- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039581
KT® in Patients With Cervical Spine Surgery
Short-Term Effects of Kinesio Taping® on Pain and Functionality in Patients With Cervical Spine Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey
- Bahçeşehir University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Kinesio Taping and Conventional treatment
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) relaxation technique (muscle inhibition technique). 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. |
Kinesio Taping relaxation technique (muscle inhibition technique)
Therapeutic exercises (active and passive range of motion (ROM) and strengthening exercise ) and TENS (Transcutaneous electrical nerve stimulation) applications
|
Active Comparator: Group 2: Conventional treatment
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.
|
Therapeutic exercises (active and passive range of motion (ROM) and strengthening exercise ) and TENS (Transcutaneous electrical nerve stimulation) applications
|
Active Comparator: Group 3: Kinesio Taping
The number of participants in this group are anticipated to be 30.
This group will be receiving only Kinesio Taping relaxation technique (muscle inhibition technique).
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.
|
Kinesio Taping relaxation technique (muscle inhibition technique)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: Change from baseline to two weeks after the surgery
|
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
Time Frame: Change from baseline to two weeks after the surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Related Quality of Life Score
Time Frame: Change from baseline to two weeks after the surgery
|
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.
|
Change from baseline to two weeks after the surgery
|
Functionality Score
Time Frame: Change from baseline to two weeks after the surgery
|
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.
|
Change from baseline to two weeks after the surgery
|
Range of Motion (ROM)
Time Frame: Change from baseline to two weeks after the surgery
|
Range of motion will be measured with a goniometer.
The goniometer is valid and reliable tool.
|
Change from baseline to two weeks after the surgery
|
Disability
Time Frame: Change from baseline to two weeks after the surgery
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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.
|
Change from baseline to two weeks after the surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Tuğba KURU ÇOLAK, Marmara University
Publications and helpful links
General Publications
- Bartleson JD. Low Back Pain. Curr Treat Options Neurol. 2001 Mar;3(2):159-168. doi: 10.1007/s11940-001-0051-4.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Marmara University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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