The Effect Of Kinesio Tape In Chronic Neck Pain
Primary Purpose
Chronic Neck Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Kinesio tape procedure
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Neck Pain focused on measuring Neck Pain, Kinesio tape, Pain, Quality of Life
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional rehabilitation treatment
Kinesio tape procedure
Arm Description
Conventional physiotherapy program, consisting of standardised active (exercise) and passive (hotpack, ultrasound, conventional TENS) physical therapy methods, was applied by the same physiotherapist.
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.
Outcomes
Primary Outcome Measures
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.
Pressure pain threshold
Pressure pain threshold was evaluated with an objective method, digital algometer. The results are recorded in Newton / cm2.
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.
Isometric muscle strengths
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
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
The endurance of the deep neck flexor muscles with a chronometer, muscle endurance was recorded in seconds.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04279015
Brief Title
The Effect Of Kinesio Tape In Chronic Neck Pain
Official Title
The Effect Of Kinesio Tape In Chronic Neck Pain: Randomise Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
September 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Neck Pain, Kinesio tape, Pain, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
pretest-posttest control groups in randomized parallel groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional rehabilitation treatment
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy program, consisting of standardised active (exercise) and passive (hotpack, ultrasound, conventional TENS) physical therapy methods, was applied by the same physiotherapist.
Arm Title
Kinesio tape procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Kinesio tape procedure
Other Intervention Name(s)
Conventional rehabilitation treatment
Intervention Description
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".
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
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.
Title
Pressure pain threshold
Description
Pressure pain threshold was evaluated with an objective method, digital algometer. The results are recorded in Newton / cm2.
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.
Title
Cervical range of motion
Description
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.
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.
Title
Isometric muscle strengths
Description
Isometric muscle strengths of the cervical region were evaluated by Hand-Held Dynamometer. The result measurements were recorded in Newton.
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.
Title
The pectoralis minor muscle shortness
Description
The pectoralis minor muscle shortness of the participants was evaluated with a standard bilateral ruler.Muscle shortness was recorded in centimetres.
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.
Title
The endurance of the deep neck flexor muscles
Description
The endurance of the deep neck flexor muscles with a chronometer, muscle endurance was recorded in seconds.
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.
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
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.
Title
Nottingham Health Profile
Description
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.
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.
Title
Beck Depression Inventory
Description
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.
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.
Title
Treatment satisfaction
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect Of Kinesio Tape In Chronic Neck Pain
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