Clinical Trials Directory

Trials / Completed

CompletedNCT06277739

Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI

Brain Effect Mechanism of Spinal Manipulative Therapy on Lumbar Disc Herniation Analgesia Based on Multimodal Magnetic Resonance Imaging

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Zhou Xingchen · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The clinical symptoms of Lumbar Disc Herniation (LDH) can be effectively ameliorated through Spinal Manipulative Therapy (SMT), which is closely linked to the brain's pain-regulating mechanisms. Magnetic Resonance Imaging (MRI) offers an objective and visual means to study how the brain orchestrates the characteristics of analgesic effects. From the perspective of multimodal MRI, the investigators applied functional MRI (fMRI) and Magnetic Resonance Spectrum (MRS) techniques to comprehensively evaluate the characteristics of the effects of SMT on the brain region of LDH from the aspects of brain structure, brain function and brain metabolism. This multimodal MRI technique provides a biological basis for the clinical application of SMT in LDH.

Conditions

Interventions

TypeNameDescription
PROCEDURESpinal Manipulative TherapyThe participant was placed in a side-lying position facing the clinician with the more painful side facing upward. The clinician passively flexed the participant's hips and knees to induce lumbar spine flexion until they felt the spinous process of the affected lumbar vertebrae begin to move. Next, the clinician passively rotated the participant's torso opposite to the side they were lying on until they felt rotation in the vertebra above the suspected lesion. The clinician applied a rapid thrust to the shoulder (anterior to posterior force) and pelvis (posterior to anterior force) resulting in a rotation force couple on the hypomobile segment. If a cavitation (ie, an audible pop) occurred, the treatment was considered complete. If no cavitation was produced, the participant was repositioned and the manipulation was attempted again. A maximum of 2 attempts per side was permitted. If no cavitation was produced after the 4 attempts (ie, 2 per side), the treatment was considered complete.
OTHERSham Laser TreatmentThe laser manufacturer (MedX Health Corp) provided a MedX 1100 system that did not deliver any significant amount of light energy or heat but otherwise appeared operational to participants and clinicians. The sham laser was delivered over the painful region with the study participant positioned as described for spinal manipulation and spinal mobilization treatments.

Timeline

Start date
2022-06-01
Primary completion
2025-05-01
Completion
2025-05-01
First posted
2024-02-26
Last updated
2025-06-15

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06277739. Inclusion in this directory is not an endorsement.