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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Other: Spinal Manipulation; Other: Medication

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ya Wen; Phone Number: 15295519590; Email: 20193060@zcmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy control group.
Experimental: Spinal Manipulation + Medication Group.; 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.	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.
Active Comparator: Medication Group.; Pharmacotherapy : Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained.	Other: Medication; Patients in both groups will receive celecoxib (one tablet, twice daily) for two weeks, with detailed records maintained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 3 (after the completion of the 2-week treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	week 3 (after the completion of the 2-week treatment period)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Intervertebral Disc Displacement; Hernia
• Other Study ID Numbers: 2024-KLS-685-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No