- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279015
The Effect Of Kinesio Tape In Chronic Neck Pain
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional rehabilitation treatment
Conventional physiotherapy program, consisting of standardised active (exercise) and passive (hotpack, ultrasound, conventional TENS) physical therapy methods, was applied by the same physiotherapist.
|
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".
Other Names:
|
Active Comparator: Kinesio tape procedure
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.
|
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".
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Evaluations were made on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014SBE013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Chronic Neck Pain
-
The University of Hong KongActive, not recruitingChronic Low Back Pain | Chronic Neck PainHong Kong
-
Massachusetts General HospitalCompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
Turku University HospitalCompletedChronic Low Back Pain | Chronic Neck Pain
-
Şenay ÖzdolapZonguldak Bulent Ecevit UniversityCompletedNeck Pain | Chronic Neck PainTurkey
-
KTO Karatay UniversityCompletedChronic Neck PainTurkey
-
Cairo UniversityCompletedChronic Mechanical Neck PainEgypt
-
Cairo UniversityCompletedChronic Non-Specific Neck PainEgypt
-
Beijing Sport UniversityCompletedChronic Non-specific Neck PainChina
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH); United States...CompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
RANDUniversity of California, Los AngelesCompletedChronic Low Back Pain | Chronic Neck PainUnited States
Clinical Trials on Kinesio tape procedure
-
University Rovira i VirgiliCompleted
-
Haydarpasa Numune Training and Research HospitalCompletedMyofascial Pain Syndrome | Myofascial Trigger Point PainTurkey
-
Norwegian School of Sport SciencesCompletedMuscle Weakness | Shoulder PainNorway
-
Paulista UniversityCompleted
-
Cairo UniversityCompletedPost Mastectomy Complications
-
Mayo ClinicCompleted
-
Paulista UniversityCompleted
-
IRCCS San RaffaeleUnknownBreast Cancer | Edema | Seroma | Mastectomy | Breast ImplantationItaly
-
Leandro PiresUnknown
-
King Saud UniversityCompletedChronic Ankle InstabilitySaudi Arabia