Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


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.

Primary outcomes:
measure: Lumbar Stabilizer Muscle Function Indicators.
timeFrame: week 3 (after the completion of the 2-week treatment period)
Secondary outcomes:
measure: Clinical efficacy indicators.
timeFrame: week 3 (after the completion of the 2-week treatment period)
measure: Clinical efficacy indicators.
timeFrame: week 3 (after the completion of the 2-week treatment period)
Other outcomes:
Locations:
Study officials:
References: