NCT05313217

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

March 28, 2022

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knee Extension Angle

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

    single testing session at enrollment

Secondary Outcomes (2)

  • EMG activity, biceps femoris

    single session at enrollment

  • qualitative data- extent, nature, and intensity of pain

    single testing session at enrollment

Study Arms (1)

neural tension testing

EXPERIMENTAL

All participants in this arm will undergo four tests: KEA, SLR, Slump, and Extended Slump

Diagnostic Test: Knee extension angleDiagnostic Test: Straight Leg RaiseDiagnostic Test: Slump TestDiagnostic Test: Extended slump test

Interventions

Knee extension angleDIAGNOSTIC_TEST

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)

Also known as: KEA
neural tension testing
Straight Leg RaiseDIAGNOSTIC_TEST

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)

Also known as: SLR
neural tension testing
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)

neural tension testing
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)

neural tension testing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

Related Publications (1)

  • 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. 2025 Aug 21:10538127251370575. doi: 10.1177/10538127251370575. Online ahead of print.

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Swanson, PT, DSc

    University of Hartford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental single group laboratory study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 6, 2022

Study Start

March 28, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Data will be shared upon request following completion of this study

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Following study completion and manuscript submission
Access Criteria
upon request

Locations