KT® in Patients With Cervical Spine Surgery

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04039581
Collaborator
Bahçeşehir University (Other)
90
1
3
14.4
6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Kinesio Taping
  • Other: Transcutaneous Electrical Nerve Stimulation (TENS)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Short-Term Effects of Kinesio Taping® on Pain and Functionality in Patients With Cervical Spine Surgery
Actual Study Start Date :
Oct 19, 2019
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group Kinesio Taping and TENS

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 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. In the conventional treatment TENS (Transcutaneous electrical nerve stimulation) applications and therapeutic exercises on the painful area, every day and 2 channels with 4 electrodes in the acute period (first 72 hours) will be applied. The conventional therapy method will also include therapeutic exercises.

Other: Kinesio Taping
Kinesio Taping

Other: Transcutaneous Electrical Nerve Stimulation (TENS)
TENS

Active Comparator: Group TENS

The number of participants in this group are anticipated to be 30. This group will be receiving only conventional treatment. In the conventional treatment TENS (Transcutaneous electrical nerve stimulation) applications and therapeutic exercises on the painful area every day and 2 channels with 4 electrodes in the acute period (first 72 hours) will be applied. The conventional therapy method will also include therapeutic exercises. These exercises will be taught to participants from the first treatment session and will be performed under the supervision of a physiotherapist. Therapeutic exercises will consist of active shoulder evolution, active cervical rotations, active cervical lateral flexion movement and active shoulder flexion and abduction exercises.

Other: Transcutaneous Electrical Nerve Stimulation (TENS)
TENS

Active Comparator: Group 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.

Other: Kinesio Taping
Kinesio Taping

Outcome Measures

Primary Outcome Measures

  1. Neck Pain Score [Change from baseline to two weeks after the surgery]

    Pain 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.

  2. Health Related Quality of Life Score [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.

  3. Disability Score [Change from baseline to two weeks after the surgery]

    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.

  4. Range of Motion Value (degree) [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.

  5. Functionality Score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

  • Plaque screw, tilif, intramedullary nails have been used in the spine,

  • Individuals with any congenital deformity in the spine,

  • Having any rheumatologic, neurological and orthopedic disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bahçeşehir University İstanbul Turkey

Sponsors and Collaborators

  • Marmara University
  • Bahçeşehir University

Investigators

  • Study Director: Tuğba KURU ÇOLAK, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Marmara University
ClinicalTrials.gov Identifier:
NCT04039581
Other Study ID Numbers:
  • Marmara University
First Posted:
Jul 31, 2019
Last Update Posted:
Feb 24, 2021
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2021