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NCT06294132 · ClinicalTrials.gov registry record · NA
Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability
A NA study of Low Back Pain, sponsored by Ithaca College.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06294132 is a NA study of Low Back Pain that is actively recruiting participants, run by Ithaca College. The registered enrollment target is 40 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06294132, a NA study of Low Back Pain, is actively recruiting participants, sponsored by Ithaca College.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 therapist's 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 (NPR),Oswestry 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 subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's 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-L2,L2-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 manipulatio
Conditions Studied
Interventions
- PROCEDURE Lumbar Manipulation
- PROCEDURE Sham Lumbar Manipulation
Study Locations (1)
New York
- Ithaca College - Ithaca
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2024-10-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06294132
The ClinicalTrials.gov registry entry for NCT06294132 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower). The listed sponsor is Ithaca College, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Lumbar Manipulation is the first listed.
NCT06294132 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06294132 about?
NCT06294132 is a clinical study titled "Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability". 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...
What is the current status of trial NCT06294132?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-02-27. Estimated completion is 2024-10-28.
What conditions does trial NCT06294132 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT06294132?
The interventions under investigation include: Lumbar Manipulation (PROCEDURE), Sham Lumbar Manipulation (PROCEDURE).
Who is sponsoring clinical trial NCT06294132?
This trial is sponsored by Ithaca College, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06294132 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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