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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

day 0 (before intervention)

Results posted on

2021-04-13

Participant Flow

Participant milestones

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

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=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
17 Participants
n=7 Participants
17 Participants
n=5 Participants
20 Participants
n=4 Participants
74 Participants
n=21 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
1 Participants
n=4 Participants
10 Participants
n=21 Participants
Age, Continuous
39.67 years
STANDARD_DEVIATION 15.72 • n=5 Participants
47.20 years
STANDARD_DEVIATION 16.60 • n=7 Participants
47.82 years
STANDARD_DEVIATION 15.95 • n=5 Participants
41.48 years
STANDARD_DEVIATION 15.69 • n=4 Participants
44.05 years
STANDARD_DEVIATION 16.09 • n=21 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
8 Participants
n=7 Participants
5 Participants
n=5 Participants
12 Participants
n=4 Participants
34 Participants
n=21 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
12 Participants
n=7 Participants
17 Participants
n=5 Participants
9 Participants
n=4 Participants
50 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
White
21 Participants
n=5 Participants
20 Participants
n=7 Participants
22 Participants
n=5 Participants
21 Participants
n=4 Participants
84 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Region of Enrollment
Turkey
21 participants
n=5 Participants
20 participants
n=7 Participants
22 participants
n=5 Participants
21 participants
n=4 Participants
84 participants
n=21 Participants
Body Mass Index
27.63 kg/m2
STANDARD_DEVIATION 4.70 • n=5 Participants
27.25 kg/m2
STANDARD_DEVIATION 3.88 • n=7 Participants
27.05 kg/m2
STANDARD_DEVIATION 4.47 • n=5 Participants
27.05 kg/m2
STANDARD_DEVIATION 3.73 • n=4 Participants
27.24 kg/m2
STANDARD_DEVIATION 4.13 • n=21 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

Outcome measures
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
Pain Severity: Visual Analog Scale
7.26 score on a scale
Standard Deviation 0.8
7.75 score on a scale
Standard Deviation 0.44
7.8 score on a scale
Standard Deviation 0.89
7.62 score on a scale
Standard Deviation 0.92

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

Outcome measures
Measure
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
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=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
Pain Severity: Visual Analog Scale
2.89 score on a scale
Standard Deviation 2.1
3.35 score on a scale
Standard Deviation 2.11
2.85 score on a scale
Standard Deviation 1.98
3.52 score on a scale
Standard Deviation 2.13

PRIMARY outcome

Timeframe: 1 month after 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

Outcome measures
Measure
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
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=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
Pain Severity: Visual Analog Scale
3.58 score on a scale
Standard Deviation 2.56
4.65 score on a scale
Standard Deviation 2.99
3.65 score on a scale
Standard Deviation 2.36
5.81 score on a scale
Standard Deviation 2.18

PRIMARY outcome

Timeframe: 3 months after 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

Outcome measures
Measure
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
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=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
Pain Severity: Visual Analog Scale
4.42 score on a scale
Standard Deviation 2.41
5.20 score on a scale
Standard Deviation 2.94
5 score on a scale
Standard Deviation 2.77
6.48 score on a scale
Standard Deviation 2.22

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

Outcome measures
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
Disability Severity: Oswestry Disabiliy Index
17.42 score on a scale
Standard Deviation 2.65
18.30 score on a scale
Standard Deviation 3.45
17.1 score on a scale
Standard Deviation 2.38
17.57 score on a scale
Standard Deviation 1.72

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

Outcome measures
Measure
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
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=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
Disability Severity: Oswestry Disability Index
7.68 score on a scale
Standard Deviation 6.67
6.50 score on a scale
Standard Deviation 6.66
6.15 score on a scale
Standard Deviation 4.95
10.43 score on a scale
Standard Deviation 5.07

SECONDARY outcome

Timeframe: 1 month after 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

Outcome measures
Measure
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
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=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
Disability Severity: Oswestry Disability Index
10.84 score on a scale
Standard Deviation 8.21
10.50 score on a scale
Standard Deviation 7.58
8.85 score on a scale
Standard Deviation 6.67
14.38 score on a scale
Standard Deviation 4.57

SECONDARY outcome

Timeframe: 3 months after 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

Outcome measures
Measure
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
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=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
Disability Severity: Oswestry Disability Index
13.84 score on a scale
Standard Deviation 6.44
14.20 score on a scale
Standard Deviation 6.52
13.35 score on a scale
Standard Deviation 4.35
16.10 score on a scale
Standard Deviation 3.89

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

Outcome measures
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
Patient Reported Quality of Life: Short Form 36 Physical Functioning
53.1 score on a scale
Standard Deviation 13.08
50.75 score on a scale
Standard Deviation 14.53
45.9 score on a scale
Standard Deviation 12.54
50.71 score on a scale
Standard Deviation 12.97

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

Outcome measures
Measure
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
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=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
Patient Reported Quality of Life: Short Form 36 Physical Functioning
77.63 score on a scale
Standard Deviation 14.75
74 score on a scale
Standard Deviation 13.53
75 score on a scale
Standard Deviation 15.39
74.05 score on a scale
Standard Deviation 15.46

SECONDARY outcome

Timeframe: 1 month after 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

Outcome measures
Measure
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
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=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
Patient Reported Quality of Life: Short Form 36 Physical Functioning
68.11 score on a scale
Standard Deviation 16.69
61.70 score on a scale
Standard Deviation 19.47
67.20 score on a scale
Standard Deviation 16.26
57.86 score on a scale
Standard Deviation 16.32

SECONDARY outcome

Timeframe: 3 months after 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

Outcome measures
Measure
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
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=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
Patient Reported Quality of Life: Short Form 36 Physical Functioning
58.84 score on a scale
Standard Deviation 13.26
55.15 score on a scale
Standard Deviation 15.35
56.65 score on a scale
Standard Deviation 16.27
54.05 score on a scale
Standard Deviation 14.63

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

Outcome measures
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
Spinal Mobility: Schober Test
4.09 centimeters
Standard Deviation 0.58
4.37 centimeters
Standard Deviation 0.77
3.75 centimeters
Standard Deviation 0.88
4.38 centimeters
Standard Deviation 0.72

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

Outcome measures
Measure
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
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=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
Spinal Mobility: Schober Test
4.36 centimeters
Standard Deviation 0.43
4.37 centimeters
Standard Deviation 0.77
4.27 centimeters
Standard Deviation 0.63
4.59 centimeters
Standard Deviation 0.49

SECONDARY outcome

Timeframe: 1 month after 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

Outcome measures
Measure
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
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=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
Spinal Mobility: Schober Test
4.36 centimeters
Standard Deviation 0.43
4.42 centimeters
Standard Deviation 0.74
4.27 centimeters
Standard Deviation 0.63
4.54 centimeters
Standard Deviation 0.54

SECONDARY outcome

Timeframe: 3 months after 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

Outcome measures
Measure
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
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=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
Spinal Mobility: Schober Test
4.36 centimeters
Standard Deviation 0.43
4.42 centimeters
Standard Deviation 0.74
4.2 centimeters
Standard Deviation 0.61
4.54 centimeters
Standard Deviation 0.54

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 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Outcome measures

Outcome measures
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
Patient Reported Quality of Life: Short Form-36 Mental Health
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
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

Outcome measures
Measure
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
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=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
Patient Reported Quality of Life: Short Form-36 Mental Health
79.79 score on a scale
Standard Deviation 7.48
78.6 score on a scale
Standard Deviation 5.51
78 score on a scale
Standard Deviation 5.51
77.52 score on a scale
Standard Deviation 2.18

SECONDARY outcome

Timeframe: 1 month after 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 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Outcome measures

Outcome measures
Measure
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
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=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
Patient Reported Quality of Life: Short Form-36 Mental Health
77.16 score on a scale
Standard Deviation 9.29
73.10 score on a scale
Standard Deviation 7.96
76.6 score on a scale
Standard Deviation 7.05
71.81 score on a scale
Standard Deviation 4.97

SECONDARY outcome

Timeframe: 3 months after 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 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Outcome measures

Outcome measures
Measure
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
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=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
Patient Reported Quality of Life: Short Form-36 Mental Health
74.42 score on a scale
Standard Deviation 7.96
72.1 score on a scale
Standard Deviation 7.90
73.60 score on a scale
Standard Deviation 7.93
71.33 score on a scale
Standard Deviation 4.83

Adverse Events

Kinesio Tape

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham Kinesio Taping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Local Anesthetic

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Local Serum Physiologic

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adem Erbirol

SultanAbdulhamid

Phone: +905426608788

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place