NCT05496387

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

August 9, 2022

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The Sit-and-Reach Test

    4 week

  • The Straight Leg Raise (SLR) Test

    4 week

  • The Vertical Jump Test

    4 week

  • The 3-Step Forward Test

    4 week

  • The Flamingo Balance Test

    4 week

Study Arms (3)

Study Group One

EXPERIMENTAL

Sciatic nerve neuromobilization techniques (tension) was applied to the dominant side lower extremities of all participants in the study.

Other: Sciatic nerve neuromobilization techniques

Study Group Two

EXPERIMENTAL

Sciatic nerve neuromobilization techniques (sliding) was applied to the dominant side lower extremities of all participants in the study.

Other: Sciatic nerve neuromobilization techniques

Control Group

SHAM COMPARATOR

No application was applied to the sham group

Other: Sciatic nerve neuromobilization techniques

Interventions

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.

Control GroupStudy Group OneStudy Group Two

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of nonspecific LBP Having pain for at least 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, 34000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator did not collect pre-and post- neuromobilization techniques data and the patients were not aware of whether they had been allocated to tension or sliding group. Participants' evaluation and interventions were performed by different investigator. Participants were trained at different places.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, randomized, controlled, double-blinded study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

October 15, 2022

Primary Completion

October 15, 2022

Study Completion

November 15, 2022

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations