scholarly journals Perioperative Gabapentin in Pediatric Thoracic Surgery Patients—Randomized, Placebo-Controlled, Phase 4 Trial

Pain Medicine ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. 1562-1571 ◽  
Author(s):  
Lucyna Tomaszek ◽  
Dariusz Fenikowski ◽  
Piotr Maciejewski ◽  
Halina Komotajtys ◽  
Danuta Gawron
Keyword(s):  
Patient Satisfaction ◽  
Placebo Group ◽  
Side Effects ◽  
Thoracic Surgery ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Care Providers ◽  
Significant Difference ◽  
Group 6 ◽  
Ravitch Procedure

Abstract Objective To determine whether the use of perioperative gabapentin reduces postoperative pain and anxiety, decreases ropivacaine consumption and side effects, and improves patient satisfaction. Design Randomized, placebo-controlled, phase 4 trial. Blinding Participants, care providers, investigators, data analysts. Setting Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch, Poland. Subjects Forty patients undergoing the Ravitch procedure. Methods Patients aged nine to 17 years were randomized into a gabapentin (preoperative 15 mg/kg, treatment) or placebo group. Postoperative analgesia included gabapentin (7.5 mg/kg) or placebo two times per day for three days, epidural ropivacaine + fentanyl, paracetamol, nonsteroidal anti-inflammatory drugs, and metamizol as a “rescue drug.” Pain, anxiety, analgesic consumption, side effects, and patient satisfaction were recorded. Results There was no statistically significant difference in median pain scores (numerical rating scale < 1/10) or incidence of adverse side effects between the gabapentin group (N = 20) and the placebo group (N = 20). Postoperative anxiety scores were significantly lower than before surgery in the gabapentin group (6 [4–8] vs 7 [6–8.5], P < 0.01) and remained unchanged in the placebo group (6 [5–6.5] vs 6 [5–7], P = 0.07). Gabapentin-treated patients received a lower number of doses of ondansetron when compared with the placebo group (6 [5–6] vs 7 [6–9], P = 0.02). A significant negative association was found between patient satisfaction and postoperative state anxiety in the gabapentin group (R = –0.51, P = 0.02). Conclusions Perioperative administration of gabapentin resulted in a decrease of postoperative anxiety in pediatric patients undergoing the Ravitch procedure.

scholarly journals Comparison of efficacy and safety of oxycodone versus fentanyl for intravenous patient-controlled analgesia in postoperative pain management: a systematic review and meta-analysis

2019 ◽  
Author(s):  
Peng Chen ◽  
Fuchao Chen ◽  
Jiexin Lei ◽  
zhou benhong
Keyword(s):  
Patient Satisfaction ◽  
Postoperative Pain ◽  
Pain Relief ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Meta Analysis ◽  
Postoperative Pain Relief ◽  
Cochrane Library ◽  
Patient Controlled Analgesia ◽  
Significant Difference

Abstract Backgroud Patient-controlled analgesia(PCA) with intravenous an opioid has been suggested as a effective method of postoperative pain relief. There are several randomized controlled trials (RCTs) of comparison of oxycodone and fentanyl for IV-PCA in surgical patients. The purpose of this study was to performed a meta-analysis to compare the effect of intravenous oxycodone and fentanyl on post-operative pain in sugical patients from collected current data. Methods The RCTs of oxycodone versus fentanyl for IV-PCA were gathered from PubMed, Embase, Cochrane library, CNKI and VIP data. After data extraction and quality assessment of the included RCTs, the RevMan 5.3 software was applied for meta-analysis of numerical rating scale (NRS) scores, accumulated IV-PCA consumption of oxycodone and fentanyl, patient satisfaction, postoperative nausea and vomiting (PONV), and other adverse events (AEs). Results Results reported from eight RCTs involving 600 patients are included in the meta-analysis. The NRS score at rest and upon movement of group oxycodone was significantly lower than that of group fentanyl (WMD= -3.85, 95% CI -4.93~-2.76, P<0.00001; WMD= -4.31, 95% CI -5.79~-2.84, P<0.00001); however, the incidence of PONV and dizziness was significantly higher in group oxycodone than in group fentanyl (OR = 2.41, 95% CI 1.60~3.63, P < 0.0001; OR=3.69, 95% CI 2.17~6.26, P<0.00001). Accumulated IV-PCA consumption in group oxycodone was less than in group fentanyl overall the 48 hours postoperatively (WMD= -12.11, 95% CI -18.42~-5.80, P = 0.0002). There was no significant difference in patient satisfaction between oxycodone and fentanyl (OR=0.73, 95% CI 0.11~5.04, P= 0.75). Conclusion According to the evidence, this meta-analysis suggest that oxycodone IV-PCA is superior to fentanyl in postoperative pain relief, whereas the higher incidence of PONV and dizziness was accompanied with oxycodone. Further large-scale and well-designed studies are needed to summarize and analyse the data to draw a more convincing conclusion.

Effect of Perioperative Electroacupuncture as An Adjunctive Therapy on Postoperative Analgesia with Tramadol and Ketamine in Prostatectomy: A Randomised Sham-Controlled Single-Blind Trial

2014 ◽  
Vol 32 (3) ◽  
pp. 215-222 ◽  
Author(s):  
Vagia Ntritsou ◽  
Christos Mavrommatis ◽  
Christos Kostoglou ◽  
Georgios Dimitriadis ◽  
Nikolaos Tziris ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Side Effects ◽  
Postoperative Pain ◽  
Adjunctive Therapy ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Sham Acupuncture ◽  
Control Group ◽  
Rescue Analgesia ◽  
Pressure Algometer

Objectives To study the analgesic effect of electroacupuncture (EA) as perioperative adjunctive therapy added to a systemic analgesic strategy (including tramadol and ketamine) for postoperative pain, opioid-related side effects and patient satisfaction. Methods In a sham-controlled participant- and observer-blinded trial, 75 patients undergoing radical prostatectomy were randomly assigned to two groups: (1) EA (n=37; tramadol+ketamine+EA) and (2) control (n=38; tramadol+ketamine). EA (100 Hz frequency) was applied at LI4 bilaterally during the closure of the abdominal walls and EA (4 Hz) was applied at ST36 and LI4 bilaterally immediately after extubation. The control group had sham acupuncture without penetration or stimulation. The following outcomes were evaluated: postoperative pain using the Numerical Rating Scale (NRS) and McGill Scale (SF_MPQ), mechanical pain thresholds using algometer application close to the wound, cortisol measurements, rescue analgesia, Spielberger State Trait Anxiety Inventory (STAI Y-6 item), patient satisfaction and opioid side effects. Results Pain scores on the NRS and SF_MPQ were significantly lower and electronic pressure algometer measurements were significantly higher in the EA group than in the control group (p<0.001) at all assessments. In the EA group a significant decrease in rescue analgesia was observed at 45 min (p<0.001) and a significant decrease in cortisol levels was also observed (p<0.05). Patients expressed satisfaction with the analgesia, especially in the EA group (p<0.01). Significant delays in the start of bowel movements were observed in the control group at 45 min (p<0.001) and 2 h (p<0.05). Conclusions Adding EA perioperatively should be considered an option as part of a multimodal analgesic strategy.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

scholarly journals Association of Serum Serotonin and Pain in Patients with Chronic Low Back Pain before and after Spinal Surgery

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Afshin Farhanchi ◽  
Behrouz Karkhanei ◽  
Negar Amani ◽  
Mashhood Aghajanloo ◽  
Elham Khanlarzadeh ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Chronic Low Back Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Low Back ◽  
Significant Difference ◽  
Before And After ◽  
Postoperative Serum ◽  
Serum Serotonin

Introduction. In this study we are aiming to evaluate the changes of serum serotonin and its association with pain in patients suffering from chronic low back pain before and after lumbar discectomy surgery. Patients and Methods. A prospective study was performed on the patients referring to the outpatient clinic in Besat hospital, Hamadan University of Medical Sciences, Hamadan, Iran, during 2016. A 2 mL fasting blood sample was collected from each patient at preoperative day 1 and postoperative day 14 and they were measured for level of serum serotonin. Besides, all patients were asked for severity of their low back pain in preoperative day 1 and postoperative day 14 and scored their pain from zero to ten using a Numerical Rating Scale. Results. Forty patients with the mean age of 47 ± 13 yrs/old (range 25–77) including 15 (37.5%) males were enrolled into the study. The overall mean score of preoperative pain was significantly decreased from 7.4 ± 2.18 (range 4–10) to the postoperative pain score 3.87 ± 2.92 (range 0–10) (P < .001). The overall levels of pre- and postoperative serum serotonin were 3.37 ± 1.27 (range 1.1–6.4) and 3.58 ± 1.32 (range .94–7.1) ng/mL, respectively, with no significant difference (P = .09). The levels of pre- and postoperative serum serotonin were significantly higher in males and patients older than 50 yrs/old compared to the females and patients younger than 50 yrs/old, respectively (P = .03 and .005, respectively). A significant inverse correlation between the postoperative levels of pain and serum serotonin was observed (r = -.36 and P = .02). Conclusion. A negative medium strength linear relationship may exist between the postoperative serum serotonin and low back pain.

scholarly journals Selenium and functional constipation in children

2016 ◽  
Vol 56 (2) ◽  
pp. 111
Author(s):  
Marlina Tanjung ◽  
Supriatmo Supriatmo ◽  
Melda Deliana ◽  
Ade Rachmat Yudiyanto ◽  
Atan Baas Sinuhaji
Keyword(s):  
Abdominal Pain ◽  
Placebo Group ◽  
Side Effects ◽  
Functional Constipation ◽  
Causative Factor ◽  
Gastrointestinal Diseases ◽  
Average Frequency ◽  
Stool Consistency ◽  
Significant Difference ◽  
Selenium Treatment

Background Constipation is a common problem in children, with approximately 90 to 95% of constipation cases having functional constipation. Oxidative stress may be a causative factor in gastrointestinal diseases, alleved by intervention with antioxidants. Selenium is an essential trace element and acts as a cofactor of gluthathione peroxidase, which protects membranes from oxidative damage.Objective To determine the effect of selenium on functional constipation in children.Methods We conducted a single-blind, randomized clinical trial from November to December 2012 at the Al-Kautsar Al-Akbar Islamic Boarding School in Medan, North Sumatra. Subjects were children aged 12 to 17 years with functional constipation, diagnosed according to the ROME III criteria. Patients were randomly allocated into either the selenium group (n=57) or the placebo group (n=57). Subjects were clinically evaluated for frequency of defecation, stool consistency, severity of abdominal pain, and side effects during the 2 weeks of treatment (days 7 and 14) and 1 week after treatment had stopped (day 21).Results A total of 114 subjects were eligible to participate. The average frequency of defecation observed on day 14 was 1.5 (SD 0.75) days per defecation (P=0.0001) in the selenium group and 2.4 (0.84) days per defecation in the placebo group, a statistically significant difference (P=0.0001). There was no significant difference in frequency of defecation on the 7th day of treatment. But after day 7, there were significant differences between the groups at days 14 and 21. Normal stool consistency was found in 45 subjects (78.9%) on day 7 and in 57 subjects (100%) on day 14 of treatment in the selenium group, significantly more than those in the placebo group (P<0.05). In placebo group, normal stool consistency was found in 27 subject (47.4%) with (P=0.001) on day 7 and in 38 subject (66.7%) on day 14 of treatment (P=0.0001). On day 14, the selenium group had significantly more subjects without pain than the placebo group [47 subjects (82.5%) vs. 10 subjects (17.5%), respectively (P=0.0001)]. Severity of abdominal pain after 14th day of treatment is without pain 47 subject (82.5%) and mild pain 10 subject (17.5%) (P=0.0001). We found no side effects of selenium treatment in our subjects.Conclusion Selenium is effective in improving clinically functional constipation, in terms of increased frequency of defecation, normalization of stool consistency, and less severe abdominal pain.

scholarly journals Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial

2017 ◽  
Vol 10 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Katharine Hamlin ◽  
Christopher Munro ◽  
Scott L. Barker ◽  
Sean McKenna ◽  
Kapil Kumar
Keyword(s):  
Randomized Controlled Trial ◽  
Grip Strength ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Lateral Epicondylitis ◽  
Open Release ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Background Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. Methods In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. Results NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Conclusions Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

scholarly journals Clinical Efficacy of Scalene Injection for Thoracic Outlet Syndrome

2021 ◽  
Author(s):  
Samuel Baek ◽  
Seok Kim ◽  
Myung Ho Shin ◽  
Tae Min Kim ◽  
Seoung-Joon Lee ◽  
...  
Keyword(s):  
Side Effects ◽  
Clinical Efficacy ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Neck Disability Index ◽  
Vital Signs ◽  
Treatment Technique ◽  
The Novel ◽  
Numerical Rating ◽  
Neck Disability

Purpose: We introduce the novel treatment technique, scalene injection, and study its clinical efficacy for diagnosis, treatment, and pain control for patients with thoracic outlet syndrome.Methods: Between November 2001 and October 2018, 266 patients were studied retrospectively. To evaluate the efficacy and sustainability, we checked the numerical rating scale (NRS) for pain relief and neck disability index (NDI) for functional improvements, prior to and 1, 12 weeks after the injection. The safety was evaluated by examining side effects for at least 24 hours from the point of injection.Results: NRS was improved from 7.12 to 3.11 at 1 week, and to 3.05 at 12 weeks (p<0.05). NDI was improved from 15.87 to 6.15 at 1 week, and to 6.19 at 12 weeks (p<0.05). There were two cases of convulsion immediately after the injection and were treated with prompt oxygen supply and sedatives. Transient side effects included two cases of dyspnea and one case of nausea and were resolved within 1 hour after. All five cases showed symptoms of side effects on the day of injection and were resolved within a day. A total of 242 patients (91.0%) experienced immediate declines in NRS and 161 patients experienced persistent declines for more than 12 weeks. However, 24 patients (9.0%) showed no improvement and 20 patients (7.5%) experienced increases in NRS.Conclusion: Scalene injection is also effective as a therapeutic method. However, this study suggests that it must be done with monitoring of vital signs in an operating room for any possible complications and side effects.

scholarly journals Isolating peripheral effects of endogenous opioids in modulating exertional breathlessness in people with moderate or severe COPD: a randomised controlled trial

2019 ◽  
Vol 5 (4) ◽  
pp. 00153-2019 ◽  
Author(s):  
David C. Currow ◽  
Toby Hunt ◽  
Sandra Louw ◽  
Danny Eckert ◽  
Peter Allcroft ◽  
...  
Keyword(s):  
Exercise Capacity ◽  
Opioid Receptors ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Endogenous Opioids ◽  
Chronic Obstructive ◽  
Regression Slope ◽  
End Point ◽  
Significant Difference ◽  
Peripheral Opioid Receptors

Question addressed by the studyEndogenous opioids (endorphins) have been reported to modulate exercise-induced breathlessness, but the relative contribution of peripheral opioid receptors has not been tested.Materials, participants and methodsThis was a double-blind, randomised, three-arm, cross-over trial in outpatients with spirometry-verified moderate to severe chronic obstructive pulmonary disease. Participants undertook an incremental symptom-limited treadmill test followed by five endurance treadmill tests at 75% of their maximal work rate; two tests for familiarisation and three tests 30 min after intravenous injection of either methylnaltrexone 0.3 mg·kg−1 (blocking peripheral opioid receptors only) or naloxone 0.1 mg·kg−1 (blocking both central and peripheral opioid receptors) or normal saline, in randomised order. The primary end-point was the regression slope between breathlessness intensity (0–10 numerical rating scale) and oxygen consumption (V′O2) during the walk tests, comparing methylnaltrexone and placebo using a paired t-test.Results17 participants completed the trial: median (range) 66 (55–82) years; 15 males; mean±sd forced expiratory volume (FEV1) 53.8±17.6% predicted; FEV1/forced vital capacity ratio 0.55±15.9. There was no statistically or clinically significant difference in the primary end-point (regression slope of breathlessness intensity and V′O2) for methylnaltrexone (p=0.498) or naloxone (p=0.804), compared to placebo. Secondary outcomes were similar between the three treatment groups, including peak and mean breathlessness intensity and unpleasantness, exercise capacity, endurance time and leg fatigue.Answer to the questionBlocking peripheral opioid receptors (methylnaltrexone) or peripheral and central opioid receptors (naloxone) did not appear to modulate breathlessness intensity nor exercise capacity when compared with placebo (no blockade).

scholarly journals Undergraduate Students’ Acceptance of a Reciprocating One-File System for Endodontic Treatment

2020 ◽  
Vol 14 (03) ◽  
pp. 393-396
Author(s):  
Benjamin Mahmoodi ◽  
Adriano Azaripour ◽  
Kawe Sagheb ◽  
Keyvan Sagheb ◽  
Brita Willershausen ◽  
...  
Keyword(s):  
Undergraduate Students ◽  
Rating Scale ◽  
File System ◽  
Numerical Rating Scale ◽  
File Systems ◽  
Subjective Assessment ◽  
Educational Process ◽  
Undergraduate Teaching ◽  
Practical Training ◽  
Significant Difference

Abstract Objectives Reciprocating endodontic one-file systems are a comparatively new method for root canal shaping. Even though the mechanical properties are comparable to modern rotating mechanical systems, data about subjective assessment and application quality are scarce. This study evaluates the reciprocating one-file system in undergraduate education. Materials and Methods A total of 42 undergraduate students without experience regarding reciprocating file systems filled in a questionnaire in four different points in time (t 1–t 4) anonymously. The questionnaire was based on a numerical rating scale ranging from 0 to 10. Statistical Analysis A least significant difference post-hoc analysis comparing the group average values was performed. The adjusted level of significance was p < 0.004 after Bonferroni correction. Results All rating scores increased after the first theoretical instruction. After the first practical training in artificial root canals in resin blocks and extracted teeth (t 2), the estimation of “time efficiency” (p = 0.002), “handling” (p < 0.001), and “overall impression” (p < 0.001) improved significantly. The “overall impression” remained constant and showed no significant changes after the first practical training. Conclusions Reciprocating systems seem to show a good acceptance among first time users. Initial concerns about “work safety” decrease during every step of the educational process. Reciprocating one-file systems are a safe and well-accepted method in undergraduate teaching.

scholarly journals A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia

Pain Medicine ◽  
2019 ◽  
Vol 21 (2) ◽  
pp. 326-332 ◽  
Author(s):  
Hiroshi Oka ◽  
Kenji Miki ◽  
Iwao Kishita ◽  
David F Kong ◽  
Takahiro Uchida
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Repeated Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Double Blind ◽  
Point Change ◽  
Entire Treatment Period ◽  
Magnetic Field Therapy ◽  
Significant Difference

Abstract Objectives Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). Methods Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. Results The primary end point (change in NRS ± SD at week 8 vs baseline) was –0.94 ± 1.33 in the AT-02 group and –0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (–0.73, 95% confidence interval = –1.56 to 0.11, P = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P = 0.039). Conclusions The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.

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