KT® in Patients With Cervical Spine Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039581
• Other study ID #: Marmara University
• Status: Completed
• Phase: N/A
• Start date: October 19, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spinal Stenosis
• Cervical Spondylosis
• Disc, Herniated
• Intervertebral Disc Displacement
• Pain
• Spinal Stenosis
• Spondylosis

Intervention

Other:
• Kinesio Taping
Kinesio Taping relaxation technique (muscle inhibition technique)
• Conventional treatment
Therapeutic exercises (active and passive range of motion (ROM) and strengthening exercise ) and TENS (Transcutaneous electrical nerve stimulation) applications

Locations

Country	Name	City	State
Turkey	Bahçesehir University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Marmara University	Bahçesehir University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Range of Motion (ROM)	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
Secondary	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.	Change from baseline to two weeks after the surgery
Secondary	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.	Change from baseline to two weeks after the surgery
Secondary	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.	Change from baseline to two weeks after the surgery

External Links

•   hort-term effects of cervical kinesio taping on pain and cervical range of motion in patients with acute whiplash injury: a randomized clinical trial.
•   Low Back Pain