Muscle Pressure Correlates With Pain Levels in Fibromyalgia Patients.

BACKGROUND/OBJECTIVE: We evaluated patients with fibromyalgia syndrome (FMS) to determine whether there is a correlation between pain scores based on a 0- to 10-point visual analog scale (VAS) and muscle pressure. METHODS: One hundred forty-two patients who satisfied the American College of Rheumatology classification criteria for FMS and 38 non-FMS controls comprised the study groups. Muscle pressure was measured in mm Hg using a pressure gauge attached to a no. 22 needle inserted into the midportion of the trapezius muscle. The muscle pressure was then correlated with the VAS pain score of 0 to 10, some with an increment of 0.5. A second muscle pressure was obtained from 19 patients at a subsequent visit, which was compared with their pain scores. RESULTS: The mean (SD) pain score for 142 patients with FMS was 6.6 (SD, 1.84) on a 0- to 10-point VAS. The mean pain score in the non-FMS subjects was 0.7 (SD, 1.26). The mean muscle pressure in the FMS group was 32.9 (SD, 6.57) mm Hg. The mean muscle pressure in the non-FMS subjects was 10.6 (SD, 3.85) mm Hg. The calculated Pearson correlation coefficient for muscle pressure versus pain score was 0.8312 ( p < 0.0001). This indicates a highly significant association between subjects' muscle pressure and pain scores. For the repeat muscle pressures, the change in muscle pressure was correlated with the change in pain score, and the resulting Pearson correlation coefficient was 0.9255 ( p < 0.0001). These results again indicate a highly significant association between subjects' muscle pressure and pain scores. CONCLUSION: The results show that increased muscle pressure may be a significant cause of pain in FMS, and the etiology of the pain may have a large peripheral component in addition to a centralized origin of the pain.

Pegloticase efficacy and safety in kidney transplant recipients; results of the phase IV, open-label PROTECT clinical trial.

INTRODUCTION: Kidney transplant (KT) recipients have a high prevalence and severity of gout. Pegloticase (pegylated recombinant uricase) rapidly metabolizes serum uric acid (sUA), and its efficacy is not impacted by kidney function. METHODS: This open-label, Phase 4 trial (PROTECT NCT04087720) examined safety and efficacy of pegloticase in 20 participants with KT > 1 year prior to enrollment and with uncontrolled gout (sUA ≥7 mg/dL, intolerance/inefficacy to urate lowering therapy, and ≥1 of the following: tophi, chronic gouty arthritis, ≥2 flares in past year) and functioning KT (estimated glomerular filtration rate [eGFR] ≥15 mL/min/1.73 m2 ) on stable immunosuppression therapy. RESULTS: The primary endpoint was sUA response during month 6 (sUA < 6 mg/dL for ≥80% of time). The study enrolled 20 participants (mean ± SD); age: 53.9 ± 10.9 years, time since KT: 14.7 ± 6.9 years, sUA: 9.4 ± 1.5 mg/dL, gout duration: 8.4 ± 11.6 years; all on ≥2 stable doses of immunosuppression agents. Pegloticase (8 mg intravenous every 2 weeks) in KT recipients with uncontrolled gout showed a high response rate of 89% (16/18 responders). Two participants discontinued treatment solely due to COVID-19 concerns prior to month 6 were not included in the primary analysis. Pegloticase exposures were higher than those historically observed with pegloticase monotherapy, and no anaphylaxis or infusion reaction events occurred during the study. CONCLUSIONS: This improved response rate to pegloticase in the KT population reflects observations from other trials and reports on immunomodulation with pegloticase. As the KT population has a high prevalence of gout and limitations with oral urate lowering medication options, these findings suggest a potential option for uncontrolled gout therapy in KT participants.

The Vast Majority of Patients With Fibromyalgia Have a Straight Neck Observed on a Lateral View Radiograph of the Cervical Spine: An Aid in the Diagnosis of Fibromyalgia and a Possible Clue to the Etiology.

OBJECTIVE: A straight cervical spine is an underappreciated and often overlooked finding in fibromyalgia. The aim of this medical records review study was to evaluate the cervical curvature on radiographs of patients with fibromyalgia. METHODS: A consecutive series of 270 cervical spine radiographs of patients with neck pain from 2015 to 2018 were retrospectively analyzed for cervical curvature using the Cobb angle measurement. One hundred fifty-five patients met full American College of Rheumatology criteria for fibromyalgia, whereas 115 subjects with other rheumatic diseases who were similar in age and education served as control subjects. RESULTS: Mean cervical curvature in fibromyalgia was 6.4 ± 5.2 degrees and 13.8 ± 7.4 degrees in control subjects. The more than 7-degree difference was significant ( p < 0.001). Curvature in the magnitude of 21 degrees is at the low end of normal. At ≤10 degrees, where the cervical spine is essentially straight, there were 129 fibromyalgia patients (83.2%) and 37 control subjects (32.2%). The 51% difference was significant ( p < 0.001). CONCLUSION: Most patients with fibromyalgia share an abnormality in common that is verifiable by a simple radiograph. In 83.2% of the patients, the cervical spine was essentially straight (Cobb angle ≤10 degrees). In fibromyalgia patients, the loss of cervical curvature was approximately 6.5 times greater than in control subjects (50.3% vs. 7.8%). A straight neck without other radiographic abnormalities may be a major anatomical abnormality in fibromyalgia that has gone unnoticed. It may assist in the diagnosis, as well as suggest increased muscle tension/pressure as a possible etiology.

Retinal structure and function in vigabatrin-treated adult patients with refractory complex partial seizures.

OBJECTIVE: Evaluate visual-field and retinal-structure changes following adjunctive vigabatrin treatment in vigabatrin-naive adults with refractory complex partial seizures (rCPS). METHODS: Prospective, longitudinal, single-arm, open-label study (NCT01278173). Eligible patients (≥2 seizures/month who failed ≥3 therapies) who could reliably perform perimetry (Humphrey automated static) and retinal-structure assessment (spectral-domain optical coherence tomography) prior to vigabatrin exposure. Following vigabatrin initiation, testing occurred within 1 month (reference) and 3, 6, 9, and 12 months. End points included mean change from reference in mean deviation (dB) and average retinal nerve fiber layer (RNFL) thickness, visual-acuity changes from baseline, and number of patients who met predefined vision-parameter changes at two (confirmed) or three (persistent) consecutive visits. RESULTS: Sixty-five of 91 screened patients received ≥1 vigabatrin dose (all-patients-treated set [APTS]); 55 had valid reference and ≥1 post-reference assessments (full-analysis set [FAS]). Thirty-six APTS patients with valid pre-/post-reference values completed all planned visits (per-protocol set [PPS]). Thirty-eight (59%) APTS patients completed the study; 27 (42%) withdrew (none for visual-field changes); 32% and 15% had abnormally thin RNFL and abnormal visual acuity at baseline, respectively; 20% had abnormal central 30 degree visual fields in the reference period. No significant mean near visual-field changes were observed (PPS); mean change in average RNFL thickness increased significantly (1-year data: Left-eye: 6.37 µm, confidence interval (CI) 4.66-8.09; right-eye: 7.24 µm CI 5.47-9.01; PPS). No confirmed three-line decreases in visual acuity (FAS) were observed; five patients had predefined confirmed/persistent visual-field changes (FAS). All vision-related adverse events were nonserious; the most common was vision blurred (9%). SIGNIFICANCE: Prior to vigabatrin initiation, rCPS patients may already exhibit vision deficits. Up to 1 year of adjunctive vigabatrin treatment did not significantly change population near visual fields. Five patients met predefined visual-field-change criteria. RNFL thickening of unknown clinical significance was observed. Limitations include single-arm, open-label design; patients' inability to perform ophthalmic/visual-field examinations; and limited vigabatrin-exposure duration.