A Pilot Study of the Government Pharmaceutical Organization (GPO) Cannabis Extract for Multiple Sclerosis (MS) Spasticity Treatment in Thailand

2021 ◽  
Vol 104 (3) ◽  
pp. 460-465
Keyword(s):  
Multiple Sclerosis ◽  
Pilot Study ◽  
Rating Scale ◽  
Final Analysis ◽  
Numeric Rating Scale ◽  
Secondary Outcome ◽  
Pharmaceutical Organization ◽  
Cannabis Extract ◽  
The Government ◽  
Numeric Rating

Background: The prevalence of spasticity in multiple sclerosis (MS) patients is nearly 90%. Most patients do not respond to current anti-spastic medications. Objective: To evaluate the efficacy and safety of Government Pharmaceutical Organization cannabis extract (GPOCE) in the treatment of spasticity in MS patients in Thailand. Materials and Methods: This prospective pilot study in patients diagnosed with MS whose spasticity was not relieved under current spasticity treatments, was performed between November 2019 and June 2020. The GPOCE formulation of THC:CBD 1:1 was administered to all patients. The treatment outcomes were determined at 12 weeks and compared with their baseline. Results: Seven patients participated in the present study. Among these, two patients withdrew after receiving only a small dose of GPOCE. Finally, five patients were included in the final analysis. The primary outcome was a reduction in the Modified Ashworth Score (MAS), which decreased among participants from a baseline of 15 (IQR 12 to 19) to 6 (IQR 1 to 12) (p=0.043). The key secondary outcome was a clinically relevant response (CRR), which was defined as a reduction of the spasticity Numeric Rating Scale (NRS) of more than thirty percent compared to baseline. Four patients (80%) achieved CRR. Moreover, the overall spasticity NRS decreased from a median of 6 (IQR5 to 7) to 2 (IQR2 to 3). A reduction of other NRS parameters, including fatigue, pain, tremor, sleep, spasm, anxiety, and depression, was also observed after treatment. Moreover, GPOCE was generally well tolerated. Conclusion: GPOCE is useful in treating spasticity in patients with MS. The safety profile is acceptable under the supervision of a health care provider. Keywords: Multiple sclerosis (MS), Cannabis extract, Spasticity

scholarly journals Extended Duration Regional Analgesia for Total Knee Arthroplasty: A Randomised Controlled Trial Comparing Five Days to Three Days of Continuous Adductor Canal Ropivacaine Infusion

2018 ◽  
Vol 46 (3) ◽  
pp. 326-331 ◽  
Author(s):  
S. C. Sargant ◽  
M. J. Lennon ◽  
R. J. Khan ◽  
D. Fick ◽  
H. Robertson ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Rating Scale ◽  
Intervention Group ◽  
Numeric Rating Scale ◽  
Secondary Outcome ◽  
Quality Of Recovery ◽  
Adductor Canal ◽  
Total Knee ◽  
Numeric Rating

There is a growing body of evidence in favour of continuous adductor canal block (CACB) for total knee arthroplasty. However, there are no studies describing the optimal duration of the infusion. At our institution the usual practice was to stop the infusion on day three. Our hypothesis was that extending the infusion to five days would improve analgesia and quality of recovery. A prospective, non-blinded, randomised trial was undertaken. Patients received a continuous infusion of 0.2% ropivacaine via an adductor canal catheter for either three or five days. Primary outcome was pain while walking during the 24-hour period up to day five (numeric rating scale from 0 to 10). The minimum clinically important difference was set at 1.5 on the numeric rating scale. Secondary outcome measures included quality of recovery, mobility, pain while walking on postoperative day six, Oxford Knee Scores, and complications. Eighty-six patients were recruited with 43 randomised to each group. Seventy-eight were analysed. Median pain scores reported on day five were significantly better in the intervention group (1 versus 3, P=0.003). Furthermore, quality of recovery (QOR-15) scores were significantly better in the intervention group (133.6 versus 123.4, P=0.017). No statistically significant difference between groups was identified for other secondary outcome measures. CACB prolonged to five days provides superior analgesia and a higher quality of recovery on postoperative days four and five compared to a three-day infusion. This benefit did not extend beyond the period of infusion.

scholarly journals A Pilot Study of the Correlation between the Numeric Rating Scale used to Evaluate "Geop" and Questionnaires on Pain Perception

2015 ◽  
Vol 28 (1) ◽  
pp. 32 ◽  
Author(s):  
Bon Sung Koo ◽  
Myung Jin Jung ◽  
Joon Ho Lee ◽  
Hee Cheol Jin ◽  
Jeong Seok Lee ◽  
...  
Keyword(s):  
Pilot Study ◽  
Pain Perception ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Numeric Rating

scholarly journals Endoscope-Assisted Minimally Invasive Interlaminar Lumbar Decompression for Spinal Stenosis

2019 ◽  
Vol 6 (22;6) ◽  
pp. E573-E578
Author(s):  
Chan Hong Park
Keyword(s):  
Rating Scale ◽  
Numeric Rating Scale ◽  
Secondary Outcome ◽  
Lumbar Stenosis ◽  
Lumbar Decompression ◽  
Pain Scores ◽  
Number Of Patients ◽  
Study Setting ◽  
Numeric Rating

Background: Lumbar stenosis is characterized by a narrowing of the spinal canal in association with progressive degenerative changes in the lumbar spine and surrounding structures, including hypertrophy of the ligamentum flavum (LF). Objectives: The aim of this study was to examine the usefulness of endoscope-assisted interlaminar lumbar decompression (EILD) for patients with lumbar stenosis and hypertrophy of the LF. Study Design: Retrospective study. Setting: Department of Anesthesiology and Pain Medicine, Neurosurgery at Wooridul Spine Hospital. Methods: A total of 51 patients were enrolled in this study. Outcomes were evaluated at baseline and at 2 weeks and 6 months postprocedure via the Numeric Rating Scale, Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Results: Mean posttreatment pain scores at 2 weeks and 6 months were significantly lower, and ODI scores were significantly decreased compared with baseline. ZCQ scores were also significantly decreased compared with pretreatment surveys. Two patients required reoperation within one month. At postprocedure 6 months, a ≥ 50% reduction in pain score was recorded in 26 (80%) of 51 patients, and there was ≥ 40% reduction in ODI score in 82% of patients. No serious complications including epidural bleeding, dural or neural injuries, or infection were recorded. Limitations: This study lacked secondary outcome substantiation. In addition, the follow-up period was short (< 6 months), and no patients had postprocedure magnetic resonance imaging. The number of patients was also small. Conclusions: EILD provided good outcomes and may be a reasonable treatment option for carefully selected patients with hypertrophy of the LF.

Effect of Minocycline on Lumbar Radicular Neuropathic Pain

2015 ◽  
Vol 122 (2) ◽  
pp. 399-406 ◽  
Author(s):  
Pascal Vanelderen ◽  
Jan Van Zundert ◽  
Tamás Kozicz ◽  
Martine Puylaert ◽  
Pieter De Vooght ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Confidence Interval ◽  
Rescue Medication ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Pain Questionnaire ◽  
Numeric Rating

Abstract Background: Less than 50% of patients experience sufficient pain relief with current drug therapy for neuropathic pain. Minocycline shows promising results in rodent models of neuropathic pain but was not studied in humans with regard to the treatment of neuropathic pain. Methods: In this randomized, double-blind, placebo-controlled clinical trial, patients with subacute lumbar radicular pain received placebo, amitriptyline 25 mg, or minocycline 100 mg once a day (n = 20 per group) for 14 days. Primary outcome measure was the pain intensity in the leg as measured by a numeric rating scale ranging from 0 to 10 on days 7 and 14. Secondary outcome measures were the reduction of neuropathic pain symptoms in the leg as determined with a neuropathic pain questionnaire, consumption of rescue medication, and adverse events on days 7 and 14. Results: Sixty patients were randomized and included in an intention-to-treat analysis. After 14 days, patients in the minocycline and amitriptyline groups reported a reduction of 1.47 (95% confidence interval, 0.16–2.83; P = 0.035) and 1.41 (95% confidence interval, 0.05–2.78; P = 0.043), respectively, in the numeric rating scale compared to the placebo group. No differences were seen in the neuropathic pain questionnaire values at any time point during treatment between the three groups. The rate of adverse events in the amitriptyline group was 10% versus none in the minocycline and placebo groups. No differences were noted in the consumption of rescue medication. Conclusions: Although both groups differed from placebo, their effect size was small and therefore not likely to be clinically meaningful.

scholarly journals Mouthpiece ventilation in the management of dyspnea: A single-arm pilot study

2020 ◽  
Vol 34 (9) ◽  
pp. 1274-1278
Author(s):  
Juho T Lehto ◽  
Sirpa Leivo-Korpela ◽  
Tarja Korhonen ◽  
Heidi A Rantala ◽  
Hanna Raunio ◽  
...  
Keyword(s):  
Palliative Care ◽  
Pilot Study ◽  
Visual Analogue Scale ◽  
Adverse Events ◽  
Confidence Interval ◽  
Analogue Scale ◽  
Rating Scale ◽  
Advanced Disease ◽  
Numeric Rating Scale ◽  
Numeric Rating

Background: Noninvasive ventilation may relieve dyspnea in advanced diseases, but noninvasive ventilation through mouthpiece has not been tested in palliative care. Aim: To assess the feasibility of mouthpiece ventilation in relieving dyspnea among patients with advanced disease. Design: In this prospective single-arm pilot study, the change in dyspnea by mouthpiece ventilation was measured with numeric rating scale (0–10) and 100-mm visual analogue scale. Overall, benefit and adverse events of the therapy were also assessed. Setting/participants: Twenty-two patients with an advanced disease and dyspnea from the Tampere University Hospital or Pirkanmaa Hospice were treated with mouthpiece ventilation. The patients used mouthpiece ventilation as long as they preferred, but for a minimum of 5 min. Results: After the treatment period lasting a median of 13.5 min, mean decrease in dyspnea was −1.1 (95 % confidence interval = −2.2 to −0.1, p = 0.034) on numeric rating scale and −11.8 mm (95 % confidence interval = −19.9 to −3.7, p = 0.006) on visual analogue scale. Nonetheless, there was a high variability in this effect between individual patients. About half of the patients found mouthpiece ventilation beneficial. No serious adverse events occurred, but dry mouth was the most common adverse event. Anxiety did not increase with mouthpiece ventilation. Conclusion: Mouthpiece ventilation is feasible and may relieve dyspnea in some patients with an advanced disease. Further studies are needed, and these might concentrate on stable patients in early palliative care. Before initiation, this study was registered at clinicaltrials.gov (study no. NCT03012737).

scholarly journals A Short-Term, Multidisciplinary, Intensive Inpatient Neurorehabilitation Program for Multiple Sclerosis Patients with Moderate Disability: A Pilot Study

2010 ◽  
Vol 12 (2) ◽  
pp. 66-70 ◽  
Author(s):  
José A. Cabrera-Gómez ◽  
Yanely Real-González ◽  
Roberto Díaz-Márquez ◽  
Alexander Echemendia del Valle ◽  
Alina González-Quevedo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Pilot Study ◽  
Outcome Measures ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Short Term ◽  
Good Tolerability ◽  
Multiple Sclerosis Patients

Intensive inpatient neurorehabilitation may be an effective form of intervention for people with multiple sclerosis (MS) to supplement treatment with disease-modifying agents. The primary objective of this study was to evaluate the tolerability and safety of a personalized, one-on-one, short-term, intensive inpatient neurorehabilitation program for MS patients with moderate disability. Thirty MS patients (diagnosed using Polman criteria) with moderate disability as indicated by Expanded Disability Status Scale (EDSS) score of 5.0 to 6.5 were enrolled in a 4-week intensive inpatient neurorehabilitation program. The primary outcome measures were tolerability and safety. Secondary outcome measures were impairment, disability/activity, handicap/participation, fatigue, and quality of life. The results showed good tolerability, with only three patients (10%) developing transitory neuromuscular fatigue; and safety, with adverse events observed in only six patients (20%). Significant improvement was found in impairment and disability/activity as measured by the Scripps Neurological Rating Scale (P = .000) and the EDSS (P = .001), respectively. The Multiple Sclerosis Quality of Life–54 showed improvement in physical (P = .008) and mental health (P = .026), and the Fatigue Impact Scale showed improvement in fatigue (17 patients) (P = .005). This pilot study demonstrated good tolerability and safety of the short-term inpatient intensive neurorehabilitation program. Impairment, disability/activity, quality of life, and fatigue were improved at the completion of the program. Sustained improvement remains to be determined in future clinical trials.

Foot Massage Menurunkan Nyeri Post Operasi Sectio Caesarea Pada Post Partum

2020 ◽  
Vol 6 (2) ◽  
pp. 164-170
Author(s):  
Dewi Nurlaela Sari ◽  
Aay Rumhaeni
Keyword(s):  
Daily Living ◽  
Rating Scale ◽  
Post Partum ◽  
Numeric Rating Scale ◽  
Sectio Caesarea ◽  
P Value ◽  
Test Design ◽  
Purposive Sampling ◽  
Post Test ◽  
Numeric Rating

ABSTRAK Sectio caesarea merupakan tindakan alternatif dalam proses persalinan untuk menyelamatkan ibu dan janin. Ibu Bersalin dengan operasi sectio caesarea dilakukan pembedahan pada dinding abdomen dan dinding rahim. Dampak yang paling sering muncul dirasakan oleh postpartum dengan post operasi sectio caesarea adalah  nyeri. Nyeri akan berdampak pada bounding attachment terganggu, mobilisasi terbatas, Activity Daily Living (ADL) terganggu serta berpengaruh  terhadap Inisiasi Menyusui Dini (IMD). Asuhan yang diberikan terbatas pada terapi farmakologi dibandingkan  non farmakologi. Foot massage adalah salah satu terapi non farmakologi yang dapat membantu menutup gerbang di posterior horns dari sumsum tulang belakang dan memblokir bagian dari nyeri ke sistem saraf pusat. Tujuan penelitian ini untuk mengetahui pengaruh foot massage terhadap skala nyeri pada klien post operasi sectio caesarea di RS AMC. Penelitian ini merupakan penelitian pre eksperimen dengan pendekatan one group pre test post test design. Jumlah sampel yang digunakan berjumlah 27 orang dengan menggunakan teknik purposive sampling. Instrumen yang digunakan adalah Numeric Rating Scale (NRS) dan prosedur kerja foot massage. Responden dilakukan foot massage selama 20 menit selama 2 hari. Data di analisis dengan menggunakan uji wilcoxon. Hasil penelitian menunjukkan lebih dari setengah klien post operasi sectio caesarea berada di skala nyeri 6 sebelum dilakukan foot massage dan hampir setengah memiliki skala nyeri 3 sesudah dilakukan foot massage dan didapatkan nilai p value = 0.000, sehingga disimpulkan ada pengaruh foot massage terhadap skala nyeri pada klien post operasi sectio caesarea. Diharapkan rumah sakit dapat menjadikan foot massage sebagai salah satu alternatif manajemen non farmakologi dalam penanganan nyeri.   Kata kunci: Foot Massage; Post Partum; Nyeri; Sectio Caesarea      

Efektivitas pencucian luka menggunakan daun jambu biji terhadap tingkat malodor klien luka kaki diabetik

2019 ◽  
Vol 8 (2) ◽  
pp. 152
Author(s):  
Adi Antoni ◽  
Yanna Wari Harahap
Keyword(s):  
Diabetic Foot ◽  
Rating Scale ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Numeric Rating Scale ◽  
P Value ◽  
Consecutive Sampling ◽  
Guava Leaves ◽  
Guava Leaf ◽  
Numeric Rating

Abstrak   Latar belakang: Diabetes mellitus (DM) merupakan penyakit kronik dan menjadi masalah global. Salah satu komplikasi yang ditimbulkan dari DM adalah luka kaki diabetic. Langkah awal dalam perawatan luka kaki diabetic adalah mencuci luka. Tujuan penelitian ini adalah mengetahui keefektifan dari rebusan daun jambu biji sebagai cairan pencuci luka terhadap tingkat malodor pada luka kaki diabetic. Metode: Desain penelitian yang digunakan adalah quasy experiment dengan rancangan one group pretests-posttest only. Teknik sampling yang digunakan adalah consecutive sampling dengan jumlah sampel 16 orang. Kriteria sampel yang digunakan adalah klien luka kaki diabetic, tingkat malodor 1-10 dengan NRS. Alat ukur yang digunakan adalah Numeric Rating Scale (NRS). Analisa data yang digunakan dalam penelitian ini menggunakan uji paired t test. Hasil: tingkat malodor sebelum intervensi pencucuan luka menggunakan rebusan daun jambu biji rata-rata sebesar 4.40 dan sesudah intervensi sebesart 2.44 dengan p value < 0.001. Selisih tingkat malodor antara sebelum dan sesudah intervensi sebesar 1.96. Hasil penelitian ini menunjukkan bahwa daun jambu dapat digunakan sebagai cairan pencuci luka dalam mengatasi tingkat malodor pada luka kaki diabetik. Kesimpulan : daun jambu biji dapat digunakan sebagai cairan pencuci luka pada luka kaki diabetic. Perawat diharapkan dapat memanfaatkan daun jambu biji sebagai salah satu alternatif dalam pencucian luka kronik khususnya luka kaki diabetik.   Kata kunci: Daun Jambu Biji, Tingkat Malodor, Luka Kaki Diabetik   Abstract   Background: Diabetes mellitus (DM) is a chronic disease and a global problem. One of the complications that arise from DM is diabetic foot ulcer. The first step in treating diabetic foot ulcer is washing the wound. The purpose of this study was to determine the effectiveness of guava leaf decoction as a washing fluid for malodor levels in diabetic foot ulcer. Method: The research design used was quasy experiment with one group pretests-posttest only design. The sampling technique used was consecutive sampling with a sample of 16 people. Sample criteria used were diabetic foot ulcer clients, malodor level 1-10 with NRS. The measuring instrument used is the Numeric Rating Scale (NRS). Analysis of the data used in this study used paired t test. Results: the level of malodor before intervening in wound washing using guava leaf decoctions on average was 4.40 and after the intervention was 2.44 with p value <0.001. The difference in the level of malodor between before and after the intervention was 1.96. The results of this study indicate that guava leaves can be used as a washing fluid in dealing with malodor levels in diabetic foot ulcer. Conclusion: Guava leaves can be used as a washing fluid for diabetic foot wounds. Nurses are expected to be able to use guava leaves as an alternative in washing chronic wounds, especially diabetic foot injuries.   Key words: Guava Leaf, Malodor Level, Diabetic foot ulcer.

scholarly journals RCT on the effectiveness of the intraligamentary anesthesia and inferior alveolar nerve block on pain during dental treatment

2021 ◽  
Author(s):  
Bahaa R. Youssef ◽  
Andreas Söhnel ◽  
Alexander Welk ◽  
Mohamed H. Abudrya ◽  
Mohamed Baider ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Nerve Block ◽  
Rating Scale ◽  
Dental Treatment ◽  
Inferior Alveolar Nerve ◽  
Numeric Rating Scale ◽  
Inferior Alveolar Nerve Block ◽  
Posterior Teeth ◽  
Mandibular Posterior Teeth ◽  
Numeric Rating

Abstract Objective To compare the effectiveness and complications of intraligamentary anesthesia (ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental treatment of mandibular posterior teeth. Materials and methods In this randomized, prospective clinical trial, 72 patients (39 males, 33 females), scheduled for dental treatment of mandibular posterior teeth, were randomly allocated to ILA group (n = 35) received ILA injection or IANB group (n = 37) received the conventional IANB. Our primary outcome was to assess pain and stress (discomfort) during the injection and dental treatment, using the numeric rating scale (NRS) from 0 to 10 (0 = no pain, 10= the worst pain imaginable), whereas recording 24-h postoperative complications was our secondary outcomes. Results Patients in ILA group reported significantly less pain during injection when compared with IANB group (p = 0.03), while pain during dental treatment was similar in both groups (p = 0.2). Patients in both groups also reported similar law values of discomfort during treatment (p = 0.7). Although no signs of nerve contact or any other postoperative complications were observed, five patients in IANB group (none in ILA group) reported temporary irritations. Conclusion This study showed equivalent effectiveness of both intraligamentary anesthesia and conventional inferior alveolar nerve block, for pain control during routine dental treatment of mandibular posterior teeth. Nevertheless, ILA showed significantly less pain during injection. No major postoperative complications in both groups were observed. Clinical relevance ILA could be considered as an effective alternative for routine dental treatment. Trial registration NCT04563351

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