Low Back PainNCT05203783
Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain
A study testing McKenzie Exercises and Kinesio Tape Application in people with Low Back Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to estimate the effect of Kinesio tape (KT) combined with supervised exercise programs compared to exercise alone on pain, lumbar range of motion, and self-reported disability of adults with mechanical low back pain (LBP). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- McKenzie Exercises and Kinesio Tape Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2021to 25 Dec 2021
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals diagnosed with mechanical LBP by a physician
Who cannot join
- Individuals with any structural or pathological changes (spondylitis, spondylolisthesis, cauda equina syndrome, lumbar canal stenosis) in lumbar spine on X-ray or MRI
- Individuals with or without neurological signs in the lower extremity suggestive upper motor or lower motor neuron involvement,
- Individuals with a history of trauma or any surgery in the region of back,
- Individuals with recent aggravation of symptoms,
- Individuals on a waiting list for spinal surgery or had a spinal surgery in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain: A Randomized Clinical Trial.
The aim of this study is to estimate the effect of Kinesio tape (KT) combined with supervised exercise programs compared to exercise alone on pain, lumbar range of motion, and self-reported disability of adults with mechanical low back pain (LBP).
Methods: This was a randomized, controlled clinical trial carried out on 60 individuals with mechanical LBP. Participants were randomly assigned to the control group (n=30) that received McKenzie exercises for 7 days or experimental group (n=30) that received KT application in addition to McKenzie exercises for 7 days. Pain measured by visual analogue scale, lumbar range of motion, and the disability measured by Oswestry Disability Index (ODI) were used as outcome measures. Pre and Post measurements were taken at baseline and after 7 days.
- Conditions
- Low Back Pain
- Being tested
- McKenzie Exercises, Kinesio Tape Application
- 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.
McKenzie ExercisesOther
McKenzie exercises: The McKenzie set consists of 5 exercises.
- Prone-lying
- Prone-extension
- Prone press ups
- Progressive extension with pillows
- Standing extension
Kinesio Tape ApplicationOther
Kinesio Tape (KT) application: Participants in the experimental group received additional taping using KT by an experience therapist with prior training in KT application. The tape was applied using the method proposed for the sacrospinalis muscle (Kase, 1996). Y-shaped tape was applied as shown in Figure 1. While the participant was in standing position, the origin of the Y-shaped tape was attached over the centre of the sacrum without stretching the tape and afterward subjects gradually bent forward. A 5-degree angle was maintained within the valley of the Y tape. The tape was changed on the fourth day
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group will receive only McKenzie exercises for 7 days. Receives: Other: McKenzie Exercises; Other: Kinesio Tape Application |
| Experimental Group | Experimental | The experimental group will receive Kinesio tape application in addition to McKenzie exercises for 7 days. Receives: Other: Kinesio Tape Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Pain was measured using a 10 cm visual analogue scale (VAS). The participants placed a mark on the line that best represented their perception of pain at that instant. The VAS score was measured in cm from the left hand end of the line to the mark.
Measured: The pain was measured at baseline
Visual analogue scale (VAS)
Pain was measured using a 10 cm visual analogue scale (VAS). The participants placed a mark on the line that best represented their perception of pain at that instant. The VAS score was measured in cm from the left hand end of the line to the mark.
Measured: The pain was measured at the end of intervention (7th day).
Secondary outcomes (2)
The Oswestry Disability Index (ODI)
The ODI was used to assess the disability. The ODI is a valid and reliable tool that measures functional disability. The scale consists of 10 sections, each section the total possible score is ranging from 0 to 5. After that, the entire score is multiplied by two to get a percentage.
Measured: The ODI was measured at study entry 2 minutes after the pain assesment.
The Oswestry Disability Index (ODI)
The ODI was used to assess the disability. The ODI is a valid and reliable tool that measures functional disability. The scale consists of 10 sections, each section the total possible score is ranging from 0 to 5. After that, the entire score is multiplied by two to get a percentage.
Measured: The ODI was measured at the end of intervention (7th day) 2 minutes after the pain assesment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start8 Aug 2021
- Primary completion10 Dec 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Marmara 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Timurtas, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203783
- Sponsor's protocol ID
- 2021-1039
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05203783
- Acronym / sponsor ID
- 2021-1039
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 24 Jan 2022 (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.
The aim of this study is to estimate the effect of Kinesio tape (KT) combined with supervised exercise programs compared to exercise alone on pain, lumbar range of motion, and self-reported disability of adults with mechanical low back pain (LBP).
Methods: This was a randomized, controlled clinical trial carried out on 60 individuals with mechanical LBP. Participants were randomly assigned to the control group (n=30) that received McKenzie exercises for 7 days or experimental group (n=30) that received KT application in addition to McKenzie exercises for 7 days. Pain measured by visual analogue scale, lumbar range of motion, and the disability measured by Oswestry Disability Index (ODI) were used as outcome measures. Pre and Post measurements were taken at baseline and after 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: McKenzie Exercises, Other: Kinesio Tape ApplicationThe control group will receive only McKenzie exercises for 7 days. |
| Experimental Group | Experimental | Other: Kinesio Tape ApplicationThe experimental group will receive Kinesio tape application in addition to McKenzie exercises for 7 days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with mechanical LBP by a physician
Key exclusion criteria (5 listed)
- Individuals with any structural or pathological changes (spondylitis, spondylolisthesis, cauda equina syndrome, lumbar canal stenosis) in lumbar spine on X-ray or MRI
- Individuals with or without neurological signs in the lower extremity suggestive upper motor or lower motor neuron involvement,
- Individuals with a history of trauma or any surgery in the region of back,
- Individuals with recent aggravation of symptoms,
- Individuals on a waiting list for spinal surgery or had a spinal surgery in the past 6 months
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 |
|---|---|---|
| McKenzie ExercisesMcKenzie exercises: The McKenzie set consists of 5 exercises. 1. Prone-lying 2. Prone-extension 3. Prone press ups 4. Progressive extension with pillows 5. Standing extension | Other | Control Group |
| Kinesio Tape ApplicationKinesio Tape (KT) application: Participants in the experimental group received additional taping using KT by an experience therapist with prior training in KT application. The tape was applied using the method proposed for the sacrospinalis muscle (Kase, 1996). Y-shaped tape was applied as shown in Figure 1. While the participant was in standing position, the origin of the Y-shaped tape was attached over the centre of the sacrum without stretching the tape and afterward subjects gradually bent forward. A 5-degree angle was maintained within the valley of the Y tape. The tape was changed on the fourth day | Other | Control Group, Experimental Group |
Primary outcome
Visual analogue scale (VAS)
Time frame: The pain was measured at baseline
Pain was measured using a 10 cm visual analogue scale (VAS). The participants placed a mark on the line that best represented their perception of pain at that instant. The VAS score was measured in cm from the left hand end of the line to the mark.
Visual analogue scale (VAS)
Time frame: The pain was measured at the end of intervention (7th day).
Pain was measured using a 10 cm visual analogue scale (VAS). The participants placed a mark on the line that best represented their perception of pain at that instant. The VAS score was measured in cm from the left hand end of the line to the mark.
2 secondary outcomes
The Oswestry Disability Index (ODI)
Time frame: The ODI was measured at study entry 2 minutes after the pain assesment.
The Oswestry Disability Index (ODI)
Time frame: The ODI was measured at the end of intervention (7th day) 2 minutes after the pain assesment.
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 24 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McKenzie Exercises and Kinesio Tape Application in people with Low Back Pain, run by Marmara University at 1 site 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 5 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Visual analogue scale (VAS) (time frame: The pain was measured at baseline). 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?
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 24 Jan 2022.