NCT06003842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2023

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

August 11, 2023

Last Update Submit

March 12, 2024

Conditions

Keywords

tapingKinesio® Texfunctionalitywork performance

Outcome Measures

Primary Outcomes (4)

  • 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

    8 weeks

  • 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.

    8 weeks

  • 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".

    8 weeks

  • 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".

    8 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

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.

Other: exercise

taping group

EXPERIMENTAL

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.

Other: exerciseOther: taping

Interventions

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.

control grouptaping group
tapingOTHER

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.

taping group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study Having signed the voluntary consent form.
  • Being between the ages of 18-65
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Büyükşehir Belediyesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 12117750BACKGROUND
  • 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.

    PMID: 19787503BACKGROUND
  • 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.

    PMID: 24998325BACKGROUND
  • 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.

    PMID: 10688485BACKGROUND
  • 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.

    PMID: 23088702BACKGROUND

MeSH Terms

Conditions

Neck PainBack PainOccupational Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hakan ZENGİ

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 12, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations