scholarly journals Impact of treatment dose on patient outcomes after Interdisciplinary Multimodal Pain Therapy

Author(s):  
Philipp Baumbach ◽  
Maria Richter ◽  
Johannes Schneider ◽  
Ulrich Christian Smolenski ◽  
Thomas Weiss ◽  
...  

Abstract Objectives The impact of duration and intensity on outcomes after Interdisciplinary Multimodal Pain Therapy (IMPT) is poorly researched. The aim of this study was to compare the effects of low dose (LD, avg. 25 hours) and high dose IMPT (HD, avg. 110 hours).Methods Patients completed pain-related questionnaires at the beginning (T1), at the end of therapy (T2) and at 3-month follow-up (T3) and were matched according to age, sex, presence of back-pain and pain-related disability at T1, resulting in 32 patients per group. Primary endpoint was the difference in pain-related disability and average pain intensity at T3 between both groups. In addition, early treatment effects and group differences at T2 were analyzed.Results Both groups showed significant improvements in pain-related disability and average pain intensity between T1 and T2. These positive effects persisted in the HD group until the 3-month follow-up, whereas outcomes in the LD group patients deteriorated and were significantly poorer compared to HD at T3.Discussion Within a widely comparable therapeutic setting, high-dose IMPT was associated with longer lasting improvements compared to low-dose IMPT in chronic pain patients, indicating that the “dose” of therapy is a relevant factor for clinical outcomes and should be further investigated.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karin Due Bruun ◽  
Kirstine Amris ◽  
Henrik Bjarke Vaegter ◽  
Morten Rune Blichfeldt-Eckhardt ◽  
Anders Holsgaard-Larsen ◽  
...  

Abstract Background Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia. Methods A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18–64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers. Discussion This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia. Trial registration EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020


2021 ◽  
Author(s):  
Karin Due Bruun ◽  
Kirstine Amris ◽  
Henrik Bjarke Vaegter ◽  
Morten Rune Blichfeldt-Eckhardt ◽  
Anders Holsgaard-Larsen ◽  
...  

Abstract Background Low dose naltrexone (LDN) is used widely as off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last seven days in women with fibromyalgia.Methods A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18–64 years and diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a four-week titration phase. The primary outcome is change in average pain intensity (during the last seven days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e. tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers.Discussion This study will contribute with high-level evidence on the efficacy of low dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia.Trial registration: EudraCT number 2019-000702-30 (registered on 2019-07-12). ClincalTrials.gov Identifier: NCT04270877 (registered on 2020-02-17).


2020 ◽  
Vol 52 (12) ◽  
pp. 841-849
Author(s):  
Chunmei Xu ◽  
Ping Wang ◽  
Huikai Miao ◽  
Tianyue Xie ◽  
Xiaojun Zhou ◽  
...  

AbstractA potential reduction of goiter volume (GV) of recombinant human thyrotropin (rhTSH) on multinodular goiters (MNG) was previously reported but controversial. Hence we conducted a meta-analysis to estimate the effect of rhTSH-stimulated radioiodine therapy in patients with MNG. PubMed, Cochrane, CNKI, VIP, and Wanfang databases were searched. Mean difference (MD) and odds ratios with 95% confidence intervals (95% CI) were derived by using an inverse variance random-effects model and fixed-effects model, respectively. Six studies (n=237) were involved in the analysis. For 12 months follow up, high dose (>0.1 mg) of rhTSH significantly reduced GV (MD=17.61; 95% CI=12.17 to 23.04; p<0.00001) compared with placebo. No effective pooled results of low dose of rhTSH (<0.1 mg) were applicable for only one study included. For 6 months follow up, the source of heterogeneity was determined by subgroup and sensitivity analysis. High dose group showed vast improvement in GV reduction (MD=16.62; 95% CI=1.34 to 31.90; p=0.03). The reduction of low dose group compared with placebo was inferior to high dose group. No available data were obtained to assess the influence of rhTSH after 36 months follow up for the only included study. Hypothyroidism incidence was higher for rhTSH group. No publication bias was seen. High dose of rhTSH treatment-stimulated radioactive 131I therapy after 6 months and 12 months follow up had a better effect in reducing GV, but with higher incidence of hypothyroidism. Owing to the limited methodological quality, more clinical researches are warranted in the future.


2014 ◽  
Vol 41 (2) ◽  
pp. 92-98 ◽  
Author(s):  
Ilario Froehner Junior ◽  
Paulo Gustavo Kotze ◽  
Juliana Gonçalves Rocha ◽  
Eron Fábio Miranda ◽  
Maria Cristina Sartor ◽  
...  

OBJECTIVE: To evaluate the effects of topical policresulen and cinchocaine in the postoperative pain behavior of open hemorrhoidectomy.METHODS: We conducted a prospective, double-blinded, controlled study. The control group received the usual guidelines with oral medications. The topical treatment group received, in addition, the application of the ointment and was comprised of two subgroups (policresulen + cinchocaine, and placebo). Pain intensity was recorded with the visual analogue scale.RESULTS: 43 patients were operated on: control group - n = 13, one excluded; placebo - n = 15; and policresulen + cinchocaine - n = 15. The mean age was 45.98 years and 37.2% were men. The average pain intensity was 4.09 (immediate postoperative), 3.22 (hospital discharge), 5.73 (day 1) , 5.77 (day 2), 5.74 (day 3), 5.65 (day 7), 5.11 (day 10), 2.75 (day 15) and 7.70 (first bowel movement), with no difference between groups in all periods.CONCLUSION: This study showed no reduction in pain after hemorrhoidectomy with the use of topical policresulen and cinchocaine.


2004 ◽  
Vol 26 (4) ◽  
pp. 610-615 ◽  
Author(s):  
Britton W. Brewer ◽  
Allen E. Cornelius ◽  
Judy Van Raalte ◽  
John C. Brickner ◽  
Howard Tennen ◽  
...  

The accuracy of retrospective ratings of pain intensity was examined in a sample of 72 men and 36 women undergoing rehabilitation following anterior cruciate ligament (ACL) reconstructive surgery. Participants completed daily ratings of current, worst, and average pain intensity for the first 42 days of rehabilitation. Participants provided retrospective ratings of worst and average pain intensity twice for a 7-day period (on Days 7 and 21) and once for a 30-day period (on Day 30). Correlations between concurrent and retrospective pain ranged from .74 to .88. Retrospective pain ratings consistently overestimated concurrent pain ratings, but were generally not biased by current pain. The results suggest that retrospective pain ratings can substitute for concurrent pain ratings if the tendency toward overestimation is taken into account.


Pain ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Henrik Heitmann ◽  
Cristina Gil Ávila ◽  
Moritz M. Nickel ◽  
Son Ta Dinh ◽  
Elisabeth S. May ◽  
...  

2019 ◽  
Vol 301 (1) ◽  
pp. 69-73 ◽  
Author(s):  
Mauricio La Rosa ◽  
Chasey Omere ◽  
Tiffany Redfern ◽  
Mahmoud Abdelwahab ◽  
Nicholas Spencer ◽  
...  

Author(s):  
Robert Ross ◽  
Brian Fuehrlein

This chapter provides a summary of a landmark study on substance use disorders. Which of the following is most effective for treatment of opioid dependence: levomethadyl acetate, buprenorphine, high-dose methadone, or low-dose methadone? Starting with that question, it describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. The study demonstrates that buprenorphine, high-dose methadone, and levomethadyl acetate are equally effective in the treatment of opiate use disorder. All three treatments are significantly more effective than low-dose methadone.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Sarah E Hodges ◽  
Shervin Rahimpour ◽  
Luis Alejandro Antezana ◽  
Abena A Ansah-Yeboah ◽  
Rajeev Dharmapurikar ◽  
...  

Abstract INTRODUCTION Various new waveforms for spinal cord stimulation (SCS) have emerged in recent years, with limited data supporting their utility in a real-world clinical setting. We report real-world results of a protocolized workflow algorithm that allows for high dose (HD) and low dose (LD) neurostimulation in patients with chronic pain undergoing SCS trial or permanent procedures. METHODS Prospective data was collected using the ManageMySurgery (MMS) mobile device platform in patients undergoing Medtronic SCS trial and permanent implant procedures. E-consent was obtained through the HIPAA compliant, mobile software platform. All data was de-identified, aggregated and analyzed. RESULTS In total, 104 patients (37 trial SCS and 67 permanent SCS) participated. For SCS trial and permanent procedures, the protocolized workflow algorithm resulted in a 91% trial success rate with >50% pain relief. At long-term follow-up (3 to 12 mo), 86% of permanent SCS patients reported they were getting the same or more relief as during their SCS trial. For permanent SCS patients, 79% reported >50% improvement in overall pain and 58% had >50% improvement in low back pain. The protocolized workflow algorithm resulted in a 37% “remitter rate,” with these patients reporting themselves essentially pain free (VAS 0–3). Importantly, 52% of permanent implant patients stopped or reduced their ‘as needed’ pain medications by >50%. Additionally, 87% would recommend the same procedure to a friend or family member, 87% found device charging ‘easy’ or ‘very easy’ and 66% reported charging a few times a week or weekly. CONCLUSION A protocolized workflow algorithm that allows for HD and LD neurostimulation appears to have robust utility in providing meaningful pain relief and opiate reduction during both the SCS trial and permanent stages and at longer-term follow-up. Randomized controlled trials with extended follow-up are in progress.


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