- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940519
Short-Term Effects of Dynamic Taping in Patients With Lumbar Disc Herniation
Short-Term Effects of Dynamic Taping on Pain, Pain Threshold, Endurance, Balance, Lumbar Joint Mobility And Functionality in Patients With Lumbar Disc Herniation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: M.Fatih Adalı, Msc.
- Phone Number: +905543298251
- Email: fzt.fadali@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dynamic tape group
The dynamic tape group
|
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 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.
|
Sham Comparator: sham taping group
The sham tape group
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
Up to one month
|
Pain threshold measurement
Time Frame: Up to one month
|
Pain threshold will be measured Jtech Commander digital algometer
|
Up to one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The evaluation of lumbar muscle endurance
Time Frame: Up to one month
|
Modified Sorenson Test will be used
|
Up to one month
|
The evaluation of balance
Time Frame: Up to one month
|
Functional reach test will be used
|
Up to one month
|
Lumbar joint mobility
Time Frame: Up to one month
|
Universal goniometer will be used
|
Up to one month
|
Functional movement level
Time Frame: Up to one month
|
Timed up and go test will be used
|
Up to one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-59394181-604.01.02-22601
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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