffering from neck pain for at least three months,
Getting at least 5 points from the Neck Disability Index,
Having pain between the superior nuchal line and spina scapula,
Neck Pain Task Force, which consists of four levels to be at the first and second level.

Key exclusion criteria (5 listed)

Presence of conditions that will prevent evaluation or communication (such as cognitive problems),
Being illiterate,
Having had physiotherapy from the neck, back or waist region in the last six months,
Having had cervical region and spine surgery,
Presence of impingement or thoracic outlet syndrome, malignancy, fractured, systemic autoimmune diseases, neurological problems and diagnosed psychiatric diseases that will prevent evaluation and treatment.

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 tape procedureAlso: Conventional rehabilitation treatmentConventional rehabilitation treatment: Hotpack, ultrasound, conventional TENS and exercise for neck pain. Kinesio taping procedure: Inhibition technique with 15-25% tension to the upper trapezius muscle with I tape to reduce pain and muscle spasm, to support the weak muscles, Facilitation technique with Y-band with 15-35% tension to the cervical paravertebral muscles, and X-band with 15-35% tension to the rhomboideus major muscle technique and the correction technique was applied to the region where the individual defined the most pain and tenderness in palpation by using the "star application".	Procedure or surgery	Conventional rehabilitation treatment, Kinesio tape procedure

Primary outcome

Visual Analogue Scale
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Visual Analogue Scale was used to evaluate pain intensity. The highest score is 10, the lowest is 0. High scores indicate that pain intensity is high.
Pressure pain threshold
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Pressure pain threshold was evaluated with an objective method, digital algometer. The results are recorded in Newton / cm2.
Cervical range of motion
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Cervical range of motion was evaluated with the Cervical Range of Motion device.All movements were actively carried out, and measurement results were recorded in degrees.
Isometric muscle strengths
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Isometric muscle strengths of the cervical region were evaluated by Hand-Held Dynamometer. The result measurements were recorded in Newton.
The pectoralis minor muscle shortness
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
The pectoralis minor muscle shortness of the participants was evaluated with a standard bilateral ruler.Muscle shortness was recorded in centimetres.
The endurance of the deep neck flexor muscles
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
The endurance of the deep neck flexor muscles with a chronometer, muscle endurance was recorded in seconds.

4 secondary outcomes

Neck Disability Index
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Nottingham Health Profile
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Beck Depression Inventory
Time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
Treatment satisfaction
Time frame: Evaluations were made on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.

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 11 Mar 2021.
Individual participant dataSharing planned: No

Related trials for Chronic Neck Pain

Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Kinesio tape procedure in people with Chronic Neck Pain, run by Pamukkale University.

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 5 inclusion and 5 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Visual Analogue Scale (time frame: Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04279015.

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 11 Mar 2021.