NeuromobılızatıonNCT05496387
Effect of Neuromobılızatıon on Stiffness of Scıatıc Nerve
A study testing Sciatic nerve neuromobilization techniques in people with Neuromobılızatıon and Stiffness, run by Istinye University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Neuromobılızatıon, Stiffness, Scıatıc Nerve
- What is being tested?
- Sciatic nerve neuromobilization techniques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 15 Nov 2022
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of nonspecific LBP Having pain for at least 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuromobılızatıon on Stiffness of Scıatıc Nerve in Patients With Nonspecific Low Back Pain: Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Neuromobılızatıon, Stiffness, Scıatıc Nerve, Nonspecific Low Back Pain
- Being tested
- Sciatic nerve neuromobilization techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic nerve neuromobilization techniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group One | Experimental | Sciatic nerve neuromobilization techniques (tension) was applied to the dominant side lower extremities of all participants in the study. Receives: 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. Receives: Other: Sciatic nerve neuromobilization techniques |
| Control Group | Sham comparator | No application was applied to the sham group Receives: Other: Sciatic nerve neuromobilization techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 week
Secondary outcomes (5)
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.
Measured: 4 week
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.
Measured: 4 week
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.
Measured: 4 week
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.
Measured: 4 week
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.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start15 Oct 2022
- Primary completion15 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromobılızatıonStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- A prospective, randomized, controlled, double-blinded study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496387
- Sponsor's protocol ID
- 6
- Status last verified
- Apr 2025
- First submitted
- 9 Aug 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromobılızatıon on Stiffness of Scıatıc Nerve in Patients With Nonspecific Low Back Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05496387
- Acronym / sponsor ID
- 6
- Conditions
- Neuromobılızatıon, Stiffness, Scıatıc Nerve, Nonspecific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 11 Aug 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, randomized, controlled, double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Study Group One | Experimental | Other: Sciatic nerve neuromobilization techniquesSciatic nerve neuromobilization techniques (tension) was applied to the dominant side lower extremities of all participants in the study. |
| Study Group Two | Experimental | Other: Sciatic nerve neuromobilization techniquesSciatic nerve neuromobilization techniques (sliding) was applied to the dominant side lower extremities of all participants in the study. |
| Control Group | Sham comparator | Other: Sciatic nerve neuromobilization techniquesNo application was applied to the sham group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of nonspecific LBP Having pain for at least 3 months
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Sciatic nerve neuromobilization techniquesSciatic 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. | Other | Control Group, Study Group One, Study Group Two |
Primary outcome
SWE Imaging
Time frame: 4 week
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).
5 secondary outcomes
The Sit-and-Reach Test
Time frame: 4 week
The Straight Leg Raise (SLR) Test
Time frame: 4 week
The Vertical Jump Test
Time frame: 4 week
The 3-Step Forward Test
Time frame: 4 week
The Flamingo Balance Test
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sciatic nerve neuromobilization techniques in people with Neuromobılızatıon and Stiffness, run by Istinye University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SWE Imaging (time frame: 4 week). 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 15 Apr 2025.