Chronic Low Back PainNCT03895307
Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
A study testing kinesio tape, local anesthetic and local serum physiologic in people with Chronic Low Back Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- kinesio tape, local anesthetic and local serum physiologic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- 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
Show all 10Show fewer
- Needle phobia
- Is allergic to lidocaine
- Kinesio tape allergy
- Wound, infection, burn, allergic lesions in the application area
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sultan 2.Abdülhamid Han Training and Research Hospital
Istanbul, Eyalet/Yerleşke, 34000
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Eyalet/Yerleşke, 34000
About this study
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:
- 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- kinesio tape, local anesthetic, local serum physiologic
- Keywords
- chronic low back pain, kinesio taping, injection, local anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio tapeOther
two 15 cm I type kinesio tape applied longitudinally
local anestheticOther
local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
local serum physiologicOther
serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| kinesio taping | Experimental | two 15 cm I type kinesio tape applied longitudinally Receives: Other: kinesio tape |
| sham kinesio taping | Placebo comparator | two 15 cm I type kinesio tape applied longitudinally but without stretching Receives: Other: kinesio tape |
| local anesthetic | Experimental | 18-20 cc %0.5 lidocaine subcutaneous injection Receives: Other: local anesthetic |
| local serum physiologic | Placebo comparator | 18-20 cc % 0.09 NaCl subcutaneous injection Receives: Other: local serum physiologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Measured: day 0 (before intervention)
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Measured: day 16 (after 6th application)
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Measured: 1 month after intervention
Pain Severity: Visual Analog Scale
visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Measured: 3 months after intervention
Secondary outcomes (16)
Disability Severity: Oswestry Disabiliy Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Measured: day 0 (before intervention)
Disability Severity: Oswestry Disability Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Measured: day 16 (after 6th application)
Disability Severity: Oswestry Disability Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Measured: 1 month after intervention
Disability Severity: Oswestry Disability Index
Oswestry Disabiliy Index:
minimum score: 0 maximum score: 50. Higher scores reflect more severe disability
Measured: 3 months after intervention
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
Measured: day 0 (before intervention)
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
Measured: day 16 (after 6th application)
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
Measured: 1 month after intervention
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
Measured: 3 months after intervention
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.
Measured: day 0 (before intervention)
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.
Measured: day 16 (after 6th application)
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.
Measured: 1 month after intervention
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.
Measured: 3 months after intervention
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.
Measured: day 0 before intervention
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.
Measured: day 16 (after 6th application)
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.
Measured: 1 month after intervention
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.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ADEM ERBİROL, Study director, sultan abdulhamid han
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895307
- Sponsor's protocol ID
- ademerbirol
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2019
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: other researchers would get information from the main researcher. therefore it was not shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03895307
- Acronym / sponsor ID
- ademerbirol
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, kinesio taping, injection, local anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| kinesio taping | Experimental | Other: kinesio tapetwo 15 cm I type kinesio tape applied longitudinally |
| sham kinesio taping | Placebo comparator | Other: kinesio tapetwo 15 cm I type kinesio tape applied longitudinally but without stretching |
| local anesthetic | Experimental | Other: local anesthetic18-20 cc %0.5 lidocaine subcutaneous injection |
| local serum physiologic | Placebo comparator | Other: local serum physiologic18-20 cc % 0.09 NaCl subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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-
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinesio tapetwo 15 cm I type kinesio tape applied longitudinally | Other | kinesio taping, sham kinesio taping |
| local anestheticlocal anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection | Other | local anesthetic |
| local serum physiologicserum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection | Other | local serum physiologic |
Primary outcome
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
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
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
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
16 secondary outcomes
Disability Severity: Oswestry Disabiliy Index
Time frame: day 0 (before intervention)
Disability Severity: Oswestry Disability Index
Time frame: day 16 (after 6th application)
Disability Severity: Oswestry Disability Index
Time frame: 1 month after intervention
Disability Severity: Oswestry Disability Index
Time frame: 3 months after intervention
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Time frame: day 0 (before intervention)
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Time frame: day 16 (after 6th application)
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Time frame: 1 month after intervention
Patient Reported Quality of Life: Short Form 36 Physical Functioning
Time frame: 3 months after intervention
Spinal Mobility: Schober Test
Time frame: day 0 (before intervention)
Spinal Mobility: Schober Test
Time frame: day 16 (after 6th application)
Spinal Mobility: Schober Test
Time frame: 1 month after intervention
Spinal Mobility: Schober Test
Time frame: 3 months after intervention
Patient Reported Quality of Life: Short Form-36 Mental Health
Time frame: day 0 before intervention
Patient Reported Quality of Life: Short Form-36 Mental Health
Time frame: day 16 (after 6th application)
Patient Reported Quality of Life: Short Form-36 Mental Health
Time frame: 1 month after intervention
Patient Reported Quality of Life: Short Form-36 Mental Health
Time frame: 3 months after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. other researchers would get information from the main researcher. therefore it was not shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADEM ERBİROL study director
sultan abdulhamid han
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio tape, local anesthetic and local serum physiologic in people with Chronic Low Back Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity: Visual Analog Scale (time frame: day 0 (before intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.