Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability - Trial NCT06294132

Timeline & Enrollment

Primary Outcome

Diagnostic Ultrasound

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.

ICD-10 Classifications