Combined Therapy for Cervical Disc Herniation

NCT06995066 | Completed

• 1 other identifier: NanchongCH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study mainly explores the efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection and collagenase in the treatment of cervical disc herniation.The primary outcomes included the collection of clinical data for all patients, such as gender, age, surgical segment, preoperative scores, and VAS and JOA scores at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups. The secondary outcomes involved evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria.

Conditions

VAS and JOA Scores; Adverse Reaction Rates; Clinical Efficacy at 1 Month and 6 Months

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) score at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups.

  The Visual Analogue Scale (VAS) score is a psychometric tool used to measure subjective experiences such as pain, anxiety, or satisfaction. The following is a detailed description of the meanings represented by specific numerical values in the VAS score, typically converted to a 0-10 numerical scale for clinical use: 0: Represents the complete absence of the measured sensation (e.g., pain) 1-2: Very mild level. Sensation is barely noticeable and does not interfere with daily activities. 3: Mild but distinct sensation. Noticeable enough to be recognized but still easily ignored or managed. Moderate level. 4-6: Moderate level. Sensation is clearly present and affects daily activities to some extent, but remains tolerable. 7-9: Severe level. Sensation dominates attention and drastically limits functionality; immediate intervention may be needed. 10: Maximal/intolerable level. Sensation is beyond endurance, rendering the individual unable to perform any normal activities.

  6 months

Secondary Outcomes (1)

• evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria

  6 months

Study Arms (2)

Study Group

EXPERIMENTAL

The study group received low-temperature plasma radiofrequency ablation and ozone injection as the control group, with the addition of collagenase injection into the epidural space.

Procedure: collagenase injection into the epidural space

Control Group

EXPERIMENTAL

The control group underwent low-temperature plasma radiofrequency ablation combined with ozone injection.

Procedure: collagenase injection into the epidural space

Interventions

collagenase injection into the epidural space PROCEDURE

The "Collagenase injection into the epidural space" is a medical procedure for treating cervical disc herniation. Firstly, the patient is positioned, and the specific location of the epidural space at the affected cervical spine segment is accurately identified with the guidance of imaging devices like fluoroscopy or CT. After local anesthesia, a special puncture needle is inserted into the epidural space following the marked path. Once the needle is in the correct position, an appropriate amount of collagenase solution is slowly injected. After the operation, the patient needs to stay in the hospital for observation to monitor vital signs and neurological conditions. The patient should rest in bed for a certain period and then gradually engage in proper activities. Additionally, personalized rehabilitation treatment plans, including physical therapy and exercise, are usually required to help with recovery.

Control Group; Study Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be diagnosed with cervical disc herniation through MRI or CT, with single-level disc protrusion (C3-C7) that occupies ≤1/3 of the central spinal canal.
• Aged between 30 and 80 years.
• Have suffered from persistent neck/shoulder pain or upper extremity radiating pain for ≥3 months.
• The pain does not respond to conventional treatments, including traction, massage, and oral medications.
• Be willing to undergo surgery therapy.
• Have no prior cervical spine surgery.

You may not qualify if:

• Cervical instability, myelopathic spondylosis, severe spinal stenosis (canal occupancy \>1/3), or ligament calcification.
• Severe osteoporosis (T-score \<-2.5).
• Extruded or sequestered disc herniation
• Coagulation disorders or active infections
• Cervical deformities, tumors, or a history of cervical spine surgery

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)