Low Back PainNCT05104957
Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain
A study testing Dynamic tape in people with Low Back Pain and Young Adult, run by John Paul II University in Biała Podlaska at 2 sites in Poland.
Trial summary
Lumbar spine pain syndromes are one of the most common pain conditions in our society. The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Low Back Pain, Young Adult, Therapy
- What is being tested?
- Dynamic tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesPoland
- Study dates
- 15 Nov 2021to 30 Mar 2022
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- participants' age between 18 and 30,
- the presence of pain in the lumbar region of the spine,
- participants who have not been using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
- no contraindications to the use of dynamic kinesiology taping patches,
- informed, written consent to participate in the study.
Who cannot join
- status of the post lumbar spine surgery,
- subjects who have had a spinal injury within 6 months prior to the start of the study,
- neoplastic diseases,
- congenital structural pathologies of the spine,
- allergy to the adhesive substance of kinesiology taping or paper patch,
- being a physiotherapy student.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Pope John Paul II State School Of Higher Education in Biała Podlaska
Biała Podlaska, 21-500
Laboratory of Pope John Paul II State School Of Higher Education in Biala Podlaska
Biała Podlaska
About this study
Official title: Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain in Subjects Under 30 Years of Age
Lumbar spine pain syndromes are one of the most common pain conditions in our society.
The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Today, this method is used in many fields of medicine. Its primary purpose is to support the musculoskeletal system by using various types of applications.
There is a lack of publications in the global literature on the effect of kinesiotaping of the external oblique muscles on lumbar spine pain. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
Read the detailed description
Back pain occurs in people of all ages, regardless of their job. Both blue-collar and white-collar workers are exposed to strain and pain in the lumbar spine. The presence of pain is also promoted by low physical activity, poor motor habits, as well as stress.
There are numerous factors affecting the quality of life in patients with lower back pain. These include degree of pain, physical fitness, individual factors, degree of social support, and a potential for adapting forces to match constantly changing conditions.
The contemporary functional model of lumbar spinal muscles divides them into local stabilizers, single-joint global stabilizers, and multi-joint global stabilizers. The abdominal external oblique muscles are classified as global stabilizers. They generate force to control range of motion and allow limitation of that range (eccentric control), and functionally control rotation in all movements, regardless of the load acting on the spine.
The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
- Conditions
- Low Back Pain, Young Adult, Therapy
- Being tested
- Dynamic tape, Sham tape
- 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.
Dynamic tapeOther
The experimental group will use a special dynamic patch made of cotton, coated with a hypoallergenic acrylic heat-activated adhesive arranged in sinusoidal-shaped layers. The tape will be applied using the muscle technique with a Y-shaped cut patch directly to the dried and non-greased skin. The application will be performed in a standing position, with the participant's lower extremities straight. The therapist will place the beginning of the tape (the base) on the participant's sacrum and then, asking them to bend 45 degrees forward, tape the tails of the tape along the spine on the extensor muscles of the lumbar region, without changing the tension of the tape, keeping the base in the initial position.
Sham tapeOther
In the control group, a plain paper patch will be used to conduct the study, which, like the dynamic patch, will be applied using the same form of tape cutting and the same application technique. The entire method of applying the patch will also take place in the participant's standing position with forward bending. The paper patch will be placed at the levels from the L3 segment to the sacrum, along the spine on the lumbar extensor muscles.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic tape | Experimental | Experimental group will use a special dynamic tape on the lumbar extensor muscles Receives: Other: Dynamic tape |
| Paper tape | Sham comparator | Control group will use a paper tape on the lumbar extensor muscles Receives: Other: Sham tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Measured: Visual analogue pain scale (VAS) will be carried out before the start of the therapy.
Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Measured: Visual analogue pain scale (VAS) will be carried out 4 days of therapy, immediately after its completion.
Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Measured: Visual analogue pain scale (VAS) will be carried out four weeks after the end of the treatment.
Secondary outcomes (2)
Modified Laitinen's pain questionnaire
The Laitinen questionnaire takes into account four indicators evaluated in a scale of 0 to 4: the intensity of pain, the frequency of its occurrence, the use of analgesic medications and limitation of the participant's motor activity. A research participant could be granted from 0 to 16 points, the maximum score meaning the highest level of pain.
Measured: Modified Laitinen's pain questionnaire will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
Oswestry Disability Index
Oswestry Disability Index takes into account ten indicators evaluated in a scale of 0 to 5. A research participant could be granted from 0 to 50 points, the minimum score meaning the highest level of disability.
Measured: Oswestry Disability Index will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start15 Nov 2021
- Primary completion29 Mar 2022
- Study completion30 Mar 2022
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.
- 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
- Model description
- The study participants will be randomly qualified (allocated via a computer program) to the two groups: A - dynamic tape, B - sham (paper) tape
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Paul II University in Biała Podlaska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamil Zaworski, Ph.D., Study chair, John Paul II University in Biała Podlaska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104957
- Sponsor's protocol ID
- PopeJohnPaulIIStateSchHigherE2
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 12 Apr 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 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain in Subjects Under 30 Years of Age
- ClinicalTrials.gov ID
- NCT05104957
- Acronym / sponsor ID
- PopeJohnPaulIIStateSchHigherE2
- Conditions
- Low Back Pain, Young Adult, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- John Paul II University in Biała PodlaskaUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 3 Nov 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.
Lumbar spine pain syndromes are one of the most common pain conditions in our society.
The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Today, this method is used in many fields of medicine. Its primary purpose is to support the musculoskeletal system by using various types of applications.
There is a lack of publications in the global literature on the effect of kinesiotaping of the external oblique muscles on lumbar spine pain. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
Detailed description
Back pain occurs in people of all ages, regardless of their job. Both blue-collar and white-collar workers are exposed to strain and pain in the lumbar spine. The presence of pain is also promoted by low physical activity, poor motor habits, as well as stress.
There are numerous factors affecting the quality of life in patients with lower back pain. These include degree of pain, physical fitness, individual factors, degree of social support, and a potential for adapting forces to match constantly changing conditions.
The contemporary functional model of lumbar spinal muscles divides them into local stabilizers, single-joint global stabilizers, and multi-joint global stabilizers. The abdominal external oblique muscles are classified as global stabilizers. They generate force to control range of motion and allow limitation of that range (eccentric control), and functionally control rotation in all movements, regardless of the load acting on the spine.
The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study participants will be randomly qualified (allocated via a computer program) to the two groups: A - dynamic tape, B - sham (paper) tape
| Arm | Type | Receives |
|---|---|---|
| Dynamic tape | Experimental | Other: Dynamic tapeExperimental group will use a special dynamic tape on the lumbar extensor muscles |
| Paper tape | Sham comparator | Other: Sham tapeControl group will use a paper tape on the lumbar extensor muscles |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- participants' age between 18 and 30,
- the presence of pain in the lumbar region of the spine,
- participants who have not been using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
- no contraindications to the use of dynamic kinesiology taping patches,
- informed, written consent to participate in the study.
Key exclusion criteria (6 listed)
- status of the post lumbar spine surgery,
- subjects who have had a spinal injury within 6 months prior to the start of the study,
- neoplastic diseases,
- congenital structural pathologies of the spine,
- allergy to the adhesive substance of kinesiology taping or paper patch,
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 |
|---|---|---|
| Dynamic tapeThe experimental group will use a special dynamic patch made of cotton, coated with a hypoallergenic acrylic heat-activated adhesive arranged in sinusoidal-shaped layers. The tape will be applied using the muscle technique with a Y-shaped cut patch directly to the dried and non-greased skin. The application will be performed in a standing position, with the participant's lower extremities straight. The therapist will place the beginning of the tape (the base) on the participant's sacrum and then, asking them to bend 45 degrees forward, tape the tails of the tape along the spine on the extensor muscles of the lumbar region, without changing the tension of the tape, keeping the base in the initial position. | Other | Dynamic tape |
| Sham tapeIn the control group, a plain paper patch will be used to conduct the study, which, like the dynamic patch, will be applied using the same form of tape cutting and the same application technique. The entire method of applying the patch will also take place in the participant's standing position with forward bending. The paper patch will be placed at the levels from the L3 segment to the sacrum, along the spine on the lumbar extensor muscles. | Other | Paper tape |
Primary outcome
Visual analogue scale of pain (VAS)
Time frame: Visual analogue pain scale (VAS) will be carried out before the start of the therapy.
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Visual analogue scale of pain (VAS)
Time frame: Visual analogue pain scale (VAS) will be carried out 4 days of therapy, immediately after its completion.
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Visual analogue scale of pain (VAS)
Time frame: Visual analogue pain scale (VAS) will be carried out four weeks after the end of the treatment.
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
2 secondary outcomes
Modified Laitinen's pain questionnaire
Time frame: Modified Laitinen's pain questionnaire will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
Oswestry Disability Index
Time frame: Oswestry Disability Index will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
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 12 Apr 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.
Kamil Zaworski, Ph.D. study chair
John Paul II University in Biała Podlaska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic tape in people with Low Back Pain and Young Adult, run by John Paul II University in Biała Podlaska at 2 sites in Poland.
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 6 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 12 Apr 2022. 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 Poland. 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?
Visual analogue scale of pain (VAS) (time frame: Visual analogue pain scale (VAS) will be carried out before the start of the therapy.). The study lists 3 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 12 Apr 2022.