Chronic Back PainNCT05167214
The Acute Effect Of Different Kinesiological Tape
A study testing The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain in people with Chronic Back Pain, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the acute effects of different kinesiology tapes on pain, functional performance and trunk endurance in young adults with chronic low back pain. Seventy young adults with chronic low back pain between the ages of 18-40 were included in our study. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Back Pain
- What is being tested?
- The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 10 May 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18-40 who accept participating in the research,
- low back pain for at least 3 months,
- have no perception problems
- can cope well,
- individuals who regularly come to the controls and evaluations of the physical therapy program.
Who cannot join
- undergone spinal surgery,
- have complain of low back pain due to inflammatory, tumoral, metabolic cause, orthopedic (pes planus, genu varum, genu valgum, scoliosis, etc.) or neurological (Multiple Sclerosis, Stroke, etc.) problems that prevent treatment, spine or lower back pain.
- have extremity surgery,
- have another musculoskeletal disorder affecting the lower extremity,
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain
This study aims to compare the acute effects of different kinesiology tapes on pain, functional performance and trunk endurance in young adults with chronic low back pain. Seventy young adults with chronic low back pain between the ages of 18-40 were included in our study. The individuals included in our study were divided into two groups by a simple randomization method. Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group. The demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance.
Read the detailed description
Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group. The demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance.
- Conditions
- Chronic Back Pain
- Being tested
- The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain
- Keywords
- Kinesiology Taping, Visual Pain Scale, Oswestry, Chronic Low Back Pain, Functional Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back PainDevice
The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain
| Study group | Role | What they receive |
|---|---|---|
| Star tape | Experimental | Group 1 ( n=35) was applied with the star technique. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance. Individuals in both groups were told to continue with their daily lives while on the tapes. It was stated that the bands should stay on the applied area for 4 days, that they can have a bath while the bands are on, and that if the bands are uncomfortable or excessive itching on the skin, the individuals can remove the bandage with an oily solution. No itching, redness, or allergic reactions was observed in either group. Receives: Device: The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain |
| I Tape | Placebo comparator | Group 2 (n=35) was applied in the form of I tape. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance. Individuals in both groups were told to continue with their daily lives while on the tapes. It was stated that the bands should stay on the applied area for 4 days, that they can have a bath while the bands are on, and that if the bands are uncomfortable or excessive itching on the skin, the individuals can remove the bandage with an oily solution. No itching, redness, or allergic reactions was observed in either group. Receives: Device: The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiological Tape Application
The individuals included in our study were divided into two groups by a simple randomization method. Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group.
Measured: 4 days
Secondary outcomes (5)
Visual Analogue Scale
Patients were asked to mark the pain they felt on a 10 cm scale between '0' (I have no pain) and '10' (I have unbearable pain), the distance between the marked point and the starting point was measured and recorded as data.
Measured: 4 days
Oswestry Scale
The Turkish version of the Oswestry Scale was applied to individuals to measure the low back pain disability level of the individuals. The study on the validity of the questionnaire was conducted by Yakut et al. In this scale, there are 10 questions evaluating various activities of daily living and 6 options for each question with a score between 0 and 5. 0-4 points as no disability, 5-14 points as mild, 15-24 points as moderate, 25-34 points as severe and 35-50 points as complete functional disability. The lowest score obtained from the scale is 0, and the highest score is 50. A score of 50 indicates the maximum level of functional disability.
Measured: 4 days
Lumbar Flexion Repeat Speed Test
To evaluate functional performance. Before starting the test, warm-up flexion was performed 3 times, and the individual was asked to bend forward 10 times as fast as he could, while standing and both heels together, and to straighten as fast as he could again. The chronometer was started with the start command, the chronometer was stopped after 10 consecutive flexion and extension were completed, and the elapsed time was recorded in seconds.
Measured: 4 days
Sit-and-Stand Test
To evaluate functional performance is the Sit-Up test (OKHT). After sitting on a chair, the individual was asked to get up and sit down as fast as he could 5 times, the chronometer was started with the start command, and the elapsed time was recorded in seconds after the last sitting was completed.
Measured: 4 days
Biering Sorenson Test
to assess the trunk endurance. Trunk Extensor Muscle Endurance (Biering-Sorensen Test): The individual was prone placed by hanging from the bed from the anterior superior of the spina iliaca, and was fixed at the gastrocnemius muscle level. He was asked to keep his torso parallel to the ground by clasping his hands on the chest. The time that parallelism was maintained was recorded.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start15 Jan 2021
- Primary completion25 Mar 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Principal investigator, mustafa gulsen, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167214
- Sponsor's protocol ID
- BaskentUU
- Status last verified
- Dec 2021
- First submitted
- 19 Oct 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain
- ClinicalTrials.gov ID
- NCT05167214
- Acronym / sponsor ID
- BaskentUU
- Conditions
- Chronic Back Pain
- Keywords
- Kinesiology Taping, Visual Pain Scale, Oswestry, Chronic Low Back Pain, Functional Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 22 Dec 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.
This study aims to compare the acute effects of different kinesiology tapes on pain, functional performance and trunk endurance in young adults with chronic low back pain. Seventy young adults with chronic low back pain between the ages of 18-40 were included in our study. The individuals included in our study were divided into two groups by a simple randomization method. Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group. The demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance.
Detailed description
Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group. The demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Star tape | Experimental | Device: The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back PainGroup 1 ( n=35) was applied with the star technique. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance. Individuals in both groups were told to continue with their daily lives while on the tapes. It was stated that the bands should stay on the applied area for 4 days, that they can have a bath while the bands are on, and that if the bands are uncomfortable or excessive itching on the skin, the individuals can remove the bandage with an oily solution. No itching, redness, or allergic reactions was observed in either group. |
| I Tape | Placebo comparator | Device: The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back PainGroup 2 (n=35) was applied in the form of I tape. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance. Individuals in both groups were told to continue with their daily lives while on the tapes. It was stated that the bands should stay on the applied area for 4 days, that they can have a bath while the bands are on, and that if the bands are uncomfortable or excessive itching on the skin, the individuals can remove the bandage with an oily solution. No itching, redness, or allergic reactions was observed in either group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between the ages of 18-40 who accept participating in the research,
- low back pain for at least 3 months,
- have no perception problems
- can cope well,
- individuals who regularly come to the controls and evaluations of the physical therapy program.
Key exclusion criteria (5 listed)
- undergone spinal surgery,
- have complain of low back pain due to inflammatory, tumoral, metabolic cause, orthopedic (pes planus, genu varum, genu valgum, scoliosis, etc.) or neurological (Multiple Sclerosis, Stroke, etc.) problems that prevent treatment, spine or lower back pain.
- have extremity surgery,
- have another musculoskeletal disorder affecting the lower extremity,
- pregnancy
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 |
|---|---|---|
| The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back PainThe Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain | Device | I Tape, Star tape |
Primary outcome
Kinesiological Tape Application
Time frame: 4 days
The individuals included in our study were divided into two groups by a simple randomization method. Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group.
5 secondary outcomes
Visual Analogue Scale
Time frame: 4 days
Oswestry Scale
Time frame: 4 days
Lumbar Flexion Repeat Speed Test
Time frame: 4 days
Sit-and-Stand Test
Time frame: 4 days
Biering Sorenson Test
Time frame: 4 days
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 22 Dec 2021.
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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 The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain in people with Chronic Back Pain, run by Baskent 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 5 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 22 Dec 2021. 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. 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?
Kinesiological Tape Application (time frame: 4 days). 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 22 Dec 2021.