Lumbar Disc HerniationNCT05613179
Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI
A study testing Group1 (lever positioning manipulation) in people with Lumbar Disc Herniation and Multimodal Brain Function, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
In order to further investigate the key brain targets and central response mechanism characteristics of analgesia, the dominant disease of LDH was taken as the object of this study, which was divided into operation group, comfort group and healthy subjects group. 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, Multimodal Brain Function, Analgesia Mechanism
- What is being tested?
- Group1 (lever positioning manipulation)
- 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 Sep 2021to 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
- patients suffering from low back pain and/or radicular leg pain;
- persistent pain for at least six months that was nonresponsive to conservative treatments;
- at least one epidural or facet joint corticosteroid injection in the last past year without pain relief or with an improvement in pain of less than two months.
- Lumbar protrusion level discopathy on MRI corresponding to the level of pain.
- No interventional pain treatment was applied within the last three months and patients needed a pain score equal or greater than four on the visual analogic scale (VAS).
- -
Who cannot join
- 1.patients with motor deficits, systemic infection, coagulation disorders, pregnancy； 2.VAS pain score lower than four； 3.Patients with any other condition that prevents an MRI scan from being performed.
- -
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
In order to further investigate the key brain targets and central response mechanism characteristics of analgesia, the dominant disease of LDH was taken as the object of this study, which was divided into operation group, comfort group and healthy subjects group. Firstly, DTI probabilistic tracking method was used to detect the changes of the brain white matter in each group. Then, the low-frequency amplitude (mfalff) and local consistency (ReHo) of each group were compared by fMRI scanning imaging technology, and the features of local brain functional connectivity (FC) of pain matrix related brain regions as seed points were analyzed. Finally, MRS Technique was used to detect the brain signals of related metabolites glutamic acid (Glu) and 1-aminobutyric acid (GABA), so as to elucidate the network regulation of lever-positioning operation on the analgesic brain effect of LDH and the biochemical mechanism of central nervous system. This multimodal MRI technique provides biological basis for the clinical application of lever localization in LDH.
- Conditions
- Lumbar Disc Herniation, Multimodal Brain Function, Analgesia Mechanism, Lever Positioning Manipulation
- Being tested
- Group1 (lever positioning manipulation), Group2 (placebo group)
- 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.
Group1 (lever positioning manipulation)Procedure or surgery
The specific lever positioning manipulation is as follows: the patient lies prone at the mouth-open position with muscles relaxed, waist exposed, knees and hips bent, and ankle joints crossed. The practitioner uses the right elbow olecranon to point at the lumbar vertebrae, then hold the patient's two ankle joints in both hands to cause the lumbar vertebra to make hyperextension and flexion movements through the arms and pull the patient backward and upwards hard. When pulling upwards to the trigger point, the practitioner pulls wit lever quickly with a technique and then senses a clatter or looseness at the positioning point. When the practitioner pulls with lever manipulation, the patient is asked to exhale and then inhale at the end of the manipulation.
Group2 (placebo group)Procedure or surgery
The specific sham lever positioning manipulation is as follows: the patient lies prone with his mouth open, muscles relaxed, waist exposed, knees bent at the hip and ankles crossed. The practitioner points to the lumbar spine with the right elbow olecranon, and then holds the patient's two ankles in both hands, so that the lumbar spine through the arm for overextension and flexion, and forcefully pulls the patient back and up. When pulling up to the trigger point, maintain this movement for a short period of time, depending on the patient's endurance, about 1-5 minutes. After finishing, ask the patient to rest in prone position.
| Study group | Role | What they receive |
|---|---|---|
| Group1 (lever positioning manipulation) | Experimental | Patients with lumbar disc herniation treated by lever positioning manipulation Receives: Procedure: Group1 (lever positioning manipulation) |
| Group2 (placebo group) | Active comparator | Patients with lumbar disc herniation treated by sham lever positioning manipulation Receives: Procedure: Group2 (placebo group) |
| Group3 (healthy controls) | No intervention | Healthy control group without any intervention. |
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 month
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 month
Regional Homogeneity (ReHo)
The ReHo measures the consistency of the local functional activities of the brain's various regions.
Measured: up to one month
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 month
Diffusion Tensor Imaging (DTI)
The DTI is used to look at images of white matter fiber structures in the brain.
Measured: up to one month
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 posted14 Nov 2022
- Study start1 Sep 2021
- 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 (2)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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Xingchen, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Zhi-zhen Lv, Dr., Study director, The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, 310053, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613179
- Sponsor's protocol ID
- ZSLL-KY-2022-049-01
- Status last verified
- Jun 2025
- First submitted
- 24 Oct 2022
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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, Huang YS, Xia Q, Lv ZZ, Lv LJ. Remodeling of the ventral attention network-default mode network as potential neural correlates of anxiety in lumbar disc herniation patients treated with lever positioning manipulation: a resting-state fMRI study. BMC Complement Med Ther. 2026 Mar 16;26(1):181. doi: 10.1186/s12906-026-05343-0.
PubMed 41840560Zhou XC, Chen LH, Wu S, Wang KZ, Wei ZC, Li T, Huang YS, Hua ZH, Xia Q, Lv ZZ, Lv LJ. Brain effect mechanism of lever positioning manipulation on LDH analgesia based on multimodal MRI: a study protocol. BMC Complement Med Ther. 2024 Jun 24;24(1):246. doi: 10.1186/s12906-024-04549-4.
PubMed 38915038
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 Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI
- ClinicalTrials.gov ID
- NCT05613179
- Acronym / sponsor ID
- ZSLL-KY-2022-049-01
- Conditions
- Lumbar Disc Herniation, Multimodal Brain Function, Analgesia Mechanism, Lever Positioning Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 14 Nov 2022 (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.
In order to further investigate the key brain targets and central response mechanism characteristics of analgesia, the dominant disease of LDH was taken as the object of this study, which was divided into operation group, comfort group and healthy subjects group. Firstly, DTI probabilistic tracking method was used to detect the changes of the brain white matter in each group. Then, the low-frequency amplitude (mfalff) and local consistency (ReHo) of each group were compared by fMRI scanning imaging technology, and the features of local brain functional connectivity (FC) of pain matrix related brain regions as seed points were analyzed. Finally, MRS Technique was used to detect the brain signals of related metabolites glutamic acid (Glu) and 1-aminobutyric acid (GABA), so as to elucidate the network regulation of lever-positioning operation on the analgesic brain effect of LDH and the biochemical mechanism of central nervous system. This multimodal MRI technique provides biological basis for the clinical application of lever localization in LDH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 (lever positioning manipulation) | Experimental | Procedure: Group1 (lever positioning manipulation)Patients with lumbar disc herniation treated by lever positioning manipulation |
| Group2 (placebo group) | Active comparator | Procedure: Group2 (placebo group)Patients with lumbar disc herniation treated by sham lever positioning manipulation |
| Group3 (healthy controls) | No intervention | –Healthy control group without any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients suffering from low back pain and/or radicular leg pain;
- persistent pain for at least six months that was nonresponsive to conservative treatments;
- at least one epidural or facet joint corticosteroid injection in the last past year without pain relief or with an improvement in pain of less than two months.
- Lumbar protrusion level discopathy on MRI corresponding to the level of pain.
- No interventional pain treatment was applied within the last three months and patients needed a pain score equal or greater than four on the visual analogic scale (VAS).
Key exclusion criteria (2 listed)
- 1.patients with motor deficits, systemic infection, coagulation disorders, pregnancy； 2.VAS pain score lower than four； 3.Patients with any other condition that prevents an MRI scan from being performed.
- -
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 |
|---|---|---|
| Group1 (lever positioning manipulation)The specific lever positioning manipulation is as follows: the patient lies prone at the mouth-open position with muscles relaxed, waist exposed, knees and hips bent, and ankle joints crossed. The practitioner uses the right elbow olecranon to point at the lumbar vertebrae, then hold the patient's two ankle joints in both hands to cause the lumbar vertebra to make hyperextension and flexion movements through the arms and pull the patient backward and upwards hard. When pulling upwards to the trigger point, the practitioner pulls wit lever quickly with a technique and then senses a clatter or looseness at the positioning point. When the practitioner pulls with lever manipulation, the patient is asked to exhale and then inhale at the end of the manipulation. | Procedure or surgery | Group1 (lever positioning manipulation) |
| Group2 (placebo group)The specific sham lever positioning manipulation is as follows: the patient lies prone with his mouth open, muscles relaxed, waist exposed, knees bent at the hip and ankles crossed. The practitioner points to the lumbar spine with the right elbow olecranon, and then holds the patient's two ankles in both hands, so that the lumbar spine through the arm for overextension and flexion, and forcefully pulls the patient back and up. When pulling up to the trigger point, maintain this movement for a short period of time, depending on the patient's endurance, about 1-5 minutes. After finishing, ask the patient to rest in prone position. | Procedure or surgery | Group2 (placebo group) |
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 month
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 month
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 month
The ReHo measures the consistency of the local functional activities of the brain's various regions.
Functional Connectivity (FC)
Time frame: up to one month
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.
Diffusion Tensor Imaging (DTI)
Time frame: up to one month
The DTI is used to look at images of white matter fiber structures in the brain.
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 41840560Zhou XC, Wu S, Wang KZ, Chen LH, Wei ZC, Li T, Hua ZH, Huang YS, Xia Q, Lv ZZ, Lv LJ. Remodeling of the ventral attention network-default mode network as potential neural correlates of anxiety in lumbar disc herniation patients treated with lever positioning manipulation: a resting-state fMRI study. BMC Complement Med Ther. 2026 Mar 16;26(1):181. doi: 10.1186/s12906-026-05343-0.
- Derived from this study: PubMed 38915038Zhou XC, Chen LH, Wu S, Wang KZ, Wei ZC, Li T, Huang YS, Hua ZH, Xia Q, Lv ZZ, Lv LJ. Brain effect mechanism of lever positioning manipulation on LDH analgesia based on multimodal MRI: a study protocol. BMC Complement Med Ther. 2024 Jun 24;24(1):246. doi: 10.1186/s12906-024-04549-4.
- 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, Dr. study director
The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, 310053, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group1 (lever positioning manipulation) in people with Lumbar Disc Herniation and Multimodal Brain Function, run by The Third Affiliated hospital of Zhejiang Chinese Medical University 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 6 inclusion and 2 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. 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 7 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 NCT05613179, which also lists 2 linked publications.
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.