2020 News from the Research Team Articles

October 2020

Recommendations for the surgical treatment of endometriosis.  Part 2: deep endometriosis. 
Authors: Working group of ESGE, ESHRE and WES

Article summarized by Kristie Lou, MD and Tim Deimling MD, MSc Penn State Health

Endometriosis is a highly prevalent disease and is accompanied by a variety of often severe symptoms. Despite this, it is poorly understood and difficult to manage. Surgical management for deep endometriosis (DE) is a mainstay in treatment, but due to limited evidence on techniques, current recommendations are based primarily on expert opinions of best practice. The European Society for Gynaecological Endoscopy (ESGE), the European Society of Human Reproduction and Embryology (ESHRE) and the World Endometriosis Society (WES) collaborated on summarizing these recommendations here. The authors define DE as endometrial-like tissue with a depth of > 5mm.  Several systems have been developed to classify the extent of DE. The ENZIAN classification is favored in the article, as it showed significant correlation between the extent of disease, difficulty and length of surgery and symptoms. The article stresses the importance of a detailed preoperative history and physical, appropriate imaging, and involvement of a multidisciplinary team if needed. For complex cases, and MRI can be a helpful and accurate tool for evaluation of the soft tissues in the pelvis.  The authors also suggest that patients with suspected ureteral DE have a renal ultrasound as part of their preoperative evaluation to rule out “silent hydronephrosis”.  The surgical approach differs based on location and extent of disease, but there is consensus that the approach should be primarily minimally invasive.  The authors discuss considerations for uterosacral ligament, rectovaginal septum with or without involvement of the rectum, urinary tract, and extra-pelvic endometriosis in detail. Recommendations for management of a frozen pelvis and the utility of a hysterectomy in women with severe DE are provided as well.  In summary, the article consolidates recommendations from an expert coalition into a single reference for the surgical management of DE the second guideline in what will likely be a series provided by the group.  The full article and recommendations can be accessed at the following link: http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7162667/ 

September 2020

Andrew W Horne, Katy Vincent, Catherine A Hewitt, Lee J Middleton, Magda Koscielniak, Wojciech Szubert, Ann M Doust, Jane P Daniels, on behalf of the GaPP2 collaborative Lancet, September 2020, Volume 396, page 909-917 Gabapentin for chronic pelvic pain in women (GaPP2): A multicentre, randomised, double-blind, placebo-controlled trial. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31693-7/fulltext

Article Review Summarized by Research Committee Chair, Georgine Lamvu, MD, MPH

Gabapentin has been shown effective in treating a variety of conditions ranging from chronic cough to chronic neuropathic pain.  The authors wanted to study whether gabapentin is a safe and effective treatment option for women with chronic pelvic pain (CPP) and no obvious pelvic pathology. This placebo-controlled trial was conducted across 39 medical centers in the UK. The trial included women who had pelvic pain of at least 3 months duration (including dysmenorrhea and dyspareunia) and negative laparoscopy.Participants were 18-50 years old and on contraception if pregnancy was a risk. The women were randomized to placebo or gabapentin (titrated up to 2700 mg daily) for a period of 16 weeks. The primary outcome was worst and average pain and outcomes were collected using weekly texts. Three hundred and six participants were randomized; 153 to placebo and 153 to gabapentin. There was no significant difference in baseline demographics or pain severity between the two groups at baseline. Adherence with the study protocol was high; 90% of the gabapentin and 93% of the placebo group completed the study. At the end of the study, there was no significant difference in both worst or average pain levels between the two groups: NRS pain mean score was 7·1 (+/- 2·6) in the gabapentin group and 7·4 (+/-2·2) in the placebo group, mean change from baseline was –1·4 (+/-2·3) in the gabapentin group and –1·2 (+/- 2·1) in the placebo group, mean average NRS pain score was 4·3 (+/-2·3) in the gabapentin group and  4·5 (+/- 2·2) in the placebo group, mean change from baseline was –1·1 (+/- 2·0) in the gabapentin group and –0·9 (+/- 1·8) in the placebo group. Additionally, more women had serious adverse events (7% vs 2%) and mild adverse events in the gabapentin group. 

This was a well-designed and conducted multi-center trial with few limitations, good generalizability and clinical impact. However, it is notable that besides negative laparoscopy, there was no description of whether other CPP conditions such as IC, IBS, Myalgia were excluded.  Based on the pathophysiology of these conditions, there is little evidence that they should respond to gabapentin. Perhaps it would have been more appropriate to limit the study to women with signs and symptoms of central sensitization or neuropathy (the authors acknowledge this limitation). Nonetheless, the trial shows that using gabapentin in all women with CPP is not recommended.

August 2020

Christopher Ecclestona,b,*, Fiona M. Blythc , Blake F. Deard , Emma A. Fishera,b, Francis J. Keefee , Mary E. Lynchf , Tonya M. Palermog,h, M. Carrington Reidi , Amanda C de C Williams (2020). Managing patients with chronic pain during the COVID-19 outbreak: considerations for the rapid introduction of remotely supported (eHealth) pain management services. PAIN, 161 (5), 889-893. http://dx.doi.org/10.1097/j.pain.0000000000001885

Article Review Summarized by Research Committee Chair, Georgine Lamvu, MD, MPH

Pain management providers are now rapidly converting face-to-face services to virtual and online telemedicine to accommodate patients with chronic pain conditions. Little research is available on the impact of these modes of healthcare delivery on patient pain, quality of life and access to care.  In this article, the authors discuss four factors to help guide providers in delivery of telehealth: 1) public health consequences, 2) consequences of not treating these patients for the duration of the pandemic, 3) options for remote management and 4) the clinical evidence supporting remote therapies.

July 2020

Commentary by Dr. Georgine Lamvu*

*The commentary is the opinion of the author as an individual and not intended to represent the position of other IPPS members.

Shanthanna, H., Strand, N. H., Provenzano, D. A., Lobo, C. A., Eldabe, S., Bhatia, A., Wegener, J., Curtis, K., Cohen, S. P., & Narouze, S. (2020). Caring for patients with pain during the COVID-19 pandemic: consensus recommendations from an international expert panel. Anaesthesia, 75 (7), 935–944. https://doi.org/10.1111/anae.15076

Chronic pain is a prevalent health problem that causes suffering and severely limits daily activity and quality of life. The COVID-19 pandemic led to cancellation or postponement of all elective procedures and limitation of outpatient visits including pain management services. Many patients with chronic pain also have additional co-morbidities that increase their risk for COVID-19 infection adding to the complexity of care. In this article, an expert panel of pain physicians, psychologists and researchers from North America and Europe provide some recommendations to guide care of chronic pain patients in these trying times. Although COVID-19 recommendations are still changing based on emerging data, the authors recommend postponing elective procedures (e.g. neurostimulators, intrathecal pumps). They also discuss opioid, naloxone, steroid and NSAID use. Generally, they recommend continued use of pharmacotherapy with additional patient education and collaboration with primary care and pharmacy. Telemedicine is strongly encouraged and psychological support, through telemedicine,  is also recommended. The full article and expanded recommendations are available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7262200/

June 2020

Commentary by Dr. Georgine Lamvu*

*The commentary is the opinion of the author as an individual and not intended to represent the position of other IPPS members.

1. Kelly M. Hoffman, Sophie Trawalter, Jordan R. Axt, and M. Norman Oliver. Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proceedings of the National Academy of Sciences, 2016;113 (16): 4296-4301; https://doi.org/10.1073/pnas.1516047113 

We cannot ignore the difficult times and racial turmoil that our nation is currently experiencing. As healthcare providers, we may want to remove ourselves from discussions about race, after all, we are trained to take care of anyone regardless of their racial or ethnic background. In fact, some of us serve underserved communities (Black, Latino, Native American), others have travelled to take care of communities ravaged by war and or poverty. The reality is that the work we do is not enough and we have a long way to go toward ensuring equal access and equal care for all.

Given the context of current events, I think it is important to take this time and reflect on how our own racial biases may affect the care we provide. I chose this article because it is an interesting look at how racial biases can be found even in the earliest stages of medical training (medical school and residency). Note that the authors are careful to state that these biases do not necessarily mean someone is racist, however, hidden biases may still affect how we provide pain care.

For the first time since we’ve been publishing ‘Research News’, we will not provide an interpretation of the article, instead I want the readers to use this information for self-reflection and reach their own conclusions. I would like to start that process by pointing out that in this study, nearly 40% of participants had a racial belief that is not substantiated by science. Read, and ask yourself: ‘What are my implicit biases?’, ‘How do my biases affect the care I provide to patients of different racial and ethnic backgrounds?’ 

May 2020

Article Summary by IPPS Research Committee Member

Two new publications DO NOT definitely support the use of Botulinum Toxin A in the treatment of pelvic myofascial pain.

1. Meister MR, et al. Effectiveness of Botulinum Toxin for Treatment of Symptomatic Pelvic Floor Myofascial Pain in Women: A Systematic Review and Meta-analysis. Female Pelvic Medicine & Reconstructive Surgery, 2020.
Available free access 

2. Levesque A, et al. Botulinum Toxin Infiltrations Versus Local Anesthetic Infiltrations in Pelvic Floor Myofascial Pain: Multicenter Randomized, double-blind study. Annals of Physical and Rehabilitation Medicine, 2020.
Available free access

Summary:  Botox has been extensively used for several years in the field of pelvic pain due to its action on pelvic muscle spasm. However, the efficacy of Botulinum injections has been controversial because of high cost and lack of high-quality efficacy studies. So far, in 2020, two new studies have been released on this subject.

The first meta-analysis (Meister et al) includes a combination of RCTs, prospective and retrospective observational studies. The authors concluded that a clinically and statistically significant reduction in pain (approximately 20-30 points on a 100m VAS scale) is noted in women who received Botulinum Toxin injections, and that this pain relief was sustained beyond 12 weeks after therapy. They also note smaller but significant improvements in dyspareunia, dyschezia and SF-12 scores, however, no improvements were noted in dysmenorrhea. The main limitation of this review is that it included studies with and without a comparison group and only two of the studies were randomized controlled trials. The authors also failed to mention, that the 2 randomized controlled trials that were included in the analysis, Dessie SG, 2019 and Bartley J, 2019 (data published only in clinicaltrials.gov), albeit they showed that patients improved after injections, they failed to demonstrate that Botulinum was superior to the comparator.

The second study (Levesque et al) was not included in the meta-analysis, likely because it was being published at the same time as the Meister study. However, this was an RCT that included 80 patients who received Botulinum injections vs. local anesthetic injections alone. Here the authors concluded that both groups demonstrated significant pain improvement after injections, however, Botulinum Toxin was not superior to local anesthetic.

Conclusion: the controversy on the efficacy of Botulinum Toxin will continue, however, despite the conclusions of the above meta-analysis, careful review shows that intramuscular injections using Botulinum Toxin are no more effective than injections using local anesthetic or other placebo. Clinicians should continue to perform intramuscular injections using compounds that are available and individualized to the circumstances of each patient. IPPS encourages future RCTs to better inform our treatment options.

April 2020

Article Summary by IPPS Research Committee Member - Dr. Ana Lucia Herrera Bentacourt (Colombia)

Botulinum Toxin Infiltrations Versus Local Anesthetic Infiltrations in Pelvic Floor Myofascial Pain: Multicenter, Randomized, Double-blind Study

Levesque, A., Ploteau, S., Michel, F., Siproudhis, L., Bautrant, E., Eggermont, J., Rabischong, B., Volteau, C., Perrouin-Verbe, M. A., & Labat, J. J.
Annals of physical and rehabilitation medicine, S1877-0657(20)30029-4.

Summary:  Botulinum toxin has been extensively used for several years in the field of pain, due to its action on muscle spasm. However, the efficacy of botulinum toxin in the context of chronic pelvic pain remains controversial. This multicenter, randomized, controlled, double-blind study was designed to compare the efficacy of botulinum toxin and local anesthetic (LA) injection versus LA injection alone for pelvic floor myofascial syndrome and chronic pelvic pain. According to the number of painful trigger points detected on physical examination, the patients received from 1 to 4 injections of botulinum toxin with LA (BTX) or LA alone. The primary endpoint was Patient Global Impression of Improvement (PGI-I) score on day 60 after infiltration. Secondary endpoints were pain intensity, number of painful trigger points on palpation, analgesic drug consumption and quality of life. The authors included 80 patients, 40 in each group. This study failed to demonstrate a significant difference between the 2 groups on day 60 in the primary endpoint or secondary endpoints (PGI-I score≤2=20% [LA] versus 27.5% [BTX], P=0.43). However, both groups showed significant alleviation of global pain. This study does not justify the use of botulinum toxin in the context of chronic pelvic pain with myofascial syndrome but does justify muscle injections with LA alone..

Full article available HERE.

March 2020

Article Summary by IPPS Research Committee Member

Incidence and Risk Factors for Pelvic Pain After Mesh Implant Surgery for the Treatment of Pelvic Floor Disorders

Elizabeth J. Geller,* Emma Babb, Andrea G. Nackley, and Denniz Zolnoun
J Minim Invasive Gynecol. 2017 Jan 1; 24(1): 67–73.

Summary:  The aim of this study was to assess incidence and risk factors for pelvic pain after pelvic mesh implantation. This was a retrospective study of women who have undergone surgery with pelvic mesh implant for treatment of pelvic floor disorders including prolapse and incontinence. Pain was measured by the McGill Short-Form Pain Questionnaire for somatic pain, Neuropathic Pain Symptom Inventory for neuropathic pain, Pennebaker Inventory of Limbic Languidness for somatization, and Female Sexual Function Index (FSFI) for sexual health and dyspareunia. General health was assessed with the 12-item Short-Form Health Survey. Among 160 enrolled women, mean time since surgery was 20.8 ± 10.5 months, mean age was 62.1 ± 11.2 years, 93.8% were white, 86.3% were postmenopausal, and 3.1% were tobacco users. Types of mesh included midurethral sling for stress incontinence (78.8%), abdominal/robotic sacrocolpopexy (35.7%), transvaginal for prolapse (6.3%), and perirectal for fecal incontinence (1.9%), with 23.8% concomitant mesh implants for both prolapse and incontinence. Our main outcome, self-reported pelvic pain at least 1 year after surgery, was 15.6%. Women reporting pain were younger, with fibromyalgia, worse physical health, higher somatization, and lower surgery satisfaction (all p < .05). Current pelvic pain correlated with early postoperative pelvic pain (p < .001), fibromyalgia (p = .002), worse physical health (p = .003), and somatization (p = .003). Sexual function was suboptimal (mean FSFI, 16.2 ± 12.1). Only 54.0% were sexually active, with 19.0% of those reporting dyspareunia. The authors concluded that 1 in 6 women reported de novo pelvic pain after pelvic mesh implant surgery, with decreased sexual function. Risk factors for denovo pain included younger age, fibromyalgia, early postoperative pain, poorer physical health, and somatization.

Full article available HERE.

February 2020

Article Summary by IPPS Research Committee Member

Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials.

Haller H, Lauche R, Sundberg T, Dobos G, Cramer H.
BMC Musculoskeletal Disorders, 2020; 21:1

Summary: The objective of this systematic review and meta-analysis was to assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. The authors identified 10 RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain. CST showed greater post intervention effects on: pain intensity (SMD = -0.32, 95%CI = [- 0.61,-0.02]) and disability (SMD = -0.58, 95%CI = [- 0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD = -0.63, 95%CI = [- 0.90,-0.37]) and disability (SMD = -0.54, 95%CI = [- 0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD = -0.53, 95%CI = [- 0.89,-0.16]) and disability (SMD = -0.58, 95%CI = [- 0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD = -0.59, 95%CI = [- 0.99,-0.19]) and disability (SMD = -0.53, 95%CI = [- 0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. The authors concluded that in patients with chronic pain, CST significantly improves pain and function lasting up to six months. . 

Full article available HERE.

January 2020

Article Summary by IPPS Research Committee Member

Pharmacological Interventions for Treating Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Franco JV1, Turk T, Jung JH, Xiao YT, Iakhno S, Tirapegui FI, Garrote V, Vietto V.
Cochrane Database Syst Rev. 2019

Summary: Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is characterized as pelvic pain and lower urinary tract symptoms. This systematic review aimed to assess the efficacy of pharmacological therapies for CP/CPPS, which is considered a complex and multifactorial disorder. In the review, the authors included randomized controlled trials conducted in men a diagnosis of CP/CPPS. They evaluated all available pharmacological interventions compared to placebo or in head-to-head comparisons. The authors identified 99 unique studies assessing 16 types of pharmacological therapies. Overall, they found low- to very low-quality evidence that alpha blockers, antibiotics, 5-ARI, anti-inflammatories, phytotherapy, intraprostatic BTA injection, and traditional Chinese medicine may cause a reduction in prostatitis symptoms without an increased incidence of adverse events in the short term, except for alpha blockers which may be associated with an increase in mild adverse events. There were few trials with active comparators and little evidence of the effects of these drugs on sexual dysfunction, quality of life or anxiety and depression. 

Full article available HERE.

Archived Research News

2019 Research News