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PainNCT04039581

KT® in Patients With Cervical Spine Surgery

A study testing Kinesio Taping and Conventional treatment in people with Pain and Cervical Spinal Stenosis, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Pain, Cervical Spinal Stenosis, Disc, Herniated
What is being tested?
Kinesio Taping and Conventional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Oct 2019to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bahçeşehir University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Short-Term Effects of Kinesio Taping® on Pain and Functionality in Patients With Cervical Spine Surgery

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

Read the detailed description

Patients will be randomly divided into three groups. The first group will receive conservative treatment and Kinesio Taping application. The second group will receive conservative treatment and the third group will receive only Kinesio taping application. The treatment procedure will continue for post-operatively three days and assessments will be done four times; before the surgery, post-operative 1st day, postoperative 3rd day and two weeks after surgery. Data will be recorded on patient assessment file and transferred to the computer. Data analysis will be performed with SPSS.22.

Being tested
Kinesio Taping, Conventional treatment
Keywords
Kinesio Tape, Pain, Functionality, Cervical Spine Surgery
Medical subject headings
Pain, Intervertebral Disc Displacement, Spondylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesio TapingOther

    Kinesio Taping (Space Correction).

  • Conventional treatmentOther

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

Study groups in NCT04039581
Study groupRoleWhat they receive
Group 1: Kinesio Taping and Conventional treatmentExperimentalThe 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.
Receives: Other: Kinesio Taping; Other: Conventional treatment
Group 2: Conventional treatmentActive comparatorThe 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.
Receives: Other: Conventional treatment
Group 3: Kinesio TapingActive comparatorThe 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.
Receives: Other: Kinesio Taping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to two weeks after the surgery

  2. 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.

    Measured: Change from baseline to two weeks after the surgery

Secondary outcomes (4)

  1. Range of Motion (ROM)

    Range of motion will be measured with a goniometer. The goniometer is valid and reliable tool.

    Measured: Change from baseline to two weeks after the surgery

  2. Disability

    Disability will be assessed with Neck Pain and Disability Scale (NPAD). Turkish version of the Neck Pain and Disability Scale is including 20 items which measure the intensity of neck pain and related disability. Item scores range from 0 to 5. Each item has a 10-cm visual analog scale. It has six major divisions divided into equal intervals by vertical bars. The questions are investigating the relationship between neck pain severity and pain on occupational life, recreational activities, social and functional aspects of living, and emotional factors. High scores indicate serious disabilities.

    Measured: Change from baseline to two weeks after the surgery

  3. Health Related Quality of Life Score

    Quality of life will be assessed with Short Form-36 (SF-36).The SF-36, It generates 8 subscales and two summary scores.The 8 subscales are; physical functioning, role limitations due to physical health, role, limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perceptions. The two summary scores are the physical component summary and the mental component summary. Scoring the SF-36 consists of 36 items. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

    Measured: Change from baseline to two weeks after the surgery

  4. Functionality Score

    The functionality will be assessed with Upper Extremity Functional Index-15 (UEFI-15). The UEFI-15 consists of 15 questions on a 5- point rating scale assessing level of difficulty in performing activities of daily living using the upper extremities. 0 indicates extreme difficulty while 4 indicates no difficulty wit a task. The scores given to the 15 questions are added to give the highest possible score of 60 and the lowest possible score is 0. A lower score indicates that the person is reporting increased difficulty with the activities as a result of their upper limb functionality.

    Measured: Change from baseline to two weeks after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2019
  2. Study start19 Oct 2019
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04039581
Sponsor's protocol ID
Marmara University
Status last verified
Jan 2025
First submitted
24 Jul 2019
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 11180753

  • 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.

    PubMed 19574662

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio Taping and Conventional treatment in people with Pain and Cervical Spinal Stenosis, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Change from baseline to two weeks after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04039581, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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KT® in Patients With Cervical Spine Surgery | AzTrials