KT® in Patients With Cervical Spine Surgery

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Kinesio Taping

Transcutaneous Electrical Nerve Stimulation (TENS)

About this trial

This is an interventional health services research trial for Pain focused on measuring Kinesio Tape, Pain, Functionality, Cervical Spine Surgery

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bahçeşehir University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group Kinesio Taping and TENS

Group TENS

Group Kinesio Taping

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Neck Pain Score

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.

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.

Disability Score

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.

Range of Motion Value (degree)

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04039581

First Posted

July 24, 2019

Last Updated

October 5, 2023

Sponsor

Marmara University

Collaborators

Bahçeşehir University

1. Study Identification

Unique Protocol Identification Number

NCT04039581

Brief Title

KT® in Patients With Cervical Spine Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

October 19, 2019 (Actual)

Primary Completion Date

December 30, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Marmara University

Collaborators

Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Cervical Spinal Stenosis, Disc, Herniated, Cervical Spondylosis

Keywords

Kinesio Tape, Pain, Functionality, Cervical Spine Surgery

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group Kinesio Taping and TENS

Arm Type

Experimental

Arm Description

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.

Arm Title

Group TENS

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group Kinesio Taping

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Kinesio Taping

Intervention Description

Kinesio Taping

Intervention Type

Other

Intervention Name(s)

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Description

TENS

Primary Outcome Measure Information:

Title

Neck Pain Score

Description

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.

Time Frame