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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05940519
Other study ID # E-59394181-604.01.02-22601
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 12, 2023
Est. completion date August 15, 2023

Study information

Verified date July 2023
Source Atilim University
Contact M.Fatih Adali, Msc.
Phone +905543298251
Email fzt.fadali@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Intervention

Other:
Dynamic taping technique
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
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
NAIME ULUG

Outcome

Type Measure Description Time frame Safety issue
Primary 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". Up to one month
Primary Pain threshold measurement Pain threshold will be measured Jtech Commander digital algometer Up to one month
Secondary The evaluation of lumbar muscle endurance Modified Sorenson Test will be used Up to one month
Secondary The evaluation of balance Functional reach test will be used Up to one month
Secondary Lumbar joint mobility Universal goniometer will be used Up to one month
Secondary Functional movement level Timed up and go test will be used Up to one month
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