Clinical trial NCT06995066: Combined Therapy for Cervical Disc Herniation
Official title: A Study on the Treatment of Cervical Disc Herniation by Low-temperature Plasma Radiofrequency Ablation Combined With Ozone Injection and Collagenase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: VAS and JOA Scores
Adverse Reaction Rates
Clinical Efficacy at 1 Month and 6 Months
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuan
Study officials:
References: