scholarly journals Different Pulsed Radiofrequency Modes on Gasserian Ganglion Improved Acute/subacute Zoster-related Trigeminal neuralgia: A Randomized, Double-Blinded, Controlled Trial

2020 ◽  
Author(s):  
Cheng-fu Wan ◽  
Tao Song
Keyword(s):  
Trigeminal Neuralgia ◽  
High Voltage ◽  
Short Form ◽  
Controlled Trial ◽  
Gasserian Ganglion ◽  
Pulsed Radiofrequency ◽  
Clinical Trial Registration ◽  
Time Points ◽  
Long Duration ◽  
Sf 36

Abstract Background: Trigeminal postherpetic neuralgia (PHN), developed from herpes zoster virus infected on gasserian ganglion, is a severe neuropathic pain and often refractory to existing treatment. Pulsed radiofrequency (PRF) is known to be effective for treating acute/subacute zoster-related pain, but the effectiveness of different PRF mode has not been tested.Objective: This study aimed to investigate the efficacy and safety of different PRF modes on gasserian ganglion in patients with acute/subacute zoster-related trigeminal neuralgia.Methods: 120 patients were equally randomized into 2 groups (n = 60): high-voltage, long-duration PRF(HL-PRF) group and standard PRF(S-PRF) group. One cycle high-voltage, long-duration PRF was applied in HL-PRF group and three cycles standard PRF were performed in S-PRF group. Visual analog scales (VAS), 36-item short form health survey scores (SF-36) and average doses of pregabalin were recorded at different time points. Results: There were significant declined in VAS and SF-36 scores in both two groups at different time point after PRF treatment (P < 0.001). The scores of VAS and SF-36 in HL-PRF group were significantly lower than those in S-PRF group at different time points after treatment (P < 0.05). The dosages of pregabalin were also lower in HL-PRF group at days 3, 14 and 28 after treatment (P < 0.05). There was no serious adverse effect in either group. Conclusion: High-voltage, long-duration PRF on gasserian ganglion is more effective than standard PRF for acute/subacute zoster-related trigeminal neuralgia patients. Clinical Trial Registration: ChiCTR2000038775

scholarly journals High-Voltage, Long-Duration Pulsed Radiofrequency on Gasserian Ganglion Improves Acute/Subacute Zoster-Related Trigeminal Neuralgia: A Randomized, Double-Blinded, Controlled Trial

2019 ◽  
Vol 4 (22;4) ◽  
pp. 361-368
Author(s):  
Tao Song
Keyword(s):  
Trigeminal Neuralgia ◽  
High Voltage ◽  
Postherpetic Neuralgia ◽  
Sham Group ◽  
Short Form ◽  
Gasserian Ganglion ◽  
Pulsed Radiofrequency ◽  
Long Duration ◽  
Sf 36 ◽  
Double Blinded

Background: Trigeminal postherpetic neuralgia is a severe neuropathic pain and often refractory to existing treatment, it develops secondary to herpes zoster-infected Gasserian ganglion. Therefore, it is important to prevent the transition of acute/subacute zoster-related pain to trigeminal postherpetic neuralgia. Despite numerous studies, the optimal intervention that reduces trigeminal postherpetic neuralgia incidence is still unknown. Objectives: This study aimed to evaluate the efficacy and safety of high-voltage, long-duration pulsed radiofrequency (PRF) on the Gasserian ganglion in patients with acute/subacute zosterrelated trigeminal neuralgia. Study Design: Prospective, randomized, double-blinded study. Setting: Department of Pain Medicine, the First Affiliated Hospital of China Medical University. Methods: Ninety-six patients with acute/subacute zoster-related trigeminal neuralgia were equally randomly assigned into 2 groups. The electrode needle punctured the Gasserian ganglion guided by computed tomography in every patient. High-voltage, long-duration PRF at 42°C for 900 seconds was applied in the PRF group (n = 48). It was also applied in the sham group (n = 48) without radiofrequency energy output. The therapeutic effects were evaluated using a visual analog scale (VAS) and the 36-Item Short Form Health Survey (SF-36) at different time points. The average dosage of pregabalin (mg/d) administrated within the first month after treatment was also recorded. Results: The postprocedure VAS scores in the PRF group were significantly lower than those in the sham group at different time points after treatment (P < 0.01). The SF-36 scores, which included physical functioning, physical role, bodily pain, general health perceptions, vitality, social function, emotional role, and the mental health index, were significantly improved at the sixth month after treatment in the PRF group compared with the sham group (P < 0.01). The average dosage of pregabalin administered (mg/d) within the first month after treatment was also significantly reduced in the PRF group compared with the sham group (P < 0.01). There were no bleeding, infection, or other severe side effects in both groups. Limitations: Single center study, relatively small number of patients. Conclusions: High-voltage, long-duration PRF on the Gasserian ganglion is an effective and safe therapeutic alternative for patients with acute/subacute zoster-related trigeminal neuralgia. Key words: Pulsed radiofrequency, zoster-related trigeminal neuralgia, visual analog scale, 36- Item Short Form Health Survey

scholarly journals Bipolar High-Voltage, Long-Duration Pulsed Radiofrequency Improves Pain Relief in Postherpetic Neuralgia

2016 ◽  
Vol 5;19 (5;19) ◽  
pp. E721-E728
Author(s):  
Tao Song
Keyword(s):  
Clinical Trial ◽  
High Voltage ◽  
Postherpetic Neuralgia ◽  
Short Form ◽  
Control Group ◽  
Therapeutic Effects ◽  
Pulsed Radiofrequency ◽  
Long Duration ◽  
Number Of Patients ◽  
Sf 36

Background: Postherpetic neuralgia (PHN) is often refractory to existing treatments. Treatment of the dorsal root ganglion (DRG) using monopolar pulsed radiofrequency (PRF), which is a nonor minimally neurodestructive technique, is not efficacious in all patients. Objectives: This study aimed to determine the safety and clinical efficacy of bipolar highvoltage, long-duration PRF on the DRG in PHN patients. Study Design: Self before-after controlled clinical trial. Setting: Department of Pain Medicine, the First Affiliated Hospital of China Medical University. Methods: Ninety patients diagnosed with PHN for > 3months were included. Bipolar highvoltage, long-duration PRF at 42°C for 900 seconds was applied after the induction of paresthesias covered the regions of hyperalgesic skin. The therapeutic effects were evaluated using a visual analog scale (VAS) and the 36-item Short Form health survey (SF-36) before treatment and one, 4, 8, and 12 weeks after PRF. Results: The VAS scores at one, 4, 8, and 12 weeks after PRF treatment were significantly lower than before treatment (P < 0.001). The SF-36 scores, which included physical functioning, physical role, bodily pain, general health perceptions, vitality, social function, emotional role, and the mental health index, were significantly improved up to 12 weeks after PRF treatment (P < 0.001). No serious adverse effects were identified following treatment. The main adverse reactions included pain, tachycardia, and high blood pressure (especially when the field strength was enhanced). Limitations: Single center study, relatively small number of patients, lack of a control group. Conclusion: Bipolar high-voltage, long-duration PRF on the DRG is an effective and safe therapeutic alternative for PHN patients. This treatment could improve the quality of life of PHN patients. Clinical Trial Registration: NO ChiCTR-OCS-14005461 Key words: Pulsed radiofrequency, postherpetic neuralgia, VAS, SF-36

scholarly journals Efficacy of Pulsed Radiofrequency or Short-Term Spinal Cord Stimulation for Acute/Subacute Zoster-Related Pain: A Randomized, Double- Blinded, Controlled Trial

2021 ◽  
pp. 215-222
Author(s):  
Tao Song
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Rating Scale ◽  
Short Form ◽  
Numeric Rating Scale ◽  
Pulsed Radiofrequency ◽  
Short Term ◽  
Time Points ◽  
Sf 36 ◽  
Double Blinded

Background: Postherpetic neuralgia (PHN) is the final stage of varicella zoster infection and a severe refractory neuropathic pain. Hence preventing transition of herpes zoster-related pain to PHN is a very important therapeutic principle for patients at an early stage, especially for older patients.Both pulsed radiofrequency (PRF) and short-term spinal cord stimulation (stSCS) have been proven to be effective to relieve acute/subacute zoster-related pain. However, which treatment could achieve better analgesic effects remains unclear. Objectives: This study aimed to investigate the therapeutic efficacy and safety of PRF and stSCS in patients with acute/subacute zoster-related pain. Study Design: Prospective, randomized, double-blinded study. Setting: Department of Pain Medicine, the First Affiliated Hospital of China Medical University. Methods: Ninety-six patients with acute/subacute zoster-related pain were equally randomized into 2 groups: PRF group and stSCS group. Patients in the different groups were treated with high-voltage, long-duration PRF or stSCS. The therapeutic effects were evaluated using a Numeric Rating Scale (NRS-11) and the 36-Item Short Form Health Survey (SF-36) at different time points. The average dose of pregabalin (mg/d) administrated at different time points was also recorded. Results: The posttreatment NRS-11 scores in the 2 groups were significantly lower compared with baseline (P < 0.001). The NRS-11 scores in the stSCS group were significantly lower than those in the PRF group at 30 and 180 days after treatments (P < 0.05). The SF-36 scores of general health, social function, role-emotional, mental health, bodily pain, physical function, physical role, and vitality could be significantly improved at each time point after treatments in the 2 groups. Some SF-36 scores could be significantly improved at some time points in the stSCS group compared with the PRF group. The rescue drug (pregabalin) dosages were lower in the stSCS group than those in the PRF group at days 90 and 180 after treatments. There was no bleeding at the puncture site, infection, postoperative paresthesia, nerve injury, or any other serious adverse effects in either group. Limitations: Single-center study, relatively small number of patients. Conclusions: PRF and stSCS are both effective and safe therapeutic alternatives for patients with acute/subacute zoster-related pain, however, stSCS could achieve more pain relief and improvement of life quality compared with PRF. Key words: Pulsed radiofrequency, short-term spinal cord stimulation, zoster-related pain, Numeric Rating Scale, 36-Item Short Form Health Survey

scholarly journals Aerobic Exercise Therapy in Ambulatory Patients With ALS: A Randomized Controlled Trial

2019 ◽  
Vol 33 (2) ◽  
pp. 153-164 ◽  
Author(s):  
Annerieke C. van Groenestijn ◽  
Carin D. Schröder ◽  
Ruben P. A. van Eijk ◽  
Jan H. Veldink ◽  
Esther T. Kruitwagen-van Reenen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Aerobic Exercise ◽  
Exercise Therapy ◽  
Short Form ◽  
Controlled Trial ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Ambulatory Patients ◽  
Disease Specific

Background: Weakness caused by motor neuron degeneration in amyotrophic lateral sclerosis (ALS) may result in avoidance of physical activity, resulting in deconditioning and reduced health-related quality of life (HRQoL). Objective: To study the effectiveness of aerobic exercise therapy (AET) on disease-specific and generic HRQoL in ambulatory patients with ALS. Methods: We conducted a multicenter, assessor-blinded, randomized controlled trial. Using a biphasic randomization model, ambulatory ALS patients were assigned (1:1) to AET+usual care (UC), or UC. AET consisted of a 16-week aerobic cycling exercise program. Primary outcome measures were the 40-item ALS assessment questionnaire (ALSAQ-40), and the mental component summary (MCS) and physical component summary (PCS) scores of the short-form survey (SF-36), using linear mixed effects models. Per-protocol (PP) analysis was performed for those patients who attended ≥75% of the training sessions; controls were matched (1:1) by propensity score matching. Results: Of 325 screened patients, 57 were randomized: 27 to AET+UC and 30 to UC. No significant mean slope differences between groups were observed for ALSAQ-40 (-1.07; 95% confidence interval [CI] -2.6 to 0.5, P=0.172) nor for SF-36 MCS (0.24; -0.7 to 1.1, P=0.576) or PCS (-0.51; -1.4 to 0.38, P=0.263). There were no adverse events related to the AET. PP-analyses showed significantly less deterioration in ALSAQ-40 (-1.88, -3.8 to 0.0, P=0.046) in AET+UC compared to UC. Conclusions: AET+UC was not superior to UC alone in preserving HRQoL in ambulatory ALS patient. However, the study was unfortunately underpowered, because only 10 patients completed the protocol. AET+UC may preserve disease-specific HRQoL in slow progressors. Clinical trial registration number: Netherlands National Trial Register (NTR): 1616.

Comparing durability of water- and land-based exercise benefits among older adults in South Korea: A randomized controlled trial with 1-year follow-up

2021 ◽  
pp. 1-11
Author(s):  
Se Jun Oh ◽  
Sang Heon Lee
Keyword(s):  
Exercise Intervention ◽  
External Rotation ◽  
Short Form ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Aquatic Exercise ◽  
Step Test ◽  
Sf 36 ◽  
Partial Weight

BACKGROUND: Aquatic exercise can improve strength, flexibility, and aerobic function while safely providing partial weight-bearing support through viscosity and buoyancy. OBJECTIVE: The aim of the present study was to compare the effects of water-based exercise with land-based exercise before and after a 10-week exercise intervention and again at one-year follow-up. METHODS: Eighty participants aged 65 years and older were randomly assigned to either a water- or a land-based 10-week exercise program. Assessment included the Senior Fitness Test (SFT), the Modified Falls-Efficacy Scale, and the 36-Item Short-Form Health Survey (SF-36). Hip and knee strength was also measured. All assessments were completed at three time points: pre- (T1), post- (T2), and at 1-year follow-up (T3). RESULTS: Significant differences were observed between the two groups on three parameters: the SFT timed up-and-go test; lower hip muscle strength in extension, adduction, and external rotation; and quality of life (QoL) measured by the SF-36 (p< 0.05). No significant differences were observed in the SFT chair stand test, dominant arm curl test, two-minute step test, chair sit-and-reach test, back scratch test, and Modified Falls-Efficacy Scale. CONCLUSION: Aquatic exercise provided greater improvement of physical health and QoL among older people than land-based exercise.

scholarly journals Effects of Pulsed Versus Conventional Versus Combined Radiofrequency for the Treatment of Trigeminal Neuralgia: A Prospective Study

2017 ◽  
Vol 6 (20;6) ◽  
pp. E873-E881
Author(s):  
Ghaydaa A. Ghaydaa A.
Keyword(s):  
Pain Relief ◽  
Trigeminal Neuralgia ◽  
Prospective Study ◽  
University Hospital ◽  
Gasserian Ganglion ◽  
Pulsed Radiofrequency ◽  
Group Setting ◽  
Idiopathic Trigeminal Neuralgia ◽  
Number Of Patients ◽  
A Prospective Study

Background: During radiofrequency bursts of energy are applied to nervous tissue. The clinical advantages of this treatment remain unclear. Objectives: We compared the effectiveness and pain relief for idiopathic trigeminal neuralgia (TN) after continuous radiofrequency (CRF), pulsed radiofrequency (PRF), and combined continuous and pulsed radiofrequency (CCPRF) treatment of the Gasserian ganglion (GG). Study Design: We conducted a randomized prospective study. Forty-three patients were included. Eleven patients were treated with PRF at 42°C for 10 minutes (PRF group), 12 patients received CRF for 270 seconds at 75 °C (CRF group), and 20 patients received PRF for 10 minutes at 42°C followed by CRF for at 60°C for 270 seconds (CCPRF group). Setting: Assuit University Hospital, Pain and Neurology outpatient clinics. Methods: Patients were assessed for pain, satisfaction, and consumption of analgesics at baseline and 7 days, one month, 6 months, 12 months, and 24 months after the procedure. The incidence of complications, anesthesia dolorosa, weakness of muscles of mastication, numbness, and technical complications, was evaluated after the procedure. Results: Excellent pain relief was achieved after 6, 12, and 24 months, respectively in 95%, 85%, and 70% of patients with CCPRF; 75%, 75%, and reduced to 50% among patients with CRF; and 82%, reduced to 9.1%, and 0% of patients with PRF. No complications were recorded in 75% of patients in the CCPRF and PRF groups. There was one case of anesthesia dolorosa, 4 cases of masseter muscle weakness, and 5 cases of severe numbness recorded in the CRF group. Limitation: There was a small number of patients in each group. Conclusion: The best results were observed in the CCPRF group, followed by the CRF group, and then the PRF group.

scholarly journals Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001040 ◽  
Author(s):  
Vibeke Strand ◽  
Eduardo Mysler ◽  
Robert J Moots ◽  
Gene V Wallenstein ◽  
Ryan DeMasi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Controlled Trial ◽  
Inadequate Response ◽  
Link Type ◽  
Combination Treatments ◽  
Sf 36 ◽  
Patient Reported ◽  
Phase Iiib

ObjectiveTo provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).MethodsORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.ResultsSubstantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.ConclusionTreatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.Trial registration numberNCT02187055.

Masticatory Dysfunction After Computed Tomography–Guided Plasma Ablation vs. Radiofrequency Ablation on Gasserian Ganglion for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial

Pain Medicine ◽  
2020 ◽  
Author(s):  
Shuyue Zheng ◽  
Xiuhua Li ◽  
Liqiang Yang ◽  
Liangliang He ◽  
Guoqing Cao ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Trigeminal Neuralgia ◽  
Activity Index ◽  
Controlled Trial ◽  
Gasserian Ganglion ◽  
Idiopathic Trigeminal Neuralgia ◽  
Plasma Ablation ◽  
Masseter Muscles ◽  
Maximum Voltage ◽  
Anterior Temporalis

Abstract Objective We aimed to evaluate masticatory dysfunction after two different types of ablation on the Gasserian ganglion for the treatment of idiopathic trigeminal neuralgia. We hypothesized that low-temperature plasma radiofrequency ablation (LTP-RFA) was noninferior to radiofrequency thermocoagulation (RFT) with respect to initial efficacy. Methods In the randomized, single-blind, parallel-group, noninferiority trial, 204 participants with idiopathic trigeminal neuralgia were randomly allocated to receive plasma ablation in the LTP-RFA group and radiofrequency ablation in the RFT group in a 1:1 ratio, with random block sizes of four or six. Participants were examined at baseline (T0), on the day of discharge (T1), and at the 6-month follow-up (T2). The primary end point was the clinincal effective rate in the LTP-RFA group compared with that in the RFT group after intervention on the day of discharge. Noninferiority was prespecified at -10%. Results The intention-to-treat analysis revealed that the initial efficacy rates were 91.2% in LTP-RFA group and 93.1% in RFT group (rate ratio [RR] = 0.979, 95% confidence interval [CI]: 0.904–1.061, P = 0.795). The difference between the two groups was 1.9% (95% CI: -5.6% to 9.4%), which showed that LTP-RFA demonstrated noninferiority compared with RFT in initial efficacy. Compared with the RFT group, the LTP-RFA group exhibited a significantly greater improvement in the maximum voltage of the masseter muscles with mean differences of 11.40 (95% CI: 10.52 to 12.27, P &lt; 0.001) at T1 and 17.41 (95% CI: 14.68 to 20.13, P &lt; 0.001) at T2, respectively. Similar results were observed for the asymmetry index of occlusion, the maximum voltage of the anterior temporalis, and the activity index of anterior temporalis / masseter muscles. No serious adverse events were observed in either group. Conclusions Compared with the RFT group, noninferior efficacy for pain relief and improvement of masticatory function was revealed in the LTP-RFA group.

scholarly journals Improved pain, physical functioning and health status in patients with rheumatoid arthritis treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomised, double-blind, placebo-controlled trial

2009 ◽  
Vol 69 (2) ◽  
pp. 413-416 ◽  
Author(s):  
J H Coombs ◽  
B J Bloom ◽  
F C Breedveld ◽  
M P Fletcher ◽  
D Gruben ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Health Status ◽  
Short Form ◽  
Controlled Trial ◽  
Health Assessment ◽  
Janus Kinase ◽  
Inadequate Response ◽  
Double Blind ◽  
Sf 36 ◽  
Factor Α

Objectives:To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor α inhibitor.Methods:Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks’ follow-up. The patient’s assessment of arthritis pain (pain), patient’s assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded.Results:At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (⩾0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components.Conclusions:CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.

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