Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
kinesio tape
local anesthetic
local serum physiologic
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic low back pain, kinesio taping, injection, local anesthetic
Eligibility Criteria
Inclusion Criteria:
- Under 18 years of age under 75 years
- Chronic mechanic (decreased with resting and resting) for at least 3 months
- Visual Analogue Scale score of at least 60-
Exclusion Criteria:
- Having mental problems
- Having the disease affecting the peripheral and central nervous system
- Have received physical therapy in the lumbar region within the last 3 months
- Injection into the lumbar region within the last 3 months
- Having a history of waist region surgery
- Low motor dysfunction in lower extremity in physical examination
- Needle phobia
- Is allergic to lidocaine
- Kinesio tape allergy
- Wound, infection, burn, allergic lesions in the application area
Sites / Locations
- Sultan 2.Abdülhamid Han Training and Research Hospital
- Sultan Abdülhamid Han Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
kinesio taping
sham kinesio taping
local anesthetic
local serum physiologic
Arm Description
two 15 cm I type kinesio tape applied longitudinally
two 15 cm I type kinesio tape applied longitudinally but without stretching
18-20 cc %0.5 lidocaine subcutaneous injection
18-20 cc % 0.09 NaCl subcutaneous injection
Outcomes
Primary Outcome Measures
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Secondary Outcome Measures
Disability Severity: Oswestry Disabiliy Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Disability Severity: Oswestry Disability Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Disability Severity: Oswestry Disability Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Disability Severity: Oswestry Disability Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Patient Reported Quality of Life: Short Form 36 Physical Functioning
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Patient Reported Quality of Life: Short Form 36 Physical Functioning
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Patient Reported Quality of Life: Short Form 36 Physical Functioning
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Patient Reported Quality of Life: Short Form 36 Physical Functioning
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Spinal Mobility: Schober Test
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Spinal Mobility: Schober Test
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Spinal Mobility: Schober Test
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Spinal Mobility: Schober Test
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Patient Reported Quality of Life: Short Form-36 Mental Health
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Patient Reported Quality of Life: Short Form-36 Mental Health
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Patient Reported Quality of Life: Short Form-36 Mental Health
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Patient Reported Quality of Life: Short Form-36 Mental Health
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Full Information
NCT ID
NCT03895307
First Posted
March 28, 2019
Last Updated
March 20, 2021
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT03895307
Brief Title
Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
Official Title
Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low back pain can be seen in every period of life. More than 80 percent of the society complain of low back pain at any time of life. Although the frequency of applying to a health institution due to low back pain varies from one society to the other, it takes place in the first three places in each community. Low back pain should be differentiated as new (acute) and long-term (chronic). In the treatment of chronic low back pain, rest, education, pharmacological treatment, physical therapy, painful point injections, surgical interventions, kinesio taping can be applied. The most frequently used physical therapy modalities for treatment of chronic low back pain are superficial and deep heat modalities (hot pack, infrared, ultrasound, microwave diathermy radar) and analgesic effective electrotherapy (TENS, interferential flows) modalities. One of the most important treatments is exercise therapy. In cases where conventional treatment of chronic low back pain is insufficient, that is, the patient's pain is still ongoing and functional recovery is insufficient, some alternative methods are also applied. These treatments include ozone, prolotherapy injection applications, dry needling, acupuncture, phytotherapy, balneotherapy, kinesio taping and so on. The aim of this study is to compare the efficacy of painful point injection and kinesio taping treatments in lumbar region in patients with chronic low back pain.
Detailed Description
Approximately 84 volunteer patients will be included in the study, patients older than 18 years, under 75 years of age, with a minimum of 3 months of mechanical back pain, Visual Analog Scale score of at least 60 patients will be included. Who are older than 18 years of age, having mental problems, having peripheral problems affecting the central nervous system, having received physical therapy to the lumbar region in the last 3 months, having been applied to the lumbar region within the last 3 months, having a history of lumbar region surgery, having a history of patients with motor deficit in the extremity, needle phobia, lidocaine and / or kinesio tape allergy, patients with wound, infection, burn, allergic lesions in the application area will not be included.
Patients included in the study will be included in the first (first), second (second), third (third) or fourth (fourth) treatment group by random number generator method.
The first group will be given the hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16. days.
The second group will be given a hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16 days.
The third group hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16. days, kinesio tape will be applied to the determined areas.
the fourth group hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16. days sham tape application will be made in the regions determined. ****
Patients in all groups will continue to use the hotpack and exercises until the 3rd month after the first day of their study. First session exercises with the same physiotherapist (stretching for back-waist, iliopsoas and hamstring muscles; exercise range of hip and waist; hip and waist isometric exercises). Each patient will do the exercises 20 minutes after the hot package application.
saline and local anesthetic injection points to be applied to the lumbar region:
Future points on spinous projections from L1 to L5
Lumbar region 2 from the middle point of the spinous output bilateral and 2 cm to 4 cm lateral points
To each point of the iliac lobe of iliac crest will be injected subcutaneously with 0.5 ml 0.5% lidocaine-containing local anesthetic.
6 mm 30 gauge needle tip will be used for injection.
For each patient who underwent subcutaneous local anesthetic, an average of 18-20 ml of 0.5% lidocaine-containing local anesthetic and 18-20 ml of 0.09% NaCl-containing isotonic saline will be used for each patient.
These points are the points of quadle technique applied in neural therapy.
Kinesio taping will use 2 cut-to-length I-bands with a length of about 15 cm long for one patient. Space correction technique will be used for patients. The lumbar region of the patients will be glued vertically to the paravertebral muscles vertically 3-4 cm lateral to the spinous projections. As a starting point for patients, S1 will be adhered to the vertebra without tension, then the patient will be asked to come with maximum lumbar flexion posterior.
For a patient in the treatment of sham kinesio taping, 2 pieces of approximately 15 cm long ends will be used to cut the curved I bands. The lumbar region of the patients will be glued vertically to the paravertebral muscles vertically 3-4 cm lateral to the spinous projections. Patients in the upright posture, kinesio tape S1 applied from the vertebra without stretching will be glued upwards and taped upwards.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
chronic low back pain, kinesio taping, injection, local anesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
kinesio taping
Arm Type
Experimental
Arm Description
two 15 cm I type kinesio tape applied longitudinally
Arm Title
sham kinesio taping
Arm Type
Placebo Comparator
Arm Description
two 15 cm I type kinesio tape applied longitudinally but without stretching
Arm Title
local anesthetic
Arm Type
Experimental
Arm Description
18-20 cc %0.5 lidocaine subcutaneous injection
Arm Title
local serum physiologic
Arm Type
Placebo Comparator
Arm Description
18-20 cc % 0.09 NaCl subcutaneous injection
Intervention Type
Other
Intervention Name(s)
kinesio tape
Intervention Description
two 15 cm I type kinesio tape applied longitudinally
Intervention Type
Other
Intervention Name(s)
local anesthetic
Intervention Description
local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
Intervention Type
Other
Intervention Name(s)
local serum physiologic
Intervention Description
serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Primary Outcome Measure Information:
Title
Pain Severity: Visual Analog Scale
Description
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame
day 0 (before intervention)
Title
Pain Severity: Visual Analog Scale
Description
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame
day 16 (after 6th application)
Title
Pain Severity: Visual Analog Scale
Description
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame
1 month after intervention
Title
Pain Severity: Visual Analog Scale
Description
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
Disability Severity: Oswestry Disabiliy Index
Description
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Time Frame
day 0 (before intervention)
Title
Disability Severity: Oswestry Disability Index
Description
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Time Frame
day 16 (after 6th application)
Title
Disability Severity: Oswestry Disability Index
Description
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Time Frame
1 month after intervention
Title
Disability Severity: Oswestry Disability Index
Description
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Time Frame
3 months after intervention
Title
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Description
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Time Frame
day 0 (before intervention)
Title
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Description
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Time Frame
day 16 (after 6th application)
Title
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Description
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Time Frame
1 month after intervention
Title
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Description
short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life
Time Frame
3 months after intervention
Title
Spinal Mobility: Schober Test
Description
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Time Frame
day 0 (before intervention)
Title
Spinal Mobility: Schober Test
Description
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Time Frame
day 16 (after 6th application)
Title
Spinal Mobility: Schober Test
Description
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Time Frame
1 month after intervention
Title
Spinal Mobility: Schober Test
Description
Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).
Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.
A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.
The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.
Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.
Time Frame
3 months after intervention
Title
Patient Reported Quality of Life: Short Form-36 Mental Health
Description
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Time Frame
day 0 before intervention
Title
Patient Reported Quality of Life: Short Form-36 Mental Health
Description
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Time Frame
day 16 (after 6th application)
Title
Patient Reported Quality of Life: Short Form-36 Mental Health
Description
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Time Frame
1 month after intervention
Title
Patient Reported Quality of Life: Short Form-36 Mental Health
Description
Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.
Time Frame
3 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Under 18 years of age under 75 years
Chronic mechanic (decreased with resting and resting) for at least 3 months
Visual Analogue Scale score of at least 60-
Exclusion Criteria:
Having mental problems
Having the disease affecting the peripheral and central nervous system
Have received physical therapy in the lumbar region within the last 3 months
Injection into the lumbar region within the last 3 months
Having a history of waist region surgery
Low motor dysfunction in lower extremity in physical examination
Needle phobia
Is allergic to lidocaine
Kinesio tape allergy
Wound, infection, burn, allergic lesions in the application area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADEM ERBİROL
Organizational Affiliation
sultan abdulhamid han
Official's Role
Study Director
Facility Information:
Facility Name
Sultan 2.Abdülhamid Han Training and Research Hospital
City
Istanbul
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
34000
Country
Turkey
Facility Name
Sultan Abdülhamid Han Training and Research Hospital
City
Istanbul
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
other researchers would get information from the main researcher. therefore it was not shared.
Learn more about this trial
Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
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