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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04279015
Other study ID # 2014SBE013
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 1, 2014
Est. completion date September 18, 2017

Study information

Verified date March 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date September 18, 2017
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Kinesio tape procedure
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".

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
Primary Pressure pain threshold 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.
Primary 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. 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.
Primary Isometric muscle strengths 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.
Primary 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. 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.
Primary 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. 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 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. 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 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. 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 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. 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 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. Evaluations were made on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
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