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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03895307

Enrollment

Registered

2019-03-29

Start date

2019-04-01

Completion date

2019-08-01

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain, kinesio taping, injection, local anesthetic

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: 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.

Interventions

OTHERkinesio tape

two 15 cm I type kinesio tape applied longitudinally

OTHERlocal anesthetic

local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection

OTHERlocal serum physiologic

serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Severity: Visual Analog Scale	day 0 (before intervention)	visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

Secondary

Measure	Time frame	Description
Disability Severity: Oswestry Disabiliy Index	day 0 (before intervention)	Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Disability Severity: Oswestry Disability Index	day 16 (after 6th application)	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	day 0 (before intervention)	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	day 0 (before intervention)	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	day 0 before intervention	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.

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

Arm	Count
Kinesio Taping two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	21
Sham Kinesio Taping two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	20
Local Anesthetic 18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	22
Local Serum Physiologic 18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection	21
Total	84

Baseline characteristics

Characteristic	Local Serum Physiologic	Local Anesthetic	Sham Kinesio Taping	Kinesio Taping	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	5 Participants	3 Participants	1 Participants	10 Participants
Age, Categorical Between 18 and 65 years	20 Participants	17 Participants	17 Participants	20 Participants	74 Participants
Age, Continuous	41.48 years STANDARD_DEVIATION 15.69	47.82 years STANDARD_DEVIATION 15.95	47.20 years STANDARD_DEVIATION 16.6	39.67 years STANDARD_DEVIATION 15.72	44.05 years STANDARD_DEVIATION 16.09
Body Mass Index	27.05 kg/m2 STANDARD_DEVIATION 3.73	27.05 kg/m2 STANDARD_DEVIATION 4.47	27.25 kg/m2 STANDARD_DEVIATION 3.88	27.63 kg/m2 STANDARD_DEVIATION 4.7	27.24 kg/m2 STANDARD_DEVIATION 4.13
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	21 Participants	22 Participants	20 Participants	21 Participants	84 Participants
Region of Enrollment Turkey	21 participants	22 participants	20 participants	21 participants	84 participants
Sex: Female, Male Female	12 Participants	5 Participants	8 Participants	9 Participants	34 Participants
Sex: Female, Male Male	9 Participants	17 Participants	12 Participants	12 Participants	50 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary