Low Back Pain, RecurrentNCT04943640
The Additional Effect of Different Taping Applications in Patients With Lumbar Radiculopathy
A study testing kinesio taping and rigid taping in people with Low Back Pain, Recurrent and Kinesiotape, run by Ankara Yildirim Beyazıt University at 3 sites in Turkey (Türkiye).
Trial summary
Our study aims to compare the therapeutic effects of different taping materials and techniques on pain, functionality, and tissue temperature in patients with lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain, Recurrent, Kinesiotape, Quality of Life
- What is being tested?
- kinesio taping and rigid taping
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The criterion for inclusion in the study for volunteers was low back pain due to lumbar radiculopathy.
Who cannot join
- Exclusion criteria were skin disease, central nervous system damage, tumour in the spine, surgical operation of the spine, pregnancy, and rheumatic disease
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Ankara, 06760
Departmant of Health Services Vocational School, Physical Thraphy and Rehablitation, Ufuk University
Ankara
Faculty of Health Sciences, Departmant of Physiotherapy and Rehabilitation, Baskent University
Ankara
About this study
Official title: The Additional Effect of Different Taping Applications on Pain, Functionality, and Tissue Temperature in Patients With Lumbar Radiculopathy: A Randomized Controlled Study
Our study aims to compare the therapeutic effects of different taping materials and techniques on pain, functionality, and tissue temperature in patients with lumbar radiculopathy.
Read the detailed description
Pain occurs due to the intervertebral disc; ligaments in the region; or degeneration, strain, and sprains in the muscles, neurogenic, inflammatory, infectious, or neoplastic problems caused by structures in and around the spine . Low back pain is a serious health problem, with a lifetime prevalence of 84% . According to the American Society of Pain's clinical practice guidelines, low back pain is classified into three categories: nonspecific low back pain, radiculopathy-induced low back pain, and low back pain associated with another specific cause. A multidisciplinary approach is recommended for the treatment of low back pain. Before pharmacological treatments, cognitive behavioral therapy, physiotherapy exercise programmes, electrical physical therapy modalities, manual therapy, and psychological therapy are frequently referenced treatment options. Taping is one of the conservative physical therapy methods that is often a preferred treatment in clinics. Rigid (athletic) taping and kinesiological taping are the most preferred taping techniques . Non-elastic taping material is used in the rigid taping application. It is used to position soft tissue and ensure that the tissues come together, are protected from contact, create compression, and prevent local swelling. Studies supporting the sensorimotor and proprioceptive sensory enhancing effects of rigid tape, which provides very good sensory input over the skin, are found in previous studies [7-9]. Unlike rigid tape, kinesio tape can be stretched up to 140% of its resting length due to its structure, which is the approximate stretching capacity of normal skin .
Although there are various studies related to this topic, there is still no consensus on the effectiveness of taping in patients with low back pain who have disc degeneration. The reason for this is that some studies show the positive effect of kinesio taping on the reduction of low back pain, but some cannot show the effect of taping or find any changes . The healing mechanisms of different taping treatments have not been fully clarified. Moreover, local temperature, which is one of the indicators of vascularization and tissue healing, has not been investigated widely. Our study aims to examine the effects of different taping materials and techniques on pain, functionality, and local tissue temperature in patients with lumbar radiculopathy.
- Conditions
- Low Back Pain, Recurrent, Kinesiotape, Quality of Life, Physiotherapy
- Being tested
- kinesio taping, rigid taping, placebo taping
- Keywords
- low back pain, kinesiotape, quality of life, skin temperature, physiotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio tapingOther
Kinesio tape was developed by Kenzo Kase in the 1970s. It is an elastic tape, and its adhesive face is sinusoidal wavy. This feature has been shown to increase daily living activities and functions, as it supports the tissue while also allowing movement [12]. Kinesio tape lifts the skin and subcutaneous soft tissues of the fascia, which are painful and inflamed regions upon contractions seen in the tissue after tense adhesion to the skin. Therefore, it has been reported to reduce oedema and inflammation by creating more space and providing blood and lymphatic fluid flow.
rigid tapingOther
The tape material used in rigid (athletic) tape application is hard. It is used to position and unite the soft tissue, to protect the tissue from impact and to prevent local swelling.There are studies in the literature supporting the sensorimotor and proprioceptive sensation-enhancing effect of the athletic band, which provides a very good sensory input through the skin.
placebo tapingOther
Placebo taping was applied to the patients in this group, using betafix, an elastic fixation band, as the material. The patient was told that taping would be applied. A straight line betafix was applied to the non-painful scapular inferior level of the spine on the right and left sides of the standing patient.
| Study group | Role | What they receive |
|---|---|---|
| kinesio taping | Experimental | The patient was advised to clean the skin with alcohol and shave the hairy areas. The standing patient was asked to take off high heels if he/she was wearing them.
The paravertebral technique was used with 5 cm x 5 m kinesio tape material. While the patient was standing in an upright position, two longitudinal pieces were cut by taking the tape and slightly rolling its corners. The patient was asked to lean forward. The lower end of the tape was attached 7 cm below the sacroiliac joint at the level of the paravertebral muscles and the patient was bent forward. The patient was asked to do a slight rotation to the left, and while in this position, the tape was attached to T11-T12 without stretching at all. Kinesio tape was attached to the opposite side of the vertebrae with the same procedure. Receives: Other: kinesio taping |
| rigid taping | Experimental | The patient was asked to lean forward, and 5 cm x 5 m rigid tape material was used in the right paravertebral region. When bonding the tape, first, the lower end of the tape was attached 7 cm below the sacroiliac joint at the level of the paravertebral muscles and the patient was bent forward. Then, the patient was asked to do a slight rotation to the left, and while in this position, the hypoallergenic tape (beta fix) was applied with no tension [23]. Then, rigid tape was applied upward onto the paravertebral muscles. The left paravertebral region was taped with the same procedure as the right paravertebral region . Receives: Other: rigid taping |
| placebo taping groups | Placebo comparator | Placebo taping was applied to patients in this group using betafix, an elastic stabilization tape, as material. A straight line of betafix was applied to the non-painful scapular inferior alignment of the spine, right and left, while the patient was standing upright.
Treatment with taping was administered to all groups every 2 days by the same physiotherapist . Receives: Other: placebo taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Roland-Morris Disability Questionnaire score at five weeks
The Roland-Morris Disability Questionnaire is a 24-item survey designed to assess the degree of functional limitation in patients with low back pain. The questionnaire answers are Yes-No (Yes: 1 point, No: 0 points), and high scores indicate severe disability
Measured: before and after five weeks of treatment (10 sessions)
Change from Tissue temperature at five weeks
Regional tissue temperature was measured by digital electronic infrared thermography (FLIR-e63900, Wilsonville, OR, USA). This method is a non-invasive assessment tool that does not require intervention by the investigator. The investigator can see changes in the skin surface temperature of the patient and, the thermal differences of the measured point are shown on the monitor.
Measured: before and after five weeks of treatment (10 sessions)
Secondary outcomes (2)
Change from The Oswestry Low Pain Disability Questionnaire score at five weeks
The Oswestry Disability Index measures the degree to which low back pain affects the daily life activities of patients in 10 different aspects (severity of pain, personal care, lifting, walking, sitting, standing, sleeping, degree of change of pain, social life, and travel). There are six expressions under each item that mark what is appropriate for the patient's condition. The first phrase is scored as "0", and the sixth phrase as "5"; 0-4 points is considered no disability, 5-14 points light disability, 15-24 points medium disability, 25-34 points serious disability, and 35-50 points total functional disability. The minimum score taken from the scale is 0, and the maximum score is 50. Fifty points indicate the highest level of functional inadequacy .
Measured: before and after five weeks of treatment (10 sessions)
Change from Pain severity at five weeks
The Visual Analogue Scale (VAS) was used to evaluate the severity of pain felt during the activities and rest of patients. The scale is horizontal in the form of a line 10 cm long, starting with "no pain" and ending with "excruciating pain". The pain was measured and recorded as "cm" between the point marked with no onset .
Measured: before and after each session( five weeks of treatmant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Nov 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tugce Bozkurt, Principal investigator, Ufuk UniversityRabia Tugba Kilic, Study director, Ankara Yildirim Beyazıt UniversityHayri Baran Yosmaoğlu, Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943640
- Sponsor's protocol ID
- KA18/340
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silva Parreira Pdo C, Menezes Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta Silva T, da Luz Junior MA, Pena Costa LO. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. J Physiother. 2013 Mar;59(1):52; discussion 52. doi: 10.1016/S1836-9553(13)70147-4.
PubMed 23419916Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
PubMed 15129077Kucukdeveci AA, Tennant A, Elhan AH, Niyazoglu H. Validation of the Turkish version of the Roland-Morris Disability Questionnaire for use in low back pain. Spine (Phila Pa 1976). 2001 Dec 15;26(24):2738-43. doi: 10.1097/00007632-200112150-00024.
PubMed 11740366Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Xue EY, Chandler LK, Viviano SL, Keith JD. Use of FLIR ONE Smartphone Thermography in Burn Wound Assessment. Ann Plast Surg. 2018 Apr;80(4 Suppl 4):S236-S238. doi: 10.1097/SAP.0000000000001363.
PubMed 29489530
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additional Effect of Different Taping Applications on Pain, Functionality, and Tissue Temperature in Patients With Lumbar Radiculopathy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04943640
- Acronym / sponsor ID
- KA18/340
- Conditions
- Low Back Pain, Recurrent, Kinesiotape, Quality of Life, Physiotherapy
- Keywords
- low back pain, kinesiotape, quality of life, skin temperature, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aims to compare the therapeutic effects of different taping materials and techniques on pain, functionality, and tissue temperature in patients with lumbar radiculopathy.
Detailed description
Pain occurs due to the intervertebral disc; ligaments in the region; or degeneration, strain, and sprains in the muscles, neurogenic, inflammatory, infectious, or neoplastic problems caused by structures in and around the spine . Low back pain is a serious health problem, with a lifetime prevalence of 84% . According to the American Society of Pain's clinical practice guidelines, low back pain is classified into three categories: nonspecific low back pain, radiculopathy-induced low back pain, and low back pain associated with another specific cause. A multidisciplinary approach is recommended for the treatment of low back pain. Before pharmacological treatments, cognitive behavioral therapy, physiotherapy exercise programmes, electrical physical therapy modalities, manual therapy, and psychological therapy are frequently referenced treatment options. Taping is one of the conservative physical therapy methods that is often a preferred treatment in clinics. Rigid (athletic) taping and kinesiological taping are the most preferred taping techniques . Non-elastic taping material is used in the rigid taping application. It is used to position soft tissue and ensure that the tissues come together, are protected from contact, create compression, and prevent local swelling. Studies supporting the sensorimotor and proprioceptive sensory enhancing effects of rigid tape, which provides very good sensory input over the skin, are found in previous studies [7-9]. Unlike rigid tape, kinesio tape can be stretched up to 140% of its resting length due to its structure, which is the approximate stretching capacity of normal skin .
Although there are various studies related to this topic, there is still no consensus on the effectiveness of taping in patients with low back pain who have disc degeneration. The reason for this is that some studies show the positive effect of kinesio taping on the reduction of low back pain, but some cannot show the effect of taping or find any changes . The healing mechanisms of different taping treatments have not been fully clarified. Moreover, local temperature, which is one of the indicators of vascularization and tissue healing, has not been investigated widely. Our study aims to examine the effects of different taping materials and techniques on pain, functionality, and local tissue temperature in patients with lumbar radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kinesio taping | Experimental | Other: kinesio tapingThe patient was advised to clean the skin with alcohol and shave the hairy areas. The standing patient was asked to take off high heels if he/she was wearing them. The paravertebral technique was used with 5 cm x 5 m kinesio tape material. While the patient was standing in an upright position, two longitudinal pieces were cut by taking the tape and slightly rolling its corners. The patient was asked to lean forward. The lower end of the tape was attached 7 cm below the sacroiliac joint at the level of the paravertebral muscles and the patient was bent forward. The patient was asked to do a slight rotation to the left, and while in this position, the tape was attached to T11-T12 without stretching at all. Kinesio tape was attached to the opposite side of the vertebrae with the same procedure. |
| rigid taping | Experimental | Other: rigid tapingThe patient was asked to lean forward, and 5 cm x 5 m rigid tape material was used in the right paravertebral region. When bonding the tape, first, the lower end of the tape was attached 7 cm below the sacroiliac joint at the level of the paravertebral muscles and the patient was bent forward. Then, the patient was asked to do a slight rotation to the left, and while in this position, the hypoallergenic tape (beta fix) was applied with no tension [23]. Then, rigid tape was applied upward onto the paravertebral muscles. The left paravertebral region was taped with the same procedure as the right paravertebral region . |
| placebo taping groups | Placebo comparator | Other: placebo tapingPlacebo taping was applied to patients in this group using betafix, an elastic stabilization tape, as material. A straight line of betafix was applied to the non-painful scapular inferior alignment of the spine, right and left, while the patient was standing upright. Treatment with taping was administered to all groups every 2 days by the same physiotherapist . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The criterion for inclusion in the study for volunteers was low back pain due to lumbar radiculopathy.
Key exclusion criteria (1 listed)
- Exclusion criteria were skin disease, central nervous system damage, tumour in the spine, surgical operation of the spine, pregnancy, and rheumatic disease
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 tapingKinesio tape was developed by Kenzo Kase in the 1970s. It is an elastic tape, and its adhesive face is sinusoidal wavy. This feature has been shown to increase daily living activities and functions, as it supports the tissue while also allowing movement [12]. Kinesio tape lifts the skin and subcutaneous soft tissues of the fascia, which are painful and inflamed regions upon contractions seen in the tissue after tense adhesion to the skin. Therefore, it has been reported to reduce oedema and inflammation by creating more space and providing blood and lymphatic fluid flow. | Other | kinesio taping |
| rigid tapingThe tape material used in rigid (athletic) tape application is hard. It is used to position and unite the soft tissue, to protect the tissue from impact and to prevent local swelling.There are studies in the literature supporting the sensorimotor and proprioceptive sensation-enhancing effect of the athletic band, which provides a very good sensory input through the skin. | Other | rigid taping |
| placebo tapingPlacebo taping was applied to the patients in this group, using betafix, an elastic fixation band, as the material. The patient was told that taping would be applied. A straight line betafix was applied to the non-painful scapular inferior level of the spine on the right and left sides of the standing patient. | Other | placebo taping groups |
Primary outcome
Change from Roland-Morris Disability Questionnaire score at five weeks
Time frame: before and after five weeks of treatment (10 sessions)
The Roland-Morris Disability Questionnaire is a 24-item survey designed to assess the degree of functional limitation in patients with low back pain. The questionnaire answers are Yes-No (Yes: 1 point, No: 0 points), and high scores indicate severe disability
Change from Tissue temperature at five weeks
Time frame: before and after five weeks of treatment (10 sessions)
Regional tissue temperature was measured by digital electronic infrared thermography (FLIR-e63900, Wilsonville, OR, USA). This method is a non-invasive assessment tool that does not require intervention by the investigator. The investigator can see changes in the skin surface temperature of the patient and, the thermal differences of the measured point are shown on the monitor.
2 secondary outcomes
Change from The Oswestry Low Pain Disability Questionnaire score at five weeks
Time frame: before and after five weeks of treatment (10 sessions)
Change from Pain severity at five weeks
Time frame: before and after each session( five weeks of treatmant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 23419916Silva Parreira Pdo C, Menezes Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta Silva T, da Luz Junior MA, Pena Costa LO. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. J Physiother. 2013 Mar;59(1):52; discussion 52. doi: 10.1016/S1836-9553(13)70147-4.
- Background: PubMed 15129077Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
- Background: PubMed 11740366Kucukdeveci AA, Tennant A, Elhan AH, Niyazoglu H. Validation of the Turkish version of the Roland-Morris Disability Questionnaire for use in low back pain. Spine (Phila Pa 1976). 2001 Dec 15;26(24):2738-43. doi: 10.1097/00007632-200112150-00024.
- Background: PubMed 6226917Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
- Background: PubMed 29489530Xue EY, Chandler LK, Viviano SL, Keith JD. Use of FLIR ONE Smartphone Thermography in Burn Wound Assessment. Ann Plast Surg. 2018 Apr;80(4 Suppl 4):S236-S238. doi: 10.1097/SAP.0000000000001363.
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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.
Tugce Bozkurt principal investigator
Ufuk University
Rabia Tugba Kilic study director
Ankara Yildirim Beyazıt University
Hayri Baran Yosmaoğlu study chair
Baskent University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio taping and rigid taping in people with Low Back Pain, Recurrent and Kinesiotape, run by Ankara Yildirim Beyazıt University at 3 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 1 inclusion and 1 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Roland-Morris Disability Questionnaire score at five weeks (time frame: before and after five weeks of treatment (10 sessions)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943640, which also lists 5 linked publications.
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 29 Jun 2021.