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Not yet recruiting NCT06946979

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

No phase Interventional Lumbar Disc Herniation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal Manipulation, Medication.
Who it may be relevant to
Registry conditions: Lumbar Disc Herniation. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 controls. 2. .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. 3. .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.

Interventions

  • Other Spinal Manipulation
    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.
  • Other Medication
    Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained.

Primary outcome measures

  • Lumbar Stabilizer Muscle Function Indicators. [Time frame: week 3 (after the completion of the 2-week treatment period)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06946979 · 2024-KLS-685-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗