Spine Position and Neural Sensitivity
Primary Purpose
Sciatic Nerve, Postural Lordosis, Nerve Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Knee extension angle
Straight Leg Raise
Slump Test
Extended slump test
Sponsored by
About this trial
This is an interventional basic science trial for Sciatic Nerve
Eligibility Criteria
Inclusion Criteria:
- healthy individuals between the ages of 18 and 65 without low back pain.
Exclusion Criteria:
- 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
- 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)
Sites / Locations
- University of Hartford
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neural tension testing
Arm Description
All participants in this arm will undergo four tests: KEA, SLR, Slump, and Extended Slump
Outcomes
Primary Outcome Measures
Knee Extension Angle
A measurement of the degree of knee extension achieved during the KEA, Slump, and extended slump tests
Secondary Outcome Measures
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05313217
Brief Title
Spine Position and Neural Sensitivity
Official Title
The Influence of Spine Position on Measures of Lower Extremity Neural Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hartford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatic Nerve, Postural Lordosis, Nerve Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental single group laboratory study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neural tension testing
Arm Type
Experimental
Arm Description
All participants in this arm will undergo four tests: KEA, SLR, Slump, and Extended Slump
Intervention Type
Diagnostic Test
Intervention Name(s)
Knee extension angle
Other Intervention Name(s)
KEA
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Straight Leg Raise
Other Intervention Name(s)
SLR
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Slump Test
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Extended slump test
Intervention Description
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)
Primary Outcome Measure Information:
Title
Knee Extension Angle
Description
A measurement of the degree of knee extension achieved during the KEA, Slump, and extended slump tests
Time Frame
single testing session at enrollment
Secondary Outcome Measure Information:
Title
EMG activity, biceps femoris
Description
surface EMG activity of the biceps femoris during KEA, SLR, slump, and extended slump referenced to hamstring maximal voluntary isometric contraction
Time Frame
single session at enrollment
Title
qualitative data- extent, nature, and intensity of pain
Description
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)
Time Frame
single testing session at enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy individuals between the ages of 18 and 65 without low back pain.
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Swanson, PT, DSc
Organizational Affiliation
University of Hartford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hartford
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared upon request following completion of this study
IPD Sharing Time Frame
Following study completion and manuscript submission
IPD Sharing Access Criteria
upon request
Learn more about this trial
Spine Position and Neural Sensitivity
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