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Completed

NCT Number: NCT03895307

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan 2.Abdülhamid Han Training and Research Hospital, Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

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About this study

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:
  • Future points on spinous projections from L1 to L5
  • Lumbar region 2 from the middle point of the spinous output bilateral and 2 cm to 4 cm lateral points
  • To each point of the iliac lobe of iliac crest will be injected subcutaneously with 0.5 ml 0.5% lidocaine-containing local anesthetic.
  • 6 mm 30 gauge needle tip will be used for injection.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Under 18 years of age under 75 years
  • Chronic mechanic (decreased with resting and resting) for at least 3 months
  • Visual Analogue Scale score of at least 60-

Exclusion criteria

  • Having mental problems
  • Having the disease affecting the peripheral and central nervous system
  • Have received physical therapy in the lumbar region within the last 3 months
  • Injection into the lumbar region within the last 3 months
  • Having a history of waist region surgery
  • Low motor dysfunction in lower extremity in physical examination
  • Needle phobia
  • Is allergic to lidocaine
  • Kinesio tape allergy
  • Wound, infection, burn, allergic lesions in the application area

Treatment and study plan

Kinesio Tape

Other

two 15 cm I type kinesio tape applied longitudinally

Local anesthetic

Other

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

local serum physiologic

Other

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

Primary outcomes

  1. Pain Severity: Visual Analog Scale

    Time frame: day 0 (before intervention)

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

  2. Pain Severity: Visual Analog Scale

    Time frame: day 16 (after 6th application)

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

  3. Pain Severity: Visual Analog Scale

    Time frame: 1 month after intervention

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

  4. Pain Severity: Visual Analog Scale

    Time frame: 3 months after intervention

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

Secondary outcomes

  1. Disability Severity: Oswestry Disabiliy Index

    Time frame: day 0 (before intervention)

    Oswestry Disabiliy Index:

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

  2. Disability Severity: Oswestry Disability Index

    Time frame: day 16 (after 6th application)

    Oswestry Disabiliy Index:

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

  3. Disability Severity: Oswestry Disability Index

    Time frame: 1 month after intervention

    Oswestry Disabiliy Index:

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

  4. Disability Severity: Oswestry Disability Index

    Time frame: 3 months after intervention

    Oswestry Disabiliy Index:

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

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

    Time frame: day 0 (before intervention)

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

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

    Time frame: day 16 (after 6th application)

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

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

    Time frame: 1 month after intervention

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

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

    Time frame: 3 months after intervention

    short form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    short form 36 physical functioning subscale scores are given. minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life

  9. Spinal Mobility: Schober Test

    Time frame: day 0 (before intervention)

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).

    Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.

    A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.

    The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.

    Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

  10. Spinal Mobility: Schober Test

    Time frame: day 16 (after 6th application)

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).

    Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.

    A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.

    The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.

    Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

  11. Spinal Mobility: Schober Test

    Time frame: 1 month after intervention

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).

    Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.

    A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.

    The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.

    Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

  12. Spinal Mobility: Schober Test

    Time frame: 3 months after intervention

    Schober's test is classically used to determine if there is a decrease in lumbar spine range of motion (flexion).

    Patient is standing, examiner marks the L5 spinous process by drawing a horizontal line across the patients back.

    A second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed.

    The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion.

    Less than 5cm increase in length with forward flexion: Decreased lumbar spine range of motion.

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

    Time frame: day 0 before intervention

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

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

    Time frame: day 16 (after 6th application)

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

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

    Time frame: 1 month after intervention

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

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

    Time frame: 3 months after intervention

    Short Form 36: The SF-36 form generates eight subscales. The eight subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

    Short Form-36 Mental health subscale scores are given. Mental minimum score: 0 maximum score: 100. Higher scores indicate a better of quality of life.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2019
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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