NCT04039581

Brief Summary

Aim of the study was to investigate the effect of Kinesio taping application on upper trapezius muscle after cervical spine surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable pain

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

July 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 19, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

July 24, 2019

Last Update Submit

January 30, 2025

Conditions

Keywords

Kinesio TapePainFunctionalityCervical Spine Surgery

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Neck pain intensity will be assessed with Visual Analog Scale (VAS).The VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 \[100-mm scale\]) on the right side.The patient was asked to mark the line point that represented his or her current pain.

    Change from baseline to two weeks after the surgery

  • Pain pressure threshold

    Pain pressure threshold of the trapezius muscle will be evaluated by digital pressure algometry. In the process, three measurements will be taken and the average value will be taken as reference.

    Change from baseline to two weeks after the surgery

Secondary Outcomes (4)

  • Range of Motion (ROM)

    Change from baseline to two weeks after the surgery

  • Disability

    Change from baseline to two weeks after the surgery

  • Health Related Quality of Life Score

    Change from baseline to two weeks after the surgery

  • Functionality Score

    Change from baseline to two weeks after the surgery

Study Arms (3)

Group 1: Kinesio Taping and Conventional treatment

EXPERIMENTAL

The number of participants in this group is anticipated to be 30. The treatment method for this group is the conventional treatment + KT (Kinesio Taping) (Space Correction). In the conventional treatment therapeutic exercises (active and passive Range Of Motion (ROM) and strengthening exercise of the neck and shoulder) and TENS (Transcutaneous electrical nerve stimulation) applications on the painful area, every day and 2 channels with 4 electrodes in the acute period (first 72 hours) will be applied. These exercises will be taught to participants from the first treatment session and will be performed under the supervision of a physiotherapist. In KT technique, while participants are sitting on the edge of the bed, the shoulder area will be depressed and I banding will be done by applying 25-50% tension horizontally in this position on the upper trapezius muscle.

Other: Kinesio TapingOther: Conventional treatment

Group 2: Conventional treatment

ACTIVE COMPARATOR

The number of participants in this group are anticipated to be 30. This group will be receiving only conventional treatment. In the conventional treatment therapeutic exercises (active and passive range of motion (ROM) and strengthening exercise of the neck and shoulder) and TENS (Transcutaneous electrical nerve stimulation) applications on the painful area, every day and 2 channels with 4 electrodes in the acute period (first 72 hours) will be applied. These exercises will be taught to participants from the first treatment session and will be performed under the supervision of a physiotherapist.

Other: Conventional treatment

Group 3: Kinesio Taping

ACTIVE COMPARATOR

The number of participants in this group are anticipated to be 30. This group will be receiving only Kinesio Taping (Space Correction). In kinesio taping technique while participants are sitting on the edge of the bed, the shoulder area will be depressed and I banding will be done by applying 25-50% tension horizontally in this position on the upper trapezius muscle.

Other: Kinesio Taping

Interventions

Kinesio Taping (Space Correction).

Group 1: Kinesio Taping and Conventional treatmentGroup 3: Kinesio Taping

Therapeutic exercises (active and passive range of motion (ROM) and strengthening exercise ) and TENS (Transcutaneous electrical nerve stimulation) applications

Group 1: Kinesio Taping and Conventional treatmentGroup 2: Conventional treatment

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be voluntary participation in the study,
  • Aged 25-75 years old,
  • To be diagnosed with cervical disc herniation, cervical stenosis and cervical spondylolisthesis
  • No mental problem, sensory or motor aphasia in order to understand and answer the evaluation questions correctly.

You may not qualify if:

  • History of surgery,
  • Allergic reaction to kinesio taping,
  • Primary or metastatic neoplasm in cervical spine,
  • History of different treatment for neck pain during the study period,
  • Individuals with any congenital deformity in the spine,
  • Having any rheumatologic, neurological and orthopedic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçeşehir University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Bartleson JD. Low Back Pain. Curr Treat Options Neurol. 2001 Mar;3(2):159-168. doi: 10.1007/s11940-001-0051-4.

    PMID: 11180753BACKGROUND
  • Gonzalez-Iglesias J, Fernandez-de-Las-Penas C, Cleland JA, Huijbregts P, Del Rosario Gutierrez-Vega M. Short-term effects of cervical kinesio taping on pain and cervical range of motion in patients with acute whiplash injury: a randomized clinical trial. J Orthop Sports Phys Ther. 2009 Jul;39(7):515-21. doi: 10.2519/jospt.2009.3072.

    PMID: 19574662BACKGROUND

Related Links

MeSH Terms

Conditions

PainIntervertebral Disc DisplacementSpondylosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Tuğba KURU ÇOLAK

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 31, 2019

Study Start

October 19, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations