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

The First Affiliated Hospital of Zhejiang Chinese Medical University

Status: Not yet enrolling

Conditions: Lumbar Disc Herniation

Treatments: Other: Spinal Manipulation; Other: Medication

Study type: Interventional

Funder types: Other

Identifiers

NCT06946979

2024-KLS-685-02

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

Healthy control group.

No Intervention group

Spinal Manipulation + Medication Group.

Experimental group

Description:

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.

Treatment:

Other: Medication

Other: Spinal Manipulation

Medication Group.

Active Comparator group

Description:

Pharmacotherapy : Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained.

Treatment:

Other: Medication