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CompletedNCT03895307Updated Apr 13, 2021Results posted

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

An interventional study of kinesio tape and local anesthetic in Chronic Low Back Pain, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 2 sites in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-13.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Chronic Low Back Pain

Keywords

  • chronic low back pain
  • kinesio taping
  • injection
  • local anesthetic
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 84 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    kinesio taping

    two 15 cm I type kinesio tape applied longitudinally

    Other: kinesio tape

  • Placebo comparator
    sham kinesio taping

    two 15 cm I type kinesio tape applied longitudinally but without stretching

    Other: kinesio tape

  • Experimental
    local anesthetic

    18-20 cc %0.5 lidocaine subcutaneous injection

    Other: local anesthetic

  • Placebo comparator
    local serum physiologic

    18-20 cc % 0.09 NaCl subcutaneous injection

    Other: local serum physiologic

Interventions

  • Otherkinesio tape

    two 15 cm I type kinesio tape applied longitudinally

  • Otherlocal anesthetic

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

  • Otherlocal serum physiologic

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

06

What researchers measure

Primary outcomes

  1. Pain Severity: Visual Analog Scale

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

    Time frame: day 0 (before intervention)

  2. Pain Severity: Visual Analog Scale

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

    Time frame: day 16 (after 6th application)

  3. Pain Severity: Visual Analog Scale

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

    Time frame: 1 month after intervention

  4. Pain Severity: Visual Analog Scale

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

    Time frame: 3 months after intervention

Secondary outcomes

  1. Disability Severity: Oswestry Disabiliy Index

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

    Time frame: day 0 (before intervention)

  2. Disability Severity: Oswestry Disability Index

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

    Time frame: day 16 (after 6th application)

  3. Disability Severity: Oswestry Disability Index

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

    Time frame: 1 month after intervention

  4. Disability Severity: Oswestry Disability Index

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

    Time frame: 3 months after intervention

  5. Patient Reported Quality of Life: Short Form 36 Physical Functioning

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

    Time frame: day 0 (before intervention)

  6. Patient Reported Quality of Life: Short Form 36 Physical Functioning

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

    Time frame: day 16 (after 6th application)

  7. Patient Reported Quality of Life: Short Form 36 Physical Functioning

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

    Time frame: 1 month after intervention

  8. Patient Reported Quality of Life: Short Form 36 Physical Functioning

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

    Time frame: 3 months after intervention

  9. Spinal Mobility: Schober Test

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

    Time frame: day 0 (before intervention)

  10. Spinal Mobility: Schober Test

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

    Time frame: day 16 (after 6th application)

  11. Spinal Mobility: Schober Test

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

    Time frame: 1 month after intervention

  12. Spinal Mobility: Schober Test

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

    Time frame: 3 months after intervention

  13. Patient Reported Quality of Life: Short Form-36 Mental Health

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

    Time frame: day 0 before intervention

  14. Patient Reported Quality of Life: Short Form-36 Mental Health

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

    Time frame: day 16 (after 6th application)

  15. Patient Reported Quality of Life: Short Form-36 Mental Health

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

    Time frame: 1 month after intervention

  16. Patient Reported Quality of Life: Short Form-36 Mental Health

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

    Time frame: 3 months after intervention

07

Results

Posted Jul 2, 2020

Participant flow

Participant flow — Overall Study
MilestoneKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Started21202221
Completed19202021
Not completed2020

Outcome measures

PrimaryPain Severity: Visual Analog Scale

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

Time frame:
day 0 (before intervention)
Reported as:
Mean · score on a scale
Pain Severity: Visual Analog Scale
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Pain Severity: Visual Analog Scale7.26 ± 0.87.75 ± 0.447.8 ± 0.897.62 ± 0.92
PrimaryPain Severity: Visual Analog Scale

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

Time frame:
day 16 (after 6th application)
Reported as:
Mean · score on a scale
Pain Severity: Visual Analog Scale
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Pain Severity: Visual Analog Scale2.89 ± 2.13.35 ± 2.112.85 ± 1.983.52 ± 2.13
PrimaryPain Severity: Visual Analog Scale

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

Time frame:
1 month after intervention
Reported as:
Mean · score on a scale
Pain Severity: Visual Analog Scale
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Pain Severity: Visual Analog Scale3.58 ± 2.564.65 ± 2.993.65 ± 2.365.81 ± 2.18
PrimaryPain Severity: Visual Analog Scale

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

Time frame:
3 months after intervention
Reported as:
Mean · score on a scale
Pain Severity: Visual Analog Scale
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Pain Severity: Visual Analog Scale4.42 ± 2.415.20 ± 2.945 ± 2.776.48 ± 2.22
SecondaryDisability Severity: Oswestry Disabiliy Index

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

Time frame:
day 0 (before intervention)
Reported as:
Mean · score on a scale
Disability Severity: Oswestry Disabiliy Index
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Disability Severity: Oswestry Disabiliy Index17.42 ± 2.6518.30 ± 3.4517.1 ± 2.3817.57 ± 1.72
SecondaryDisability Severity: Oswestry Disability Index

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

Time frame:
day 16 (after 6th application)
Reported as:
Mean · score on a scale
Disability Severity: Oswestry Disability Index
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Disability Severity: Oswestry Disability Index7.68 ± 6.676.50 ± 6.666.15 ± 4.9510.43 ± 5.07
SecondaryDisability Severity: Oswestry Disability Index

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

Time frame:
1 month after intervention
Reported as:
Mean · score on a scale
Disability Severity: Oswestry Disability Index
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Disability Severity: Oswestry Disability Index10.84 ± 8.2110.50 ± 7.588.85 ± 6.6714.38 ± 4.57
SecondaryDisability Severity: Oswestry Disability Index

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

Time frame:
3 months after intervention
Reported as:
Mean · score on a scale
Disability Severity: Oswestry Disability Index
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Disability Severity: Oswestry Disability Index13.84 ± 6.4414.20 ± 6.5213.35 ± 4.3516.10 ± 3.89
SecondaryPatient Reported Quality of Life: Short Form 36 Physical Functioning

short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

Time frame:
day 0 (before intervention)
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form 36 Physical Functioning
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form 36 Physical Functioning53.1 ± 13.0850.75 ± 14.5345.9 ± 12.5450.71 ± 12.97
SecondaryPatient Reported Quality of Life: Short Form 36 Physical Functioning

short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

Time frame:
day 16 (after 6th application)
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form 36 Physical Functioning
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form 36 Physical Functioning77.63 ± 14.7574 ± 13.5375 ± 15.3974.05 ± 15.46
SecondaryPatient Reported Quality of Life: Short Form 36 Physical Functioning

short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

Time frame:
1 month after intervention
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form 36 Physical Functioning
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form 36 Physical Functioning68.11 ± 16.6961.70 ± 19.4767.20 ± 16.2657.86 ± 16.32
SecondaryPatient Reported Quality of Life: Short Form 36 Physical Functioning

short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

Time frame:
3 months after intervention
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form 36 Physical Functioning
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form 36 Physical Functioning58.84 ± 13.2655.15 ± 15.3556.65 ± 16.2754.05 ± 14.63
SecondarySpinal Mobility: Schober Test

Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

Time frame:
day 0 (before intervention)
Reported as:
Mean · centimeters
Spinal Mobility: Schober Test
centimetersKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Spinal Mobility: Schober Test4.09 ± 0.584.37 ± 0.773.75 ± 0.884.38 ± 0.72
SecondarySpinal Mobility: Schober Test

Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

Time frame:
day 16 (after 6th application)
Reported as:
Mean · centimeters
Spinal Mobility: Schober Test
centimetersKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Spinal Mobility: Schober Test4.36 ± 0.434.37 ± 0.774.27 ± 0.634.59 ± 0.49
SecondarySpinal Mobility: Schober Test

Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

Time frame:
1 month after intervention
Reported as:
Mean · centimeters
Spinal Mobility: Schober Test
centimetersKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Spinal Mobility: Schober Test4.36 ± 0.434.42 ± 0.744.27 ± 0.634.54 ± 0.54
SecondarySpinal Mobility: Schober Test

Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion). Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back. A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion. Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

Time frame:
3 months after intervention
Reported as:
Mean · centimeters
Spinal Mobility: Schober Test
centimetersKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Spinal Mobility: Schober Test4.36 ± 0.434.42 ± 0.744.2 ± 0.614.54 ± 0.54
SecondaryPatient Reported Quality of Life: Short Form-36 Mental Health

Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Time frame:
day 0 before intervention
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form-36 Mental Health
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form-36 Mental Health68 ± 067.5 ± 2.2368 ± 068 ± 0
SecondaryPatient Reported Quality of Life: Short Form-36 Mental Health

Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Time frame:
day 16 (after 6th application)
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form-36 Mental Health
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form-36 Mental Health79.79 ± 7.4878.6 ± 5.5178 ± 5.5177.52 ± 2.18
SecondaryPatient Reported Quality of Life: Short Form-36 Mental Health

Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Time frame:
1 month after intervention
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form-36 Mental Health
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form-36 Mental Health77.16 ± 9.2973.10 ± 7.9676.6 ± 7.0571.81 ± 4.97
SecondaryPatient Reported Quality of Life: Short Form-36 Mental Health

Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Time frame:
3 months after intervention
Reported as:
Mean · score on a scale
Patient Reported Quality of Life: Short Form-36 Mental Health
score on a scaleKinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum Physiologic
Patient Reported Quality of Life: Short Form-36 Mental Health74.42 ± 7.9672.1 ± 7.9073.60 ± 7.9371.33 ± 4.83

Adverse events

Collected over adverse events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Kinesio Tape———
Sham Kinesio Taping———
Local Anesthetic———
Local Serum Physiologic———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Kinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum PhysiologicTotal
<=18 years00000
Between 18 and 65 years2017172074
>=65 years135110
Age, Continuous
Age, Continuous(years)Kinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum PhysiologicTotal
Mean39.67 ± 15.7247.20 ± 16.6047.82 ± 15.9541.48 ± 15.6944.05 ± 16.09
Sex: Female, Male
Sex: Female, Male(Participants)Kinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum PhysiologicTotal
Female9851234
Male121217950
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Kinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum PhysiologicTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White2120222184
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Kinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum PhysiologicTotal
Turkey2120222184
Body Mass Index
Body Mass Index(kg/m2)Kinesio TapingSham Kinesio TapingLocal AnestheticLocal Serum PhysiologicTotal
Mean27.63 ± 4.7027.25 ± 3.8827.05 ± 4.4727.05 ± 3.7327.24 ± 4.13
08

Study locations

2 sites
  • Sultan 2.Abdülhamid Han Training and Research Hospital
    Istanbul, Eyalet/Yerleşke 34000, Turkey
  • Sultan Abdülhamid Han Training and Research Hospital
    Istanbul, Eyalet/Yerleşke 34000, Turkey
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 1, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — other researchers would get information from the main researcher. therefore it was not shared.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03895307
Lead sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Responsible party
Sponsor
First posted
Mar 29, 2019
Start date
Apr 1, 2019
Primary completion
Jun 1, 2019
Completion
Aug 1, 2019
Results posted
Jul 2, 2020
Last update
Apr 13, 2021

Study contacts

ADEM ERBİROL
study director · sultan abdulhamid han

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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