Trial Outcomes & Findings for Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain (NCT NCT03895307)
NCT ID: NCT03895307
Last Updated: 2021-04-13
Results Overview
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
COMPLETED
NA
84 participants
day 0 (before intervention)
2021-04-13
Participant Flow
Participant milestones
| Measure |
Kinesio Taping
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
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
|
Local Anesthetic
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
22
|
21
|
|
Overall Study
COMPLETED
|
19
|
20
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Kinesio Taping
n=21 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Local Anesthetic
n=22 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
74 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
Age, Continuous
|
39.67 years
STANDARD_DEVIATION 15.72 • n=39 Participants
|
47.20 years
STANDARD_DEVIATION 16.60 • n=41 Participants
|
47.82 years
STANDARD_DEVIATION 15.95 • n=35 Participants
|
41.48 years
STANDARD_DEVIATION 15.69 • n=31 Participants
|
44.05 years
STANDARD_DEVIATION 16.09 • n=146 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
12 Participants
n=31 Participants
|
34 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
50 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
84 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
Turkey
|
21 participants
n=39 Participants
|
20 participants
n=41 Participants
|
22 participants
n=35 Participants
|
21 participants
n=31 Participants
|
84 participants
n=146 Participants
|
|
Body Mass Index
|
27.63 kg/m2
STANDARD_DEVIATION 4.70 • n=39 Participants
|
27.25 kg/m2
STANDARD_DEVIATION 3.88 • n=41 Participants
|
27.05 kg/m2
STANDARD_DEVIATION 4.47 • n=35 Participants
|
27.05 kg/m2
STANDARD_DEVIATION 3.73 • n=31 Participants
|
27.24 kg/m2
STANDARD_DEVIATION 4.13 • n=146 Participants
|
PRIMARY outcome
Timeframe: day 0 (before intervention)Population: intent to treat population(all participants)
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Outcome measures
| Measure |
Local Anesthetic
n=22 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=21 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Pain Severity: Visual Analog Scale
|
7.8 score on a scale
Standard Deviation 0.89
|
7.62 score on a scale
Standard Deviation 0.92
|
7.75 score on a scale
Standard Deviation 0.44
|
7.26 score on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: day 16 (after 6th application)Population: intent to treat population(all participants)
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Pain Severity: Visual Analog Scale
|
2.85 score on a scale
Standard Deviation 1.98
|
3.52 score on a scale
Standard Deviation 2.13
|
3.35 score on a scale
Standard Deviation 2.11
|
2.89 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 1 month after interventionPopulation: intent to treat population(all participants)
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Pain Severity: Visual Analog Scale
|
3.65 score on a scale
Standard Deviation 2.36
|
5.81 score on a scale
Standard Deviation 2.18
|
4.65 score on a scale
Standard Deviation 2.99
|
3.58 score on a scale
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: 3 months after interventionPopulation: intent to treat population(all participants)
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Pain Severity: Visual Analog Scale
|
5 score on a scale
Standard Deviation 2.77
|
6.48 score on a scale
Standard Deviation 2.22
|
5.20 score on a scale
Standard Deviation 2.94
|
4.42 score on a scale
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: day 0 (before intervention)Population: intent to treat population(all participants)
Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Outcome measures
| Measure |
Local Anesthetic
n=22 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=21 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Disability Severity: Oswestry Disabiliy Index
|
17.1 score on a scale
Standard Deviation 2.38
|
17.57 score on a scale
Standard Deviation 1.72
|
18.30 score on a scale
Standard Deviation 3.45
|
17.42 score on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: day 16 (after 6th application)Population: intent to treat population(all participants)
Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Disability Severity: Oswestry Disability Index
|
6.15 score on a scale
Standard Deviation 4.95
|
10.43 score on a scale
Standard Deviation 5.07
|
6.50 score on a scale
Standard Deviation 6.66
|
7.68 score on a scale
Standard Deviation 6.67
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: intent to treat population(all participants)
Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Disability Severity: Oswestry Disability Index
|
8.85 score on a scale
Standard Deviation 6.67
|
14.38 score on a scale
Standard Deviation 4.57
|
10.50 score on a scale
Standard Deviation 7.58
|
10.84 score on a scale
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: 3 months after interventionPopulation: intent to treat population(all participants)
Oswestry Disabiliy Index: minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Disability Severity: Oswestry Disability Index
|
13.35 score on a scale
Standard Deviation 4.35
|
16.10 score on a scale
Standard Deviation 3.89
|
14.20 score on a scale
Standard Deviation 6.52
|
13.84 score on a scale
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: day 0 (before intervention)Population: intent to treat population(all participants)
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
Outcome measures
| Measure |
Local Anesthetic
n=22 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=21 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form 36 Physical Functioning
|
45.9 score on a scale
Standard Deviation 12.54
|
50.71 score on a scale
Standard Deviation 12.97
|
50.75 score on a scale
Standard Deviation 14.53
|
53.1 score on a scale
Standard Deviation 13.08
|
SECONDARY outcome
Timeframe: day 16 (after 6th application)Population: intent to treat population(all participants)
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
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form 36 Physical Functioning
|
75 score on a scale
Standard Deviation 15.39
|
74.05 score on a scale
Standard Deviation 15.46
|
74 score on a scale
Standard Deviation 13.53
|
77.63 score on a scale
Standard Deviation 14.75
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: intent to treat population(all participants)
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
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form 36 Physical Functioning
|
67.20 score on a scale
Standard Deviation 16.26
|
57.86 score on a scale
Standard Deviation 16.32
|
61.70 score on a scale
Standard Deviation 19.47
|
68.11 score on a scale
Standard Deviation 16.69
|
SECONDARY outcome
Timeframe: 3 months after interventionPopulation: intent to treat population(all participants)
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
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form 36 Physical Functioning
|
56.65 score on a scale
Standard Deviation 16.27
|
54.05 score on a scale
Standard Deviation 14.63
|
55.15 score on a scale
Standard Deviation 15.35
|
58.84 score on a scale
Standard Deviation 13.26
|
SECONDARY outcome
Timeframe: day 0 (before intervention)Population: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=22 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=21 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Spinal Mobility: Schober Test
|
3.75 centimeters
Standard Deviation 0.88
|
4.38 centimeters
Standard Deviation 0.72
|
4.37 centimeters
Standard Deviation 0.77
|
4.09 centimeters
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: day 16 (after 6th application)Population: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Spinal Mobility: Schober Test
|
4.27 centimeters
Standard Deviation 0.63
|
4.59 centimeters
Standard Deviation 0.49
|
4.37 centimeters
Standard Deviation 0.77
|
4.36 centimeters
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Spinal Mobility: Schober Test
|
4.27 centimeters
Standard Deviation 0.63
|
4.54 centimeters
Standard Deviation 0.54
|
4.42 centimeters
Standard Deviation 0.74
|
4.36 centimeters
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 3 months after interventionPopulation: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Spinal Mobility: Schober Test
|
4.2 centimeters
Standard Deviation 0.61
|
4.54 centimeters
Standard Deviation 0.54
|
4.42 centimeters
Standard Deviation 0.74
|
4.36 centimeters
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: day 0 before interventionPopulation: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=22 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=21 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form-36 Mental Health
|
68 score on a scale
Standard Deviation 0
|
68 score on a scale
Standard Deviation 0
|
67.5 score on a scale
Standard Deviation 2.23
|
68 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: day 16 (after 6th application)Population: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form-36 Mental Health
|
78 score on a scale
Standard Deviation 5.51
|
77.52 score on a scale
Standard Deviation 2.18
|
78.6 score on a scale
Standard Deviation 5.51
|
79.79 score on a scale
Standard Deviation 7.48
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form-36 Mental Health
|
76.6 score on a scale
Standard Deviation 7.05
|
71.81 score on a scale
Standard Deviation 4.97
|
73.10 score on a scale
Standard Deviation 7.96
|
77.16 score on a scale
Standard Deviation 9.29
|
SECONDARY outcome
Timeframe: 3 months after interventionPopulation: intent to treat population(all participants)
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.
Outcome measures
| Measure |
Local Anesthetic
n=20 Participants
18-20 cc %0.5 lidocaine subcutaneous injection
local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
|
Local Serum Physiologic
n=21 Participants
18-20 cc % 0.09 NaCl subcutaneous injection
local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
|
Sham Kinesio Taping
n=20 Participants
two 15 cm I type kinesio tape applied longitudinally but without stretching
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
Kinesio Taping
n=19 Participants
two 15 cm I type kinesio tape applied longitudinally
kinesio tape: two 15 cm I type kinesio tape applied longitudinally
|
|---|---|---|---|---|
|
Patient Reported Quality of Life: Short Form-36 Mental Health
|
73.60 score on a scale
Standard Deviation 7.93
|
71.33 score on a scale
Standard Deviation 4.83
|
72.1 score on a scale
Standard Deviation 7.90
|
74.42 score on a scale
Standard Deviation 7.96
|
Adverse Events
Kinesio Tape
Sham Kinesio Taping
Local Anesthetic
Local Serum Physiologic
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place