CompletedNot Applicable

Combined Therapy for Cervical Disc Herniation

China90 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range30 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT06995066

SponsorNanchong Central Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-06-01