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

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
• Overall Status: Completed
• CT.gov ID: NCT03895307
• Collaborator: (none)
• Enrollment: 84
• Locations: 2
• Arms: 4
• Actual Duration (Months): 4
• Patients Per Site: 42
• Patients Per Site Per Month: 10.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Other: kinesio tape; Other: local anesthetic; Other: local serum physiologic	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: kinesio taping two 15 cm I type kinesio tape applied longitudinally	Other: kinesio tape; two 15 cm I type kinesio tape applied longitudinally
Placebo Comparator: sham kinesio taping two 15 cm I type kinesio tape applied longitudinally but without stretching	Other: kinesio tape; two 15 cm I type kinesio tape applied longitudinally
Experimental: local anesthetic 18-20 cc %0.5 lidocaine subcutaneous injection	Other: local anesthetic; local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
Placebo Comparator: local serum physiologic 18-20 cc % 0.09 NaCl subcutaneous injection	Other: local serum physiologic; serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Pain Severity: Visual Analog Scale [day 0 (before intervention)]

   visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

2. Pain Severity: Visual Analog Scale [day 16 (after 6th application)]

   visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

3. Pain Severity: Visual Analog Scale [1 month after intervention]

   visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

4. Pain Severity: Visual Analog Scale [3 months after intervention]

   visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

Secondary Outcome Measures

1. Disability Severity: Oswestry Disabiliy Index [day 0 (before intervention)]

   Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability

2. 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

3. Disability Severity: Oswestry Disability Index [1 month after intervention]

   Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability

4. Disability Severity: Oswestry Disability Index [3 months after intervention]

   Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability

5. 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

6. Patient Reported Quality of Life: Short Form 36 Physical Functioning [day 16 (after 6th application)]

   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

7. Patient Reported Quality of Life: Short Form 36 Physical Functioning [1 month after 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

8. Patient Reported Quality of Life: Short Form 36 Physical Functioning [3 months after 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

9. 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.

10. Spinal Mobility: Schober Test [day 16 (after 6th application)]

    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.

11. Spinal Mobility: Schober Test [1 month after 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.

12. Spinal Mobility: Schober Test [3 months after 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.

13. 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.

14. Patient Reported Quality of Life: Short Form-36 Mental Health [day 16 (after 6th application)]

    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.

15. Patient Reported Quality of Life: Short Form-36 Mental Health [1 month after 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.

16. Patient Reported Quality of Life: Short Form-36 Mental Health [3 months after 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sultan 2.Abdülhamid Han Training and Research Hospital	Istanbul	Eyalet/Yerleşke	Turkey	34000
2	Sultan Abdülhamid Han Training and Research Hospital	Istanbul	Eyalet/Yerleşke	Turkey	34000

Sponsors and Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

• Study Director: ADEM ERBİROL, sultan abdulhamid han

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2019

More Information

Publications

None provided.

• Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• ClinicalTrials.gov Identifier: NCT03895307
• Other Study ID Numbers: ademerbirol
• First Posted: Mar 29, 2019
• Last Update Posted: Apr 13, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: chronic low back pain; kinesio taping; injection; local anesthetic
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Anesthetics; Anesthetics, Local

Study Results

Participant Flow

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Period Title: Overall Study
STARTED	21	20	22	21
COMPLETED	19	20	20	21
NOT COMPLETED	2	0	2	0

Baseline Characteristics

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic	Total
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection	Total of all reporting groups
Overall Participants	21	20	22	21	84
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	20 95.2%	17 85%	17 77.3%	20 95.2%	74 88.1%
>=65 years	1 4.8%	3 15%	5 22.7%	1 4.8%	10 11.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.67 (15.72)	47.20 (16.60)	47.82 (15.95)	41.48 (15.69)	44.05 (16.09)
Sex: Female, Male (Count of Participants)
Female	9 42.9%	8 40%	5 22.7%	12 57.1%	34 40.5%
Male	12 57.1%	12 60%	17 77.3%	9 42.9%	50 59.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	21 100%	20 100%	22 100%	21 100%	84 100%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Turkey	21 100%	20 100%	22 100%	21 100%	84 100%
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	27.63 (4.70)	27.25 (3.88)	27.05 (4.47)	27.05 (3.73)	27.24 (4.13)

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	21	20	22	21
Mean (Standard Deviation) [score on a scale]	7.26 (0.8)	7.75 (0.44)	7.8 (0.89)	7.62 (0.92)

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	2.89 (2.1)	3.35 (2.11)	2.85 (1.98)	3.52 (2.13)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	3.58 (2.56)	4.65 (2.99)	3.65 (2.36)	5.81 (2.18)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	4.42 (2.41)	5.20 (2.94)	5 (2.77)	6.48 (2.22)

5. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	21	20	22	21
Mean (Standard Deviation) [score on a scale]	17.42 (2.65)	18.30 (3.45)	17.1 (2.38)	17.57 (1.72)

6. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	7.68 (6.67)	6.50 (6.66)	6.15 (4.95)	10.43 (5.07)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	10.84 (8.21)	10.50 (7.58)	8.85 (6.67)	14.38 (4.57)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	13.84 (6.44)	14.20 (6.52)	13.35 (4.35)	16.10 (3.89)

9. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	21	20	22	21
Mean (Standard Deviation) [score on a scale]	53.1 (13.08)	50.75 (14.53)	45.9 (12.54)	50.71 (12.97)

10. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	77.63 (14.75)	74 (13.53)	75 (15.39)	74.05 (15.46)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	68.11 (16.69)	61.70 (19.47)	67.20 (16.26)	57.86 (16.32)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	58.84 (13.26)	55.15 (15.35)	56.65 (16.27)	54.05 (14.63)

13. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	21	20	22	21
Mean (Standard Deviation) [centimeters]	4.09 (0.58)	4.37 (0.77)	3.75 (0.88)	4.38 (0.72)

14. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [centimeters]	4.36 (0.43)	4.37 (0.77)	4.27 (0.63)	4.59 (0.49)

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [centimeters]	4.36 (0.43)	4.42 (0.74)	4.27 (0.63)	4.54 (0.54)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [centimeters]	4.36 (0.43)	4.42 (0.74)	4.2 (0.61)	4.54 (0.54)

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	21	20	22	21
Mean (Standard Deviation) [score on a scale]	68 (0)	67.5 (2.23)	68 (0)	68 (0)

18. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	79.79 (7.48)	78.6 (5.51)	78 (5.51)	77.52 (2.18)

19. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	77.16 (9.29)	73.10 (7.96)	76.6 (7.05)	71.81 (4.97)

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Kinesio Taping	Sham Kinesio Taping	Local Anesthetic	Local Serum Physiologic
Arm/Group Description	two 15 cm I type kinesio tape applied longitudinally kinesio tape: two 15 cm I type kinesio tape applied longitudinally	two 15 cm I type kinesio tape applied longitudinally but without stretching kinesio tape: two 15 cm I type kinesio tape applied longitudinally	18-20 cc %0.5 lidocaine subcutaneous injection local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection	18-20 cc % 0.09 NaCl subcutaneous injection local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
Measure Participants	19	20	20	21
Mean (Standard Deviation) [score on a scale]	74.42 (7.96)	72.1 (7.90)	73.60 (7.93)	71.33 (4.83)

Adverse Events

Time Frame	adverse events were not monitored/assessed
Adverse Event Reporting Description	adverse events were not monitored/assessed
Arm/Group Title	Kinesio Tape		Sham Kinesio Taping		Local Anesthetic		Local Serum Physiologic
Arm/Group 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
All Cause Mortality
	Kinesio Tape		Sham Kinesio Taping		Local Anesthetic		Local Serum Physiologic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Kinesio Tape		Sham Kinesio Taping		Local Anesthetic		Local Serum Physiologic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Kinesio Tape		Sham Kinesio Taping		Local Anesthetic		Local Serum Physiologic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.