Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895307
• Other study ID #: ademerbirol
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2021
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Future points on spinous projections from L1 to L5

2. Lumbar region 2 from the middle point of the spinous output bilateral and 2 cm to 4 cm lateral points

3. To each point of the iliac lobe of iliac crest will be injected subcutaneously with 0.5 ml 0.5% lidocaine-containing local anesthetic.

4. 6 mm 30 gauge needle tip will be used for injection.

5. 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.

6. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Under 18 years of age under 75 years

2. Chronic mechanic (decreased with resting and resting) for at least 3 months

3. Visual Analogue Scale score of at least 60-

Exclusion Criteria:

1. Having mental problems

2. Having the disease affecting the peripheral and central nervous system

3. Have received physical therapy in the lumbar region within the last 3 months

4. Injection into the lumbar region within the last 3 months

5. Having a history of waist region surgery

6. Low motor dysfunction in lower extremity in physical examination

7. Needle phobia

8. Is allergic to lidocaine

9. Kinesio tape allergy

10. Wound, infection, burn, allergic lesions in the application area

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• kinesio tape
two 15 cm I type kinesio tape applied longitudinally
• local anesthetic
local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
• local serum physiologic
serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection

Locations

Country	Name	City	State
Turkey	Sultan 2.Abdülhamid Han Training and Research Hospital	Istanbul	Eyalet/Yerleske
Turkey	Sultan Abdülhamid Han Training and Research Hospital	Istanbul	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity: Visual Analog Scale	visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain	day 0 (before intervention)
Primary	Pain Severity: Visual Analog Scale	visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain	day 16 (after 6th application)
Primary	Pain Severity: Visual Analog Scale	visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain	1 month after intervention
Primary	Pain Severity: Visual Analog Scale	visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain	3 months after intervention
Secondary	Disability Severity: Oswestry Disabiliy Index	Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability	day 0 (before intervention)
Secondary	Disability Severity: Oswestry Disability Index	Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability	day 16 (after 6th application)
Secondary	Disability Severity: Oswestry Disability Index	Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability	1 month after intervention
Secondary	Disability Severity: Oswestry Disability Index	Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability	3 months after intervention
Secondary	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	day 0 (before intervention)
Secondary	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	day 16 (after 6th application)
Secondary	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	1 month after intervention
Secondary	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	3 months after intervention
Secondary	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.	day 0 (before intervention)
Secondary	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.	day 16 (after 6th application)
Secondary	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.	1 month after intervention
Secondary	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.	3 months after intervention
Secondary	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.	day 0 before intervention
Secondary	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.	day 16 (after 6th application)
Secondary	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.	1 month after intervention
Secondary	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.	3 months after intervention