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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05496387
Other study ID # 6
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 15, 2022
Est. completion date November 15, 2022

Study information

Verified date September 2022
Source Istinye University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low back pain (LBP) is a common symptom that can be a health problem in worldwide. Studies have shown that 70% to 80% of all people are affected at least once in their lives. Although it is common, the cause of the pain has often not been determined and is referred to as non-specific LBP. The lumbar range of motion decreases, trunk flexion is limited, postural control and muscular stiffness are affected in individuals with LBP. Recent studies have shown that people with LBP have altered nerve properties in the sciatic nerve. It was observed that the cross-sectional area of the sciatic nerve decreased and its stiffness increased. Peripheral nerve tissues are faced with great tension and compressive forces that occur in daily life activities and sports activities. To maintain the normal function of the nervous system, it must have the ability to resistance to tension, easy to slide in the environment it is in and withstand compressive forces. In case of not being able to resist the pressure exerted by surrounding tissues such as bone, tendon, muscle, fascia, there may be distortions in the shapes of neural structures. Neuromobilization, one of the manual therapy techniques, is used in impingement syndromes of peripheral nerves and neuropathies. Neuromobilization aims to regain the normal mechanical properties of the nerve by using limb movements, motion and position of the joint. There are two methods of neuromobilization techniques; sliding and tension. Sliding involves combinations of movements that lengthen the nerve bed in one joint and reduce the length of the nerve bed in the next joint, while tension is done by stretching both ends of the nerve bed. Neuromobilization structures the balance between the relative movements of the neural tissues and the surrounding mechanical interface, allows the reduction of internal pressure in the neural tissue, and thus optimum physiological functions are regulated. The mechanism of action of neuromobilization is thought to be to increase intraneural circulation, improve axoplasmic flow and connective tissue viscoelasticity, and reduce hypersensitive areas. Neuromobilization techniques are extensively used in clinical settings during the therapy of patients with sciatica, with favorable effects on pain and impairment. However, the mechanical implications of neuromobilization in human nerves are poorly understood. Two investigations that used SWE to measure sciatic nerve stiffness in healthy adults following prolonged slump positions came up with conflicting conclusions. It has been determined that there are different opinions on the effects of slump neuromobilizations in sciatic nerves. Considering that slump neuromobilization techniques are frequently used for therapeutic, it should be appropriate to determine their effects on the sciatic nerve.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 36
Est. completion date November 15, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: Diagnosis of nonspecific LBP Having pain for at least 3 months Exclusion Criteria: Obesity Pregnancy Specific disorders of the lumbar spine such as disc problems Spinal stenosis Having indication for surgery Any recent or old significant trauma of the lumbar region Any systemic inflammatory disease Having neurological problems Any forms of physiotherapy within 6 months before the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sciatic nerve neuromobilization techniques
Sciatic nerve neuromobilization techniques (tension and sliding) was applied to the dominant side lower extremities of all participants in the study. While the participant was trying to bring her chin closer to her chest by flexing her head and neck, she simultaneously brought her foot to dorsiflexion. After waiting 30 seconds in this tense position, the ankle, head and neck returned to neutral position and relaxed. 3 sets were repeated with 1 minute rest breaks. Sciatic nerve sliding was applied in the same starting position as tension. While the participants was trying to bring her chin closer to her chest by flexing her head and neck, she simultaneously brought her foot to plantar flexion.

Locations

Country Name City State
Turkey Istinye University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary SWE Imaging Longitudinal ultrasound SWE images of the sciatic nerve will be taken bilaterally with a linear array probe in the prone position. By selecting the largest area within the epineurium boundaries in the elastographic window, a rapid area of interest will be determined on the sciatic nerve in each clip. This approximation will be made for each frame to ensure that the area of interest is not affected by nerve movement throughout the maneuvers. The color pixels of each elastogram will be converted to SWV values using the appropriate scale (maximum 17.0 m/s) (15). 4 week
Secondary The Sit-and-Reach Test Flexibility of the back and legs will be assessed using the sit and lie down test. A specially designed box will be used for the test. The participant will sit in front of the 23 cm box with their knees bent and their legs together. The person has extended his arm as far as he can and will hold it there for two seconds. 4 week
Secondary The Straight Leg Raise (SLR) Test During the test, the participants will be placed in the supine position with their knees in full extension and the other knees in half flexion. He will be asked to try to stretch his hip by raising his leg up. The test will be terminated at the point where he feels pain and tension in the waist and hip. 4 week
Secondary The Vertical Jump Test During the counter move, participants stand with their feet shoulder-width apart, with equal weight distribution on both feet, and will make a mark at the highest point they can reach. Participants will then mark the highest point they can reach by jumping by bending their knees and ankles. The distance between these two marks will be measured in centimeters and recorded. 4 week
Secondary The 3-Step Forward Test Participants will prepare by bending one knee just behind the starting line and lifting the leg off the ground. Participants performed three jumping moves: jumping on the starting leg, stepping on the other leg, and a double jump. The distance between the starting line and the heel of the foot closest to the line was measured and will be recorded in centimeters. 4 week
Secondary The Flamingo Balance Test Participants will stand on the beam, balancing on one leg with bare feet; the other leg is flexed at the knee and the foot is kept close to the hip and the hands will be held on the pelvis. After a trial period of 1 minute, the person will do 3 trials with eyes open on both legs. 4 week
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