Lumbar Disc HerniationNCT06277739
Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI
A study testing Spinal Manipulative Therapy in people with Lumbar Disc Herniation, run by Zhou Xingchen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Spinal Manipulative Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053
About this study
Official title: Brain Effect Mechanism of Spinal Manipulative Therapy on Lumbar Disc Herniation Analgesia Based on Multimodal Magnetic Resonance Imaging
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
- Lumbar Disc Herniation
- Being tested
- Spinal Manipulative Therapy, Sham Laser Treatment
- Keywords
- Lumbar Disc Herniation, Spinal Manipulative Therapy, MRI
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manipulative TherapyProcedure or surgery
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 TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group1 (Spinal Manipulation Therapy) | Experimental | 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. Receives: Procedure: Spinal Manipulative Therapy |
| Group2 Sham Laser Treatment) | Placebo comparator | 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. Receives: Other: Sham Laser Treatment |
| Group3 (healthy controls) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
Pain intensity was evaluated by means of a visual analogue scale (VAS) [10-point visual analogue scale: 0 = no pain; 10 = very severe pain].
Measured: up to one month
Japanese Orthopaedic Association Scores (JOA)
Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.
Measured: up to one months
Amplitude of Low-Frequency Fluctuation (ALFF)
The ALFF measures the activity of neurons in the brain that are not affected by external factors.
Measured: up to one months
Regional Homogeneity (ReHo)
The ReHo measures the consistency of the local functional activities of the brain's various regions.
Measured: up to one months
Functional Connectivity (FC)
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.
Measured: up to one months
Magnetic Resonance Spectrum （MRS）
The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jun 2022
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhou Xingchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Xingchen, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Zhi-zhen Lv, Ph.D., Study director, The Third School of Clinical Medicine, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277739
- Sponsor's protocol ID
- 20220117020315695
- Status last verified
- Jun 2025
- First submitted
- 14 Feb 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhou XC, Wu S, Wang KZ, Chen LH, Wei ZC, Li T, Hua ZH, Xia Q, Lyu ZZ, Lyu LJ. Impact of Spinal Manipulative Therapy on Brain Function and Pain Alleviation in Lumbar Disc Herniation: A Resting-State fMRI Study. Chin J Integr Med. 2025 Feb;31(2):108-117. doi: 10.1007/s11655-024-4205-7. Epub 2024 Dec 21.
PubMed 39707137
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Effect Mechanism of Spinal Manipulative Therapy on Lumbar Disc Herniation Analgesia Based on Multimodal Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06277739
- Acronym / sponsor ID
- 20220117020315695
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar Disc Herniation, Spinal Manipulative Therapy, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zhou XingchenUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 (Spinal Manipulation Therapy) | Experimental | Procedure: Spinal 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. |
| Group2 Sham Laser Treatment) | Placebo comparator | Other: Sham 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. |
| Group3 (healthy controls) | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal 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. | Procedure or surgery | Group1 (Spinal Manipulation Therapy) |
| Sham 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. | Other | Group2 Sham Laser Treatment) |
Primary outcome
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].
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 39707137Zhou XC, Wu S, Wang KZ, Chen LH, Wei ZC, Li T, Hua ZH, Xia Q, Lyu ZZ, Lyu LJ. Impact of Spinal Manipulative Therapy on Brain Function and Pain Alleviation in Lumbar Disc Herniation: A Resting-State fMRI Study. Chin J Integr Med. 2025 Feb;31(2):108-117. doi: 10.1007/s11655-024-4205-7. Epub 2024 Dec 21.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-zhen Lv, Ph.D. study director
The Third School of Clinical Medicine, Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulative Therapy in people with Lumbar Disc Herniation, run by Zhou Xingchen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) (time frame: up to one month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06277739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.