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The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers

Primary Purpose

Neck Pain, Back Pain, Occupational Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
taping
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring taping, Kinesio® Tex, functionality, work performance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Volunteering to participate in the study Having signed the voluntary consent form. Being between the ages of 25-55 Working in home health services for at least 2 years Reporting symptoms of localized pain and discomfort in the neck-back region lasting at least 1 week in the last 12 months Exclusion Criteria: The participant's wish to terminate the study Receiving physical therapy for neck-back pain in the last 3 months Findings such as pins and needles, numbness and tingling in the upper extremity Having an allergy to taping Presence of a known specific disease that may cause chronic neck-back pain (nerve root compression, postoperative condition in the neck and shoulder regions, peripheral entrapment neuropathy, cervical spine anomaly, severe neck trauma such as whiplash, malignancy, migraine). Alcohol and drug addiction Psychological conditions that may cause physical burden and recent major operations Presence of a skin disease that will affect the neck and back area

Sites / Locations

  • İstanbul Büyükşehir BelediyesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

taping group

Arm Description

The exercise program to be given to the participants consists of stretching, strengthening and postural exercises for the muscles in the neck-back region. While doing the posture exercises, the participants will be asked to do the exercises in front of the mirror in order to correct the wrong postural posture and to provide relaxation.

In addition to the exercises, the Kinesio® Tex taping application will remain on the body for 4 days, and then it will be applied 6 times in total, with a 3-day break.

Outcomes

Primary Outcome Measures

Neck Pain Disability Index Questionnaire
The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted
The Quebec Back Pain Disability Scale (QBPDS)
The problems caused by back pain are evaluated with 20 different activities from the scale. Its rating is between 0-5. 0 points are expressed as "not difficult at all" and 5 points are expressed as "it is not possible to do". The total score is obtained by summing the answers given to the 20 activities.
Pittsburgh Sleep Quality Index (PSQI)
In the evaluation of the Pittsburgh Sleep Quality Index, 18 items are included in the scoring. The scale has a total of 7 components: sleep duration, habitual sleep efficiency, subjective sleep quality, sleep delay, sleep disturbance, daytime dysfunction, and sleep medication use. Some of the components consist of a single item, while others consist of groupings of several items. Each item scores between 0-3 and the sum of the scores of the 7 components forms the PSQI score. The total score is between 0-21. A high total score indicates a low sleep quality. A total PSQI score of ≤5 indicates "good sleep quality", and >5 indicates "poor sleep quality".
Work Role Functioning Questionnaire (WRFQ)
The scale evaluates the difficulties experienced by people while doing their jobs as a percentage of time. In addition, the questionnaire evaluates the effectiveness of the treatment applied. It has five sub-headings as work program (5 questions), Efficiency (7 questions), Physical (6 questions), Mental (6 questions) and Social status (3 questions). It is a scale with 27 questions in total. This scale assesses how often individuals have had difficulties while doing their jobs in the last four weeks. If the expression defined in the question is not related to the profession of the person, he is asked to mark the option "It is not suitable for my profession".

Secondary Outcome Measures

Full Information

First Posted
August 11, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06003842
Brief Title
The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers
Official Title
The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar 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 examine the effect of Kinesio® Tex application on pain, functionality, sleep quality and work performance in drivers experiencing neck-back pain.
Detailed Description
50 active drivers will be included in the study. The drivers included in the study will be randomly divided into two groups as exercise group and taping group. The home exercise program will be visually explained to both groups and the exercises will be sent to the participants as video. Kinesio® Tex will also be applied to the banding group. Evaluations will be made before treatment and after 6 weeks of treatment. Within the scope of the evaluation, demographic information of the patients, work experience, daily working time, dominant hand, education information (university / high school), type of vehicle used, habit of leaning elbow on the left window, diseases and drugs used, smoking and alcohol use, given after mutual interview will be obtained by recording the answers. Joint range of motion, manual muscle test, pain severity of the individuals participating in the study with the Visual Analog Scale, neck functionality assessment with the Neck Disability Indicator, back functionality assessment with the Quebec Back-Low Back Pain Disability Scale, sleep quality assessment with the Pittsburgh Sleep Quality Index, work performance assessment To be assessed by the Work Role Functioning Questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Back Pain, Occupational Diseases
Keywords
taping, Kinesio® Tex, functionality, work performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two different Kinesio® Tex taping techniques were applied to the participants. One of these applications is for the upper trapezius muscle and the other is a taping technique applied to support the correct postural posture and trapezius muscle. Banding was applied bilaterally.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
The exercise program to be given to the participants consists of stretching, strengthening and postural exercises for the muscles in the neck-back region. While doing the posture exercises, the participants will be asked to do the exercises in front of the mirror in order to correct the wrong postural posture and to provide relaxation.
Arm Title
taping group
Arm Type
Experimental
Arm Description
In addition to the exercises, the Kinesio® Tex taping application will remain on the body for 4 days, and then it will be applied 6 times in total, with a 3-day break.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Stretching exercises for flexion, extension, lateral flexion and rotation, upper trapezius, levator scapula and pectoralis major muscles will be applied in the maximum range of motion of the cervical region in three planes. To increase the mobility of the thoracic region, exercises for thoracic mobility will be given. Strengthening exercises will focus on the back muscles. The resistance of the exercises will be determined according to the individual capacities and strain levels of the participants, and it will be requested to increase the amount of resistance applied depending on the functional developments. You will be asked to perform the exercises twice a day, with 10 repetitions, for 6 weeks. Participants will be asked to hold the position for 3-5 seconds and return to the starting position while doing the strengthening exercises.
Intervention Type
Other
Intervention Name(s)
taping
Intervention Description
After the Kinesio® Tex application, it will remain in the body for 4 days, and then it will be applied 6 times in total, with a 3-day break. It will be stated that the area to be banded should not contain substances such as cream, hair or oil. Upper Trapeze taping will be performed by applying one end of the Y tape to the upper trapeze and the other end to the lower part of the spina scapula, by affixing the tape to the head of the shoulder while standing upright, and keeping the participant's ear tilted towards the other ear as much as possible. Before attaching the rest of the tape, the participant will be asked to bring the shoulder blades closer together and stand upright. In this position, using a mechanical correction technique along the medial line of the scapula along the spine, the rest of the tape will be adhered as an I tape with 35-50% tension.
Primary Outcome Measure Information:
Title
Neck Pain Disability Index Questionnaire
Description
The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted
Time Frame
8 weeks
Title
The Quebec Back Pain Disability Scale (QBPDS)
Description
The problems caused by back pain are evaluated with 20 different activities from the scale. Its rating is between 0-5. 0 points are expressed as "not difficult at all" and 5 points are expressed as "it is not possible to do". The total score is obtained by summing the answers given to the 20 activities.
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
In the evaluation of the Pittsburgh Sleep Quality Index, 18 items are included in the scoring. The scale has a total of 7 components: sleep duration, habitual sleep efficiency, subjective sleep quality, sleep delay, sleep disturbance, daytime dysfunction, and sleep medication use. Some of the components consist of a single item, while others consist of groupings of several items. Each item scores between 0-3 and the sum of the scores of the 7 components forms the PSQI score. The total score is between 0-21. A high total score indicates a low sleep quality. A total PSQI score of ≤5 indicates "good sleep quality", and >5 indicates "poor sleep quality".
Time Frame
8 weeks
Title
Work Role Functioning Questionnaire (WRFQ)
Description
The scale evaluates the difficulties experienced by people while doing their jobs as a percentage of time. In addition, the questionnaire evaluates the effectiveness of the treatment applied. It has five sub-headings as work program (5 questions), Efficiency (7 questions), Physical (6 questions), Mental (6 questions) and Social status (3 questions). It is a scale with 27 questions in total. This scale assesses how often individuals have had difficulties while doing their jobs in the last four weeks. If the expression defined in the question is not related to the profession of the person, he is asked to mark the option "It is not suitable for my profession".
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteering to participate in the study Having signed the voluntary consent form. Being between the ages of 25-55 Working in home health services for at least 2 years Reporting symptoms of localized pain and discomfort in the neck-back region lasting at least 1 week in the last 12 months Exclusion Criteria: The participant's wish to terminate the study Receiving physical therapy for neck-back pain in the last 3 months Findings such as pins and needles, numbness and tingling in the upper extremity Having an allergy to taping Presence of a known specific disease that may cause chronic neck-back pain (nerve root compression, postoperative condition in the neck and shoulder regions, peripheral entrapment neuropathy, cervical spine anomaly, severe neck trauma such as whiplash, malignancy, migraine). Alcohol and drug addiction Psychological conditions that may cause physical burden and recent major operations Presence of a skin disease that will affect the neck and back area
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan ZENGİ
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
İstanbul Büyükşehir Belediyesi
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan ZENGİ

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12117750
Citation
Pope MH, Goh KL, Magnusson ML. Spine ergonomics. Annu Rev Biomed Eng. 2002;4:49-68. doi: 10.1146/annurev.bioeng.4.092101.122107. Epub 2002 Mar 22.
Results Reference
background
PubMed Identifier
19787503
Citation
Rehn B, Nilsson T, Lundstrom R, Hagberg M, Burstrom L. Neck pain combined with arm pain among professional drivers of forest machines and the association with whole-body vibration exposure. Ergonomics. 2009 Oct;52(10):1240-7. doi: 10.1080/00140130902939889.
Results Reference
background
PubMed Identifier
24998325
Citation
Bovenzi M. A prospective cohort study of neck and shoulder pain in professional drivers. Ergonomics. 2015;58(7):1103-16. doi: 10.1080/00140139.2014.935487. Epub 2014 Jul 7.
Results Reference
background
PubMed Identifier
10688485
Citation
Chapline JF, Ferguson SA, Lillis RP, Lund AK, Williams AF. Neck pain and head restraint position relative to the driver's head in rear-end collisions. Accid Anal Prev. 2000 Mar;32(2):287-97. doi: 10.1016/s0001-4575(99)00126-8.
Results Reference
background
PubMed Identifier
23088702
Citation
Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.
Results Reference
background

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The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers

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