Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294132
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-27
Brief Title:
Effect of Lumbar Manipulation on Intervertebral Motion Pain and Disability
Sponsor:
Ithaca College
Organization:
Ithaca College
Study Overview
Official Title:
Effect of Lumbar Manipulation on Intervertebral Motion Pain and Disability
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Purpose
There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation Also in question is the mechanism of improvement observed after spinal manipulation Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion This study aimed to determine the diagnostic accuracy of a physical therapists manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion pain and disability
Methods
Subjects will complete a Numeric Pain Rating Scale NPROswestry Disability Index ODI and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool They will be screened for contraindications to manipulation and neurological signs and symptoms Active forward bending will be quantified by measuring the distance of the subjects fingertips to the floor Two experienced physical therapists will evaluate the subjects lumbar intervertebral mobility They will identify the lumbar segment with the least motion or hypomobility The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer Edge II MSK ultrasound unit SonoSite Inc Bothell WA in the sidlying position with their trunk and hips flexed to end-range The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment L5-S1 L4-L5 L3-L2L2-L1 Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation The lumbar spine will be reimaged The ultrasound examiner will be blinded to the manipulation and the caliper measurements Finally subjects will be asked for their Global Rating of Change GROC and to actively bend forward to remeasure the distance of their fingertips to the floor One week later patients will receive an e-mail containing links to repeat the NPR GROC and ODI
There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation Also in question is the mechanism of improvement observed after spinal manipulation Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion This study aimed to determine the diagnostic accuracy of a physical therapists manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion pain and disability
Methods
Subjects will complete a Numeric Pain Rating Scale NPROswestry Disability Index ODI and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool They will be screened for contraindications to manipulation and neurological signs and symptoms Active forward bending will be quantified by measuring the distance of the subjects fingertips to the floor Two experienced physical therapists will evaluate the subjects lumbar intervertebral mobility They will identify the lumbar segment with the least motion or hypomobility The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer Edge II MSK ultrasound unit SonoSite Inc Bothell WA in the sidlying position with their trunk and hips flexed to end-range The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment L5-S1 L4-L5 L3-L2L2-L1 Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation The lumbar spine will be reimaged The ultrasound examiner will be blinded to the manipulation and the caliper measurements Finally subjects will be asked for their Global Rating of Change GROC and to actively bend forward to remeasure the distance of their fingertips to the floor One week later patients will receive an e-mail containing links to repeat the NPR GROC and ODI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None