Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

KT® in Patients With Cervical Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039581
Recruitment Status : Active, not recruiting
First Posted : July 31, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Bahçeşehir University
Information provided by (Responsible Party):
Marmara University

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
Pain Cervical Spinal Stenosis Disc, Herniated Cervical Spondylosis Other: Kinesio Taping Other: Transcutaneous Electrical Nerve Stimulation (TENS) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 19, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Neck Pain Score [ Time Frame: 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 [ 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.

  3. Disability Score [ Time Frame: 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) [ 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039581


Locations
Layout table for location information
Turkey
Bahçeşehir University
İstanbul, Turkey
Sponsors and Collaborators
Marmara University
Bahçeşehir University
Investigators
Layout table for investigator information
Study Director: Tuğba KURU ÇOLAK Marmara University
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT04039581    
Other Study ID Numbers: Marmara University
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
Kinesio Tape
Pain
Functionality
Cervical Spine Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Stenosis
Spondylosis
Intervertebral Disc Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical