Cervicogenic headache (CEH), a chronic unilateral headache originating from the cervical spine, affects a significant portion of the population, with prevalence ranging from 2.2% to 20% in individuals experiencing chronic headaches. Current treatments offer only temporary relief and come with adverse effects, highlighting the need for safer and more effective therapeutic options. A new randomized controlled trial aims to investigate the impact of combining ultrasound-localized meridian massage with injections into the greater and third occipital nerves for CEH patients.
Innovative Approach to CEH Treatment
The study introduces an innovative ultrasound localization technique for guiding meridian sinew tuina therapy, followed by targeted injections into the greater and third occipital nerves. This method offers a precision advantage over traditional body palpation and C-arm guided localization, allowing for the accurate release of the entrapped occipital nerves and adjacent soft tissues. The trial will assess the effectiveness of this approach in improving pain score indices, headache visual analog scores, pain intensity, and cervical spine mobility in CEH patients.
Trial Design and Methodology
The study is designed as a single-center, randomized, parallel-controlled trial. Participants will be randomly allocated to either the control group, receiving ultrasound-guided injections into the greater and third occipital nerves (GON and TON), or the intervention group, undergoing ultrasound-localized meridian sinew tuina in conjunction with GON and TON injections. The effectiveness of these treatments will be assessed at baseline, 3 days post-treatment commencement, 15 days post-treatment conclusion, and 30 and 60 days following the end of treatment.
In the control group, injections consist of a compound betamethasone solution diluted with 0.9% sodium chloride solution. The procedural methodology for ultrasound-guided GON and TON injections adheres to established guidelines. The intervention entails daily meridian sinew tuina therapy for three consecutive days, with each session spanning 30 minutes. On the third day, participants receive a single session of ultrasound-guided injections into the greater and third occipital nerves (GON and TON), marking the completion of the treatment course.
Observational Indicators and Data Analysis
Primary outcomes will be measured using the Short-Form McGill Pain Questionnaire (SF-MPQ), a globally recognized instrument for describing and quantifying pain experiences. Secondary observational indicators include Cervical Range of Motion (ROM) and Medical infrared thermography. The study employs the X640D digital infrared thermography system by Ge Wu You Xin Company. Image analysis is conducted using IRToolPRo software, which provides a comprehensive temperature detection range from 0°C to 300°C with a precision of ±0.3°C.
The principle of Intention-To-Treat (ITT) analysis and Per-Protocol (PP) analysis will be followed in the process of statistical analysis. For the primary outcome, SF-MPQ scores will be assessed by using the linear mixed-effects model with the interaction effects of time and group. All statistical analyses will be conducted with SPSS software, version 25.0 (SPSS Inc).
Significance and Limitations
This study heralds several innovative approaches and advantages, primarily in clinical treatment methodology. Utilizing ultrasound technology, the anatomical locations of the greater and third occipital nerves (GON and TON) are precisely identified, enabling targeted meridian sinew tuina. The integration of meridian sinew tuina with GON and TON injections represents a novel approach that may accelerate recovery in cervicogenic headache (CEH) patients, fostering a synergistic effect between sympathetic nervous system and traditional Chinese therapeutic massage.
Being conducted at a single center, the study’s ability to generalize findings across different populations is restricted. Additionally, the intrinsic characteristics of meridian massage preclude the possibility of blinding practitioners and participants, challenging the implementation of a double-blind randomized controlled trial (RCT). Despite these constraints, the study adheres strictly to separation principles among operators, allocators, and statisticians to mitigate potential biases.
