Design and rationale of the efficacy of spinal cord stimulation in patients with refractory angina pectoris (SCRAP) trial.

BACKGROUND: The use of spinal cord stimulation (SCS) in patients with refractory angina pectoris (RAP) is still under debate. Studies up to date have shown a positive effect with an improvement in quality of life. However, no double blinded randomized controlled trials have been performed. HYPOTHESIS & METHODS: The objective of this trial is to investigate if high density SCS leads to a significant reduction in the amount of myocardial ischemia in patients with RAP. Eligible patients must meet the criteria for RAP, have proven ischemia and a positive transcutaneous electrical nerve stimulator treadmill test. Patients who meet the inclusion criteria will receive an implanted spinal cord stimulator. Patients receive 6 months of high density SCS and 6 months of no stimulation using a cross-over design. The order of the treatment options is determined using randomization. The primary endpoint is the effect of SCS measured by the change in percentage of myocardial ischemia using myocardial perfusion positron emission tomography scan. Key secondary endpoints are patient related outcome measures, major cardiac adverse events and safety endpoints. The follow-up period is 1 year for the primary and key secondary endpoints. RESULTS: The SCRAP trial began enrollment on December 21, 2021 and is set to complete the primary assessments in June 2025. To date, January 2, 2023, 18 patients have been enrolled in the study and 3 patients have completed the 1-year follow-up. CONCLUSIONS: The SCRAP trial is an investigator-initiated, single-center, double-blind, placebo-controlled, and cross-over randomized controlled trial investigating the efficacy of SCS in patients with RAP. (ClinicalTrials. gov Identifier: NCT04915157).

Long-term efficacy and safety of spinal cord stimulation in patients with refractory angina pectoris.

Background: The number of patients with refractory angina pectoris (RAP), associated with poor quality of life, has been steadily increasing. Spinal cord stimulation (SCS) is a last resort treatment option leading to significant improvement in quality of life over a one year follow-up. The aim of this prospective, single-centre, observational cohort study is to determine the long-term efficacy and safety of SCS in patients with RAP. Methods: All patients with RAP who received a spinal cord stimulator from the period July 2010 up to November 2019 were included. In May 2022 all patients were screened for long-term follow-up. If the patient was alive the Seattle Angina (SAQ) and RAND-36 questionnaire were completed and if the patient had passed away cause of death was determined. The primary endpoint is the change in SAQ summary score at long-term follow-up compared to baseline. Results: From July 2010 up to November 2019 132 patients received a spinal cord stimulator due to RAP. The mean follow-up period was 65.2 ± 32.8 months. Seventy-one patients completed the SAQ at baseline and long-term follow-up. The SAQ SS showed an improvement of 24.32U (95% confidence interval [CI]: 18.71 - 29.93; p < 0.001). Conclusions: The main findings of the study show that long-term SCS in patients with RAP leads to significant improvement in quality of life, significant reduction in angina frequency, significantly less use of short-acting nitrates and a low risk of spinal cord stimulator related complications over a mean follow-up period of 65.2 ± 32.8 months.

Improvement in quality of life and angina pectoris: 1-year follow-up of patients with refractory angina pectoris and spinal cord stimulation.

AIMS: Spinal cord stimulation (SCS) is a treatment for patients with refractory angina pectoris (RAP) who remain symptomatic despite optimal medical therapy and without revascularisation options. Previous studies have shown that SCS improves the quality of life in this patient group and reduces the severity of the angina pectoris. The aim of this prospective, single-arm observational study is to show this effect in a single-centre cohort using a multidisciplinary team approach to the selection process, with a follow-up period of 1 year. METHODS AND RESULTS: Between July 2010 and March 2017, 87 patients with RAP referred to our centre received SCS. The Seattle Angina Questionnaire (SAQ) and RAND 36-Item Health Survey (RAND-36) were completed at baseline, prior to implantation, and 1 year post-implantation. After 1 year of follow-up there was a statistically significant decrease in the frequency of angina pectoris attacks from more than 4 times a day to 1-2 times a week (p < 0.001). The SAQ showed statistically significant improvement in four of the five dimensions: physical limitation (p < 0.001), angina frequency (p < 0.001), angina stability (p < 0.001) and quality of life (p < 0.001). The RAND-36 showed statistically significant improvement in all nine dimensions: physical functioning (p = 0.001), role/physical (p < 0.001), social functioning (p = 0.03), role/emotional (p < 0.05), bodily pain (p < 0.001), general health (p < 0.001), vitality (p < 0.001), mental health (p = 0.02) and health change (p < 0.001). CONCLUSION: This study showed a significant improvement in quality of life and reduction of angina pectoris severity after 1 year of follow-up in patients treated with SCS for RAP.

[Neurogenic thoracic outlet syndrome]. / Neurogeen thoracic-outletsyndroom.

Neurogenic thoracic outlet syndrome (nTOS) is a type of thoracic outlet syndrome (TOS) where compression of the brachial plexus is responsible for development of upper-extremity, head and neck symptoms. We present a 16-year-old and a 34-year-old patient with nTOS. Diagnosis in both cases was done by following the recently published reporting standards for (n)TOS. After this multidisciplinary diagnostic work-up we performed a transaxillary thoracic outlet decompression (TOD). Due to lack of literature, difficult nomenclature and complexity of diagnosis and treatment, diagnosis of nTOS is often delayed. Recent experience shows that treatment of nTOS is safe and effective, both in the short term and the long term.

Lack of impairment of kinaesthetic sensibility in cervicogenic headache patients.

To compare the cervical kinaesthetic sensibility of cervicogenic headache (CEH) patients and asymptomatic controls, the head repositioning accuracy of 10 CEH patients and 23 asymptomatic controls was measured. Should an impaired kinaesthetic sensibility be demonstrated, its assessment could be of diagnostic value in the evaluation of patients with suspected CEH. Additionally, specific exercises to improve cervical kinaesthesia could be prescribed. Kinaesthetic sensibility was assessed using a head repositioning task: subjects were asked to relocate their heads as accurately as possible to a previously memorized head position following an active movement (flexion, extension and left and right rotations). The repositioning error was registered using a validated magnetic tracking device (Flock of Birds). No significant differences were found between the asymptomatic controls and the CEH patients (independent-samples T-test, P < 0.05). We conclude that cervical kinaesthetic sensibility is not impaired in non-traumatic CEH. The use of kinaesthetic assessment and treatment in this patient group seems to be limited.

Interobserver reliability in physical examination of the cervical spine in patients with headache.

OBJECTIVE: To assess interobserver reliability of two expert headache neurologists when examining the cervical spine of patients with headache. BACKGROUND: The diagnosis of cervicogenic headache involves the physical examination of the cervical spine. METHODS: Twenty-four patients diagnosed as having migraine, tension-type headache, or cervicogenic headache were included in the study. After interview, each patient's cervical spine was examined in a structured way. Reliability was assessed by Cohen's kappa. RESULTS: Reduced range of motion in the cervical spine showed kappa scores indicating moderate agreement. Provocation of headache revealed moderate-to-substantial agreement. Assessment of zygapophyseal joint pressure pain showed slight-to-fair agreement. The kappa values of the circumscribed characteristic tender points showed agreement ranging from "not better than chance" to "substantial agreement." CONCLUSIONS: Our study showed that the interobserver reliability of expert headache neurologists was satisfactory in the majority of the physical examination tests of the cervical spine in patients with different headache syndromes. However, standardization of the clinical tests in order to improve their reliability is recommended.

The effect of paracetamol, fentanyl, and systematic assessments on children's pain after tonsillectomy and adenoidectomy.

Various clinical protocols are used to manage early postoperative tonsillectomy and/or adenoidectomy (T&A) pain in children. Although believed to be effective, these protocols are not evidenced-based. Therefore, a double-blind, randomized, placebo controlled (2 x 2) factorial design was used (1) to evaluate the effectiveness of 2 pain protocols used interchangeably to manage early postoperative T&A pain and (2) to investigate whether nurses' systematic pain assessments improve pain management. In the first protocol children receive a loading dose (30 to 50 mg/kg) of paracetamol (acetaminophen) Formularium der Nederlandse Apothekers (Formulary of the Dutch Royal Society for the Advancement of Pharmacy) intraoperatively, followed by regular doses (70 to 100 mg/kg/24 hours) of paracetamol. In the second protocol children receive the first protocol, plus intramuscular fentanyl citrate (1 microgram/kg) intraoperatively. Subjects were 83 healthy children between the ages of 3 and 12 years, admitted for T&A as an outpatient procedure. The child's pain was measured using observation scales (Children's Hospital of Eastern Ontario Pain Scale and Face Legs Activity Cry Consolability Scale), a visual analogue scale, and self-report measures (Faces Pain Scale and Oucher). Neither pain protocol sufficiently relieved early postoperative T&A pain, and systemic pain assessments did not improve the effectiveness of analgesics. Further research evaluating the effectiveness of pain management protocols is needed.

Radiofrequency cervical zygapophyseal joint neurotomy for cervicogenic headache: a prospective study of 15 patients.

The present study assessed the clinical efficacy of radiofrequency cervical zygapophyseal joint neurotomy in patients with cervicogenic headache. Fifteen consecutive patients with cervicogenic headache were treated and then assessed one week prior to treatment and, at short-term (8 weeks), intermediate (mean 8.8 months) and long-term (mean 16.8 months) follow-ups. The following were taken as outcome parameters: Visual Analogue Scale (VAS), 7-point Verbal Rating Scale (VRS), number of headache days per week and analgesic intake per week. The results of this study showed that radiofrequency neurotomy of the cervical zygapophyseal joints significantly reduced headache severity in 12 (80%) patients, both at short-term and long-term follow-up assessed by 7-point VRS. Mean VAS decrease was 31.4 mm (p < 0.001) and 53.5 mm (p < 0.0001) respectively in this period. The average mean number of headache days per week decreased from 5.8 days to 2.8 days (p = 0.001) and the average analgesic intake per week showed a reduction from a mean of 17.5 tablets to a mean of 3.4 tablets (p = 0.003). A definitive conclusion about the clinical efficacy of this treatment can only be drawn from a randomized controlled trial.