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Sciatic NerveNCT05313217

Spine Position and Neural Sensitivity

A study testing Knee extension angle, Straight Leg Raise and Slump Test in people with Sciatic Nerve and Postural Lordosis, run by University of Hartford at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to see if there is a relationship between the tightness of the hamstring muscles (muscles on the back of the thighs), reported sensations related to stretch of the nerves of the lower extremity, and different positions of participants' backs. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sciatic Nerve, Postural Lordosis, Nerve Pain
What is being tested?
Knee extension angle, Straight Leg Raise and Slump Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
28 Mar 2022to 31 Jul 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • healthy individuals between the ages of 18 and 65 without low back pain.

Who cannot join

  • Known previous diagnoses of sciatica or disc herniation
  • Diagnosis of scoliosis
  • History of pain in the low back or back of the leg
  • History of back surgeries
  • Any recent hamstring injuries
  • Any recent fractures
Show all 20Show fewer
  • History of osteoporosis
  • Have feeling of pins and needles down the leg
  • Have a known nervous system disorder
  • Have a known systemic inflammatory condition
  • Have Rheumatoid Arthritis
  • Known history of cardiovascular issues
  • Have a known connective tissue disorder
  • Bowel/bladder issues
  • Are or may be pregnant
  • Type 1 or type 2 diabetes mellitus
  • Active/history of cancer
  • Allergy to adhesives
  • Are actively involved in a lawsuit regarding personal bodily injury or receiving workman's compensation
  • Currently taking/have recently taken antibiotics known as fluoroquinolones (ie. Cipro, Levaquin, Noroxin)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Hartford

    West Hartford, Connecticut, 06117

Other trials in United States

About this study

Official title: The Influence of Spine Position on Measures of Lower Extremity Neural Sensitivity

The purpose of this research study is to see if there is a relationship between the tightness of the hamstring muscles (muscles on the back of the thighs), reported sensations related to stretch of the nerves of the lower extremity, and different positions of participants' backs. We will investigate the qualitative differences as provided verbally by participants (sensation felt at maximum knee extension angle) and quantitative differences as provided by surface electromyographic (EMG) measurements of hamstring activity and inclinometer measures of the knee angle.

Read the detailed description

The Slump Test, introduced by Maitland in 1978, has been a clinical staple for determining adverse neural tension or altered neurodynamics and neurosensitivity related to intradiscal derangement or stenotic narrowing of the lumbar spine. The slump test is a highly reliable, common clinical tool used to assess neural tissue mechanosensitivity in patients with both spinal and lower limb pain. However, it is unclear if the slump test can be used to differentiate between those with true adverse neural tension compared to those with neurosensitivity due to compression of the neuroforaminal interface. The positioning of the slump test places maximal tension on the neural tissues both caudally and cranially, either reducing knee extension angle (KEA) in the affected side as opposed to the unaffected side, provoking radicular symptoms, or both. Hall's research found that there was mechanical activity in the hamstring muscles that came on with neural tension testing. This finding can be used to objectively assess when a participant is at their peak tolerable limit of neural tension in specific trunk positions during the slump test. Observation and clinical experience suggest there may be a subset of individuals who have increased neural tension in the slump test during spinal extension (shortening of the nerves) as opposed to flexion (stretch of the nerves). To date, there has been little research that has objectively demonstrated how trunk position affects neural tension during the slump test. Our research aims to determine if there is a difference in patient reported symptoms and hamstring activity between trunk flexion and extension during the slump test with healthy, younger individuals with no recent history of low back pain (LBP) or related symptoms. We expect to find a difference in range of motion (ROM), symptoms, and hamstring activity when the slump test is done in spinal flexion as opposed to spinal extension. This research will help to establish the prevalence of greater sensitivity in the extended vs flexed posture and establish a normative set of symptoms as described by healthy individuals.

Being tested
Knee extension angle, Straight Leg Raise, Slump Test, Extended slump test
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knee extension angleDiagnostic test

    Also called KEA

    Knee Extension Angle (KEA):

    • This test will be administered with an ankle-foot orthosis (AFO) maintaining the participants ankle in neutral.
    • The participant will lie supine on the examination table with the contralateral lower extremity (LE) stabilized on the support surface using a mobilization strap.
    • The hip of the lower being examined will be flexed to 90 degrees.
    • The participant will then actively straighten their lower leg while maintaining upper leg in same position
    • Once the participant feels they are at maximal knee extension (patient instructed to straighten leg as far as what is comfortable), the angle will be measured with iPhone Inclinometer.
    • Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)
  • Straight Leg RaiseDiagnostic test

    Also called SLR

    Straight Leg Raise (SLR):

    • Position the participant in supine on the plinth with knees extended and L LE strapped to the plinth
    • The participant will keep the AFO donned on the R distal ankle to keep the ankle in neutral position.
    • A researcher will passively lift the participant's right leg moving at a slow but consistent pace of approximately 15 degrees per second, while keeping it straight until a significant resistance is detected or the participant reports a production of symptoms, whichever occurs first.
    • Measurement of the SLR angle will be assessed with iPhone inclinometer.
    • Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)
  • Slump TestDiagnostic test

    Slump Test Procedure:

    • Participant will be instructed to sit upright with their legs over the edge of table
    • AFO remains on R leg
    • Participant will sequentially flex trunk, look down at the floor
    • Participant will extend R knee until symptoms are felt. Measure of angle with iPhone inclinometer placed at superior aspect of medial malleolus
    • Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)
  • Extended slump testDiagnostic test

    Extended Slump Procedure:

    • Participant will be instructed to sit upright with their legs over the edge of table
    • AFO remains on R leg
    • Participant is asked to arch their lower back into maximal extension in sitting, stabilized to research bench to maintain hyper-lordosis posture.
    • The participant is asked first flex cervical spine, then to extend their knee until it reaches full ROM or symptoms are felt that limit ROM.
    • Knee extension ROM is assessed with iPhone inclinometer at superior aspect of medial malleolus.
    • Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)
Study groups in NCT05313217
Study groupRoleWhat they receive
neural tension testingExperimentalAll participants in this arm will undergo four tests: KEA, SLR, Slump, and Extended Slump
Receives: Diagnostic Test: Knee extension angle; Diagnostic Test: Straight Leg Raise; Diagnostic Test: Slump Test; Diagnostic Test: Extended slump test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee Extension Angle

    A measurement of the degree of knee extension achieved during the KEA, Slump, and extended slump tests

    Measured: single testing session at enrollment

Secondary outcomes (2)
  1. EMG activity, biceps femoris

    surface EMG activity of the biceps femoris during KEA, SLR, slump, and extended slump referenced to hamstring maximal voluntary isometric contraction

    Measured: single session at enrollment

  2. qualitative data- extent, nature, and intensity of pain

    for each test, the most distal extent of symptoms and intensity on the 11 point numeric pain rating scale will be collected. Participants will be asked to describe the nature of the symptoms experienced during the test (e.g. stretch, pain, pull, tingle, etc)

    Measured: single testing session at enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start28 Mar 2022
  3. Primary completion31 Jul 2022
  4. Study completion31 Jul 2022

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Quasi-experimental single group laboratory study
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05313217
Sponsor's protocol ID
PRO20220124
Status last verified
May 2023
First submitted
28 Mar 2022
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared upon request following completion of this study

Publications

  • Swanson B, McCarthy J, Clark E, Norman O, Wilson O. The influence of spine position on measures of lower extremity neural sensitivity. J Back Musculoskelet Rehabil. 2026 Jan;39(1):266-275. doi: 10.1177/10538127251370575. Epub 2025 Aug 21.

    PubMed 40836858

Questions about this trial

What is this clinical trial studying?

A study testing Knee extension angle, Straight Leg Raise and Slump Test in people with Sciatic Nerve and Postural Lordosis, run by University of Hartford at 1 site in United States.

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 20 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 10 May 2023. 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 United States. 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. 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?

Knee Extension Angle (time frame: single testing session at enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05313217, which also lists 1 linked publication.

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 10 May 2023.

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