Combined Therapy for Cervical Disc Herniation

NCT ID: NCT06995066

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-07-01

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.

Detailed Description

1. Research Objective 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. By establishing this objective, the study sets the overall direction, aiming to comprehensively evaluate how this combined treatment impacts the therapeutic outcomes and safety profile of patients suffering from cervical disc herniation. This objective serves as the cornerstone, guiding the selection of outcome measures, data collection methods, and the overall research design.

2. Primary Outcome Measures 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. Firstly, the collection of comprehensive clinical data from all participants, including demographic information like gender, age, and the specific surgical segment, provides a detailed characterization of the patient cohort. This baseline data is crucial for understanding the patient population's characteristics, enabling researchers to account for potential confounding factors during data analysis and ensuring the validity of the study results.

Secondly, the collection of preoperative scores, along with Visual Analog Scale (VAS) and Japanese Orthopaedic Association (JOA) scores at multiple postoperative time points (1 week, 1 month, 3 months, and 6 months), allows for a dynamic assessment of treatment efficacy. The VAS scores track the evolution of pain levels over time, offering a direct measure of how effectively the treatment alleviates patients' discomfort. Meanwhile, the JOA scores evaluate the recovery of cervical spine function, providing insights into the overall improvement of patients' quality of life and functional ability. By monitoring these scores at different intervals, researchers can observe the treatment's short-term and long-term effects, identify trends in patient recovery, and determine the optimal time frame for achieving the best outcomes.

Lastly, the comparison of adverse reaction rates between the two groups is a pivotal component for evaluating treatment safety. By systematically documenting and contrasting the occurrence of adverse events, such as allergic reactions, infections, or neurological complications, researchers can determine whether the combined treatment poses a higher risk to patients. This comparison helps in balancing the potential benefits of the treatment against its associated risks, guiding clinical decision-making and ensuring patient well-being.

3. Secondary Outcome Measures The secondary outcomes involved evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria. Utilizing the modified Macnab criteria to evaluate clinical efficacy at 1 month and 6 months post-surgery provides a standardized, comprehensive framework for gauging treatment success. This criteria assesses multiple dimensions of patient recovery, including symptom relief, functional improvement, and patient satisfaction. By incorporating a broader range of factors beyond just pain and function scores, it offers a more holistic understanding of the treatment's impact on patients' overall condition. This secondary evaluation complements the primary outcome measures, providing additional evidence to support the study's findings and enhancing the robustness of the conclusions regarding the combined treatment's efficacy.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Group

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.

Group Type: EXPERIMENTAL

collagenase injection into the epidural space

Intervention Type: 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

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

Group Type: EXPERIMENTAL

collagenase injection into the epidural space

Intervention Type: 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.

Interventions

collagenase injection into the epidural space

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanchong Central Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanchong Central Hospital

Nanchong, Sichuan, China

Countries

China

Other Identifiers

NanchongCH

Identifier Type: -

Identifier Source: org_study_id