Lumbar Disc HerniationNCT05940519
Short-Term Effects of Dynamic Taping in Patients With Lumbar Disc Herniation
A study testing Dynamic taping technique in people with Lumbar Disc Herniation and Acute Pain, run by NAİME ULUG.
Trial summary
Previous evidence has shown that kinesio tape application reduces pain levels and improves disability in patients with chronic low back pain due to lumbar disc herniation. However, it is not known, whether the dynamic taping can decrease back pain, improve endurance of paraspinal muscles, and improve functional… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lumbar Disc Herniation, Acute Pain
- What is being tested?
- Dynamic taping technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2023to 15 Aug 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with diagnose of lumbar disc herniation,
- self-reported activity pain due to lumbar disc herniation for at least the last 3 months,
- with pain severity equal to or greater than 3 on a numerical rating scale,
- patients with no skin irritation, sensitivities or allergies
Who cannot join
- Patients with spinal pathology, lumbar surgery, motor weakness, urinary or fecal incontinence due to lumbar disc herniation, cauda equina syndrome, pregnancy, neurological or rheumatological condition, dermatitis or pre-existing skin lesion over the taping area, and having dynamic taping allergies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short-Term Effects of Dynamic Taping on Pain, Pain Threshold, Endurance, Balance, Lumbar Joint Mobility And Functionality in Patients With Lumbar Disc Herniation
Previous evidence has shown that kinesio tape application reduces pain levels and improves disability in patients with chronic low back pain due to lumbar disc herniation. However, it is not known, whether the dynamic taping can decrease back pain, improve endurance of paraspinal muscles, and improve functional capacity in patients with lumbar disk herniation. The aim of the current study is to examine the acute effects of dynamic taping on pain, pain threshold, endurance, balance, lumbar joint mobility and functionality in patients with lumbar disc herniation.
Read the detailed description
The study will include 34 volunteer adult patients who have been diagnosed with lumbar disc herniation according to the physical examination and magnetic resonance imaging and have referred to the physiotherapy and rehabilitation service by a specialist physician. The patients will be divided into 2 groups as dynamic tape (n=17) and sham tape (n=17). Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.
The outcomes of the study will be analyzed by appropriate statistical methods.
- Conditions
- Lumbar Disc Herniation, Acute Pain
- Being tested
- Dynamic taping technique, Sham taping
- Keywords
- lumbar disc herniation, dynamic tape, acute pain
- Medical subject headings
- Intervertebral Disc Displacement, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic taping techniqueOther
The dynamic taping method as specified in the literature will be applied to the right and left lumbar paravertebral muscles in the dynamic taping group. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.
Sham tapingOther
Sham taping will be applied with a surgical patch while the patient is in a comfortable position without any technique or stretching.Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.
| Study group | Role | What they receive |
|---|---|---|
| dynamic tape group | Experimental | The dynamic tape group Receives: Other: Dynamic taping technique; Other: Sham taping |
| sham taping group | Sham comparator | The sham tape group Receives: Other: Dynamic taping technique; Other: Sham taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity evaluation
The severity of the pain will be measured with Numerical Rating Scale. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Measured: Up to one month
Pain threshold measurement
Pain threshold will be measured Jtech Commander digital algometer
Measured: Up to one month
Secondary outcomes (4)
The evaluation of lumbar muscle endurance
Modified Sorenson Test will be used
Measured: Up to one month
The evaluation of balance
Functional reach test will be used
Measured: Up to one month
Lumbar joint mobility
Universal goniometer will be used
Measured: Up to one month
Functional movement level
Timed up and go test will be used
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start12 Jul 2023 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- prospective randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NAİME ULUG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NAİME ULUG, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940519
- Sponsor's protocol ID
- E-59394181-604.01.02-22601
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of Dynamic Taping on Pain, Pain Threshold, Endurance, Balance, Lumbar Joint Mobility And Functionality in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05940519
- Acronym / sponsor ID
- E-59394181-604.01.02-22601
- Conditions
- Lumbar Disc Herniation, Acute Pain
- Keywords
- lumbar disc herniation, dynamic tape, acute pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- NAİME ULUGUniversity, hospital or other
- Study start
- 12 Jul 2023 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 11 Jul 2023 (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.
Previous evidence has shown that kinesio tape application reduces pain levels and improves disability in patients with chronic low back pain due to lumbar disc herniation. However, it is not known, whether the dynamic taping can decrease back pain, improve endurance of paraspinal muscles, and improve functional capacity in patients with lumbar disk herniation. The aim of the current study is to examine the acute effects of dynamic taping on pain, pain threshold, endurance, balance, lumbar joint mobility and functionality in patients with lumbar disc herniation.
Detailed description
The study will include 34 volunteer adult patients who have been diagnosed with lumbar disc herniation according to the physical examination and magnetic resonance imaging and have referred to the physiotherapy and rehabilitation service by a specialist physician. The patients will be divided into 2 groups as dynamic tape (n=17) and sham tape (n=17). Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.
The outcomes of the study will be analyzed by appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| dynamic tape group | Experimental | Other: Dynamic taping technique, Other: Sham tapingThe dynamic tape group |
| sham taping group | Sham comparator | Other: Dynamic taping technique, Other: Sham tapingThe sham tape group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with diagnose of lumbar disc herniation,
- self-reported activity pain due to lumbar disc herniation for at least the last 3 months,
- with pain severity equal to or greater than 3 on a numerical rating scale,
- patients with no skin irritation, sensitivities or allergies
Key exclusion criteria (1 listed)
- Patients with spinal pathology, lumbar surgery, motor weakness, urinary or fecal incontinence due to lumbar disc herniation, cauda equina syndrome, pregnancy, neurological or rheumatological condition, dermatitis or pre-existing skin lesion over the taping area, and having dynamic taping allergies
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 taping techniqueThe dynamic taping method as specified in the literature will be applied to the right and left lumbar paravertebral muscles in the dynamic taping group. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups. | Other | dynamic tape group, sham taping group |
| Sham tapingSham taping will be applied with a surgical patch while the patient is in a comfortable position without any technique or stretching.Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups. | Other | dynamic tape group, sham taping group |
Primary outcome
Pain severity evaluation
Time frame: Up to one month
The severity of the pain will be measured with Numerical Rating Scale. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Pain threshold measurement
Time frame: Up to one month
Pain threshold will be measured Jtech Commander digital algometer
4 secondary outcomes
The evaluation of lumbar muscle endurance
Time frame: Up to one month
The evaluation of balance
Time frame: Up to one month
Lumbar joint mobility
Time frame: Up to one month
Functional movement level
Time frame: Up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic taping technique in people with Lumbar Disc Herniation and Acute Pain, run by NAİME ULUG.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M.Fatih Adalı, Msc. (+905543298251, fzt.fadali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity evaluation (time frame: Up to one month). 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 12 Jul 2023.