A Comparison of Pain Control AND Quality of Life Improvement Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation: A Double-Blind Single Center Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 主要终点
- Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
研究概览
简要总结
This is a randomized, double blind, single-center, clinical trial. The study will be conducted over a period of 6 months. The study will be conducted at the Allevio Pain Clinic, Toronto, Canada.
详细描述
During the first visit the investigator will assess potential subject's eligibility. Screening and recruitment, and randomization, and administer questionnaires will be performed by research coordinator. Study informed consent form (ICF) can be signed on the RF procedure day. If additional visits will be required to finalize the procedures related to the first visit they will be scheduled accordingly. After randomization the qualified participants will be scheduled for their bilateral Occipital RF or bilateral Occipital Block.
Participants will be asked to complete the follow-up questionnaires at baseline, 3 and 6 months. On their last study visit, participants will have an exit interview, in addition to completing study measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Once eligible, the Redcap will assign the patient to one of the study group. Patients and physician provider will be blinded in the proposed study. Study questionnaires will be completed every three months by patients through RedCap System. Provider physician (here Dr.Rahul Shivaji Pathak) is the person who will perform the procedure.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90
- •Confirmed diagnosis of occipital headaches, patients with concurrent other types of headaches will not be excluded (except undiagnosed headaches)
- •Duration of occipital headaches > 3 months
排除标准
- •Non-English speakers;
- •Refusal to sign informed consent;
- •Allergy to medications which will be used in the study;
- •Concurrent undiagnosed headaches
- •Current brain tumors
- •Current known tumors with known metastasis in other organs
- •Occipital blocks within the last 3 months
- •Currently receiving treatment with Botox for migraine.
- •Patient has RF of occipital nerve/s within the last year
结局指标
主要结局
Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
时间窗: Change from baseline BPI-SF at 6 months
measured by Short Form Brief Pain Inventory (BPI-SF), between minimum of zero and maximum of ten
次要结局
- Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)(Baseline, every 3 months up to 6 months)
- Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)(Baseline, every 3 months up to 6 months)
- Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC)(Baseline, every 3 months up to 6 months)
- Quality of life assessment(Baseline, every 3 months up to 6 months)
- At Least of 30% decrease in the pain score(Baseline, every 3 months up to 6 months)