NCT06294132

Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ithaca College · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Lumbar Manipulation	The participant lies on the right side. The right leg is straightened at the knee. The left knee is flexed to the level to be manipulated, and the left foot is placed behind the right lower leg. The caregiver introduces rotation of the participant's upper body down to the level to be manipulated. The caregiver then takes up an axillary hold. The caregiver places his right forearm in the region between the gluteus medius and maximus. The caregiver then rolls the participant towards them. Prior to thrusting, the caregiver applies a slight overpressure and holds the position for 10 seconds. If the participant does not experience any adverse effects, over-pressure is released, and the restrictive barrier re=engaged. The caregiver applies a HVLA thrust against the participant's buttocks by dropping their body. If a cavitation "pop" is not heard the first time, a second attempt is made. The procedure is repeated on the opposite side.
PROCEDURE	Sham Lumbar Manipulation	The participant lies on the right side. The right leg is straightened at the knee. The left knee is flexed SLIGHTLY, and the left foot is placed behind the right lower leg. The caregiver DOES NOT introduce rotation of the participant's upper body down to the level to be manipulated. The caregiver then takes up an axillary hold. The caregiver places his right forearm in the region between the gluteus medius and maximus. The caregiver DOES NOT roll the participant towards them. Prior to thrusting, the caregiver applies a slight overpressure and holds the position for 10 seconds. If the participant does not experience any adverse effects, over-pressure is released, and the restrictive barrier re=engaged. The caregiver applies a HVLA thrust against the participant's buttocks by dropping their body. NO ROTATION OCCURS IN THE SPINE. The procedure is repeated on the opposite side.

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-10-21
• Completion: 2024-10-28
• First posted: 2024-03-05
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States