Lumbar Disc HerniationNCT06946979
Clinical Study on the Use of Massage to Reconstruct the Function of Lumbar Stabilizer Muscles and Improve the "Muscle and Bone Imbalance" of Lumbar Disc Herniation
A study testing Spinal Manipulation and Medication in people with Lumbar Disc Herniation, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
Trial summary
1. .Characterization of Stabilizing Muscle Dysfunction in LDH Patients Using advanced techniques such as high-density surface electromyography (HD-sEMG), this study will investigate the functional imbalance of lumbar stabilizing muscles in LDH patients by comparing their muscle function indicators to those of healthy… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Spinal Manipulation and Medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Meet the diagnostic criteria for LDH as outlined in the ninth edition of "Surgery," with confirmation via MRI;
- 2.Age between 20 and 50;
- 3.Simple L4/5 disc herniation; VAS score ≥30/100;
- 4.Lumbar ODI index ≥20;
- 5.No massage, acupuncture, or physical therapy within the past month;
- 6.Signed informed consent form.
Who cannot join
- 1: Exclusion criteria: history of spinal surgery or severe spinal trauma;
- 2: combined with bone tuberculosis, tumors, severe osteoporosis, etc;
- 3: combined with serious internal diseases such as cardiovascular, hematological, digestive system diseases, or psychiatric disorders;
- 4: pregnant or lactating women;
- 5: combined with autoimmune diseases, allergic diseases, acute or chronic infectious diseases accompanied by pain and joint dysfunction;
- 6: MRI showing free nucleus pulposus or accompanied by cauda equina syndrome.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- .Characterization of Stabilizing Muscle Dysfunction in LDH Patients Using advanced techniques such as high-density surface electromyography (HD-sEMG), this study will investigate the functional imbalance of lumbar stabilizing muscles in LDH patients by comparing their muscle function indicators to those of healthy controls.
- .Impact of Spinal Manipulation on Lumbar Stabilizing Muscle Function Through serial sEMG evaluations, the study will assess changes in stabilizing muscle function in LDH patients before and after spinal manipulation. This includes a focus on endurance, motor control, and reaction time, providing evidence to inform the application of spinal manipulation in LDH treatment.
- .Exploration of Mechanisms Underlying Spinal Manipulation in Improving "Musculoskeletal Imbalance" The study will examine correlations between improvements in stabilizing muscle function and clinical symptoms, such as pain relief and functional recovery. Statistical analyses of sEMG data and clinical efficacy indicators will be conducted to uncover the therapeutic characteristics of spinal manipulation in LDH intervention, offering new theoretical bases and strategies for long-term treatment and recurrence prevention.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Spinal Manipulation, Medication
- 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 ManipulationOther
Spinal Manipulation Therapy The treatment consists of two standardized steps: tendon adjustment techniques and bone-setting techniques.
The total duration for both steps is approximately 15 minutes, conducted three times per week for two consecutive weeks.
MedicationOther
Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group. | No intervention | Not described |
| Spinal Manipulation + Medication Group. | Experimental | Spinal Manipulation Therapy :
The treatment consists of two standardized steps: tendon adjustment techniques and bone-setting techniques.
The total duration for both steps is approximately 15 minutes, conducted three times per week for two consecutive weeks.
Pharmacotherapy :
Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained. Receives: Other: Spinal Manipulation; Other: Medication |
| Medication Group. | Active comparator | Pharmacotherapy :
Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained. Receives: Other: Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Stabilizer Muscle Function Indicators.
Procedure: Patients lie prone on a table with the anterior superior iliac spine at the table edge. The upper body is suspended horizontally, arms crossed over the chest or extended parallel to the floor. Patients will maintain this posture for 90-120 seconds or until unable to continue (trunk angle deviation > 5°-10°). Surface electromyography (sEMG) signals will be collected synchronously, with three repetitions averaged.
Electrode Placement: Surface EMG (ME6000, Finland) will be used to collect sEMG signals. Electrodes (0.5 cm diameter, 2 cm spacing) will be placed at the L5-S1 level for multifidus (LM) and L4-L5 for erector spinae (LE) muscles. Reference electrodes will be positioned 3 cm laterally. Sampling rate is set at 1000 Hz, with a bandpass filter of 10-500 Hz and noise level < 3.5 μV.
Evaluation Metrics: Time-domain features and frequency-domain characteristics will be combined to report surface electromyography (sEMG) signals.
Measured: week 3 (after the completion of the 2-week treatment period)
Secondary outcomes (2)
Clinical efficacy indicators.
Pain will be assessed using the Visual Analogue Scale (VAS) , internationally recognized metrics for evaluating clinical efficacy in pain . Measurements will be conducted pre-treatment and after two weeks of intervention.
Measured: week 3 (after the completion of the 2-week treatment period)
Clinical efficacy indicators.
Functional recovery will be assessed using theOswestry Disability Index (ODI), internationally recognized metrics for evaluating clinical efficacy in lumbar function. Measurements will be conducted pre-treatment and after two weeks of intervention.
Measured: week 3 (after the completion of the 2-week treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946979
- Sponsor's protocol ID
- 2024-KLS-685-02
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Use of Massage to Reconstruct the Function of Lumbar Stabilizer Muscles and Improve the "Muscle and Bone Imbalance" of Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT06946979
- Acronym / sponsor ID
- 2024-KLS-685-02
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Apr 2025 (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.
- .Characterization of Stabilizing Muscle Dysfunction in LDH Patients Using advanced techniques such as high-density surface electromyography (HD-sEMG), this study will investigate the functional imbalance of lumbar stabilizing muscles in LDH patients by comparing their muscle function indicators to those of healthy controls.
- .Impact of Spinal Manipulation on Lumbar Stabilizing Muscle Function Through serial sEMG evaluations, the study will assess changes in stabilizing muscle function in LDH patients before and after spinal manipulation. This includes a focus on endurance, motor control, and reaction time, providing evidence to inform the application of spinal manipulation in LDH treatment.
- .Exploration of Mechanisms Underlying Spinal Manipulation in Improving "Musculoskeletal Imbalance" The study will examine correlations between improvements in stabilizing muscle function and clinical symptoms, such as pain relief and functional recovery. Statistical analyses of sEMG data and clinical efficacy indicators will be conducted to uncover the therapeutic characteristics of spinal manipulation in LDH intervention, offering new theoretical bases and strategies for long-term treatment and recurrence prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group. | No intervention | – |
| Spinal Manipulation + Medication Group. | Experimental | Other: Spinal Manipulation, Other: MedicationSpinal Manipulation Therapy : The treatment consists of two standardized steps: tendon adjustment techniques and bone-setting techniques. The total duration for both steps is approximately 15 minutes, conducted three times per week for two consecutive weeks. Pharmacotherapy : Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained. |
| Medication Group. | Active comparator | Other: MedicationPharmacotherapy : Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1.Meet the diagnostic criteria for LDH as outlined in the ninth edition of "Surgery," with confirmation via MRI;
- 2.Age between 20 and 50;
- 3.Simple L4/5 disc herniation; VAS score ≥30/100;
- 4.Lumbar ODI index ≥20;
- 5.No massage, acupuncture, or physical therapy within the past month;
Key exclusion criteria (6 listed)
- 1: Exclusion criteria: history of spinal surgery or severe spinal trauma;
- 2: combined with bone tuberculosis, tumors, severe osteoporosis, etc;
- 3: combined with serious internal diseases such as cardiovascular, hematological, digestive system diseases, or psychiatric disorders;
- 4: pregnant or lactating women;
- 5: combined with autoimmune diseases, allergic diseases, acute or chronic infectious diseases accompanied by pain and joint dysfunction;
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 ManipulationSpinal Manipulation Therapy The treatment consists of two standardized steps: tendon adjustment techniques and bone-setting techniques. The total duration for both steps is approximately 15 minutes, conducted three times per week for two consecutive weeks. | Other | Spinal Manipulation + Medication Group. |
| MedicationPatients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained. | Other | Medication Group., Spinal Manipulation + Medication Group. |
Primary outcome
Lumbar Stabilizer Muscle Function Indicators.
Time frame: week 3 (after the completion of the 2-week treatment period)
Procedure: Patients lie prone on a table with the anterior superior iliac spine at the table edge. The upper body is suspended horizontally, arms crossed over the chest or extended parallel to the floor. Patients will maintain this posture for 90-120 seconds or until unable to continue (trunk angle deviation > 5°-10°). Surface electromyography (sEMG) signals will be collected synchronously, with three repetitions averaged. Electrode Placement: Surface EMG (ME6000, Finland) will be used to collect sEMG signals. Electrodes (0.5 cm diameter, 2 cm spacing) will be placed at the L5-S1 level for multifidus (LM) and L4-L5 for erector spinae (LE) muscles. Reference electrodes will be positioned 3 cm laterally. Sampling rate is set at 1000 Hz, with a bandpass filter of 10-500 Hz and noise level < 3.5 μV. Evaluation Metrics: Time-domain features and frequency-domain characteristics will be combined to report surface electromyography (sEMG) signals.
2 secondary outcomes
Clinical efficacy indicators.
Time frame: week 3 (after the completion of the 2-week treatment period)
Clinical efficacy indicators.
Time frame: week 3 (after the completion of the 2-week treatment period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation and Medication in people with Lumbar Disc Herniation, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
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 6 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: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ya Wen (15295519590, 20193060@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Stabilizer Muscle Function Indicators. (time frame: week 3 (after the completion of the 2-week treatment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.