Overview
The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).
Description
Several open studies and case series have shown improvement in pain scores using ONS specifically for cluster headache, which is the most common of the TACs. However, neuromodulation in the treatment of pain disorders is subject to strong placebo effect and bias, and the lack of controlled studies in this population makes its true efficacy unknown. Therefore, we plan to study ONS in a population of patients with chronic TACs using a double-blind, randomized, controlled, cross-over study. Using sub-threshold stimulation parameters, meaning patients will not know when therapeutic stimulation is active, subjects will rate their pain and quality of life during both therapeutic and sham stimulation periods. Following the cross-over period, all subjects will undergo therapeutic stimulation for 1-year in order to gauge long-term effects.
Eligibility
Inclusion Criteria:
- Aged between 40 and 70 years (inclusive);
- Joint pain or stiffness lasting for no less than 3 months;
- Voluntary participation with signed informed consent.
Exclusion Criteria:
- Combined with other severe joint diseases, such as rheumatoid arthritis, gout, etc.;
- Suffering from severe systemic diseases, such as heart failure, malignant tumors and others;
- Received joint surgery within the past 3 months or taking medications that may affect the progression of osteoarthritis;
- Individuals with cognitive dysfunction who are unable to cooperate with the research procedures;
- Failure to complete X-ray, MRI examination or follow-up visits as required.
