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Completed

NCT Number: NCT06277739

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must meet the diagnostic criteria for lumbar disc herniation, including protrusion types such as central, paracentral, far lateral, foraminal, and subarticular, with imaging findings that align with neurological localization.
  • The age range for participants is 18 to 65 years, encompassing any gender, and they must be right-handed.
  • Participants should be in the non-acute phase of the condition, experiencing mild to moderate pain and functional impairment, with the duration of symptoms exceeding 2 weeks.
  • Participants should have a Visual Analog Scale (VAS) score greater than 4 and Japanese Orthopaedic Association (JOA) scores less than 15.
  • Eligible participants must not have taken analgesics, neurotropic nutrition drugs, or sedatives in the past month and should not have undergone systemic treatment.
  • Participants should not have received spinal manipulation or other physical therapies in the past month.
  • Participants must voluntarily agree to participate in this study and have signed an informed consent form.

Exclusion criteria

  • Patients with concurrent internal medicine or gynecological conditions known to cause lower back pain, such as nephritis, urinary stones, gynecological inflammations, and uterine abnormalities.
  • Individuals with severe primary diseases impacting the cardiovascular, cerebrovascular, liver, or kidney systems.
  • Those with neurogenic functional disorders, psychiatric conditions, a history of significant head trauma, or a history of unconsciousness.
  • Individuals diagnosed with primary sciatica or dry sciatica.
  • Those with lumbar spondylolisthesis.
  • Patients suffering from lumbar tumors or tuberculosis.
  • Individuals with severe osteoporosis or localized skin lesions in the lumbar area.
  • Patients experiencing painful conditions beyond the lumbar region.
  • Those with diseases characterized by structural changes in the brain.
  • Individuals with impaired consciousness, severe visual or hearing impairments, speech disorders, or others who are unable to complete health assessments.
  • Individuals with dental implants, metal stents, or other elements that may compromise MRI imaging.
  • Those with a fear of MRI or other reasons that prevent undergoing MRI scans.
  • Patients diagnosed with lumbar disc herniation but who are asymptomatic.

Treatment and study plan

Spinal Manipulative Therapy

Procedure

The 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.

Sham laser treatment

Other

The 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.

Primary outcomes

  1. visual analogue scale (VAS)

    Time frame: up to one month

    Pain intensity was evaluated by means of a visual analogue scale (VAS) [10-point visual analogue scale: 0 = no pain; 10 = very severe pain].

  2. Japanese Orthopaedic Association Scores (JOA)

    Time frame: up to one months

    Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.

  3. Amplitude of Low-Frequency Fluctuation (ALFF)

    Time frame: up to one months

    The ALFF measures the activity of neurons in the brain that are not affected by external factors.

  4. Regional Homogeneity (ReHo)

    Time frame: up to one months

    The ReHo measures the consistency of the local functional activities of the brain's various regions.

  5. Functional Connectivity (FC)

    Time frame: up to one months

    The FC represents the strength Of functional connections between brain regions, and can reflect the temporal correlation between the Region Of Interest (ROI) and the whole brain networking function.

  6. Magnetic Resonance Spectrum （MRS）

    Time frame: up to one month

    The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.

Sponsors and collaborators

Lead sponsor

Zhou Xingchen

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2024
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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