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46 Pelvic Pain Trials Near You
Power is an online platform that helps thousands of Pelvic Pain patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerShockwave Therapy for Erectile Dysfunction
Cleveland, Ohio
The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Cardiac Disease, Others
Must Not Be Taking:SSRI, Psychotropic
186 Participants Needed
Online Education for Chronic Pelvic Pain
Ann Arbor, Michigan
This research is studying what things change the way people think about treatment for chronic pelvic pain (CPP). The study team is also interested in whether a web-based educational and self-management program for chronic pelvic pain changes how people think about chronic pelvic pain treatments. The program contains several different self-guided modules that include cognitive and behavioral structuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques.
The study hypothesis is that patients with CPP will report that prior treatment experiences and most trusted source of medical information will be associated with baseline perceptions of various CPP treatment modalities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Severe Physical Impairment, Others
30 Participants Needed
Online Self-Management Program for Chronic Pelvic Pain
Ann Arbor, Michigan
The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).
The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Recent Surgery, Pregnancy, Severe Impairment, Psychosis, Others
125 Participants Needed
Cognitive Behavioral Therapy for Chronic Pelvic Pain Syndrome
Ann Arbor, Michigan
This trial tests a brief cognitive behavioral therapy to help people with chronic pelvic pain. It aims to teach skills for managing pain and symptoms with minimal clinician help. The study focuses on adults with conditions like interstitial cystitis and chronic prostatitis, which are hard to treat with current methods. The therapy works by changing how patients think about and cope with their pain. Cognitive Behavioral Therapy (CBT) has been shown to be an effective treatment for chronic pain in numerous studies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Urethral Stricture, Pelvic Malignancy, Major Psychiatric Disorder, Others
240 Participants Needed
Multimodal Bundled Care for Chronic Pelvic Pain
Pittsburgh, Pennsylvania
The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. The participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. This study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Active Infection, Language Barrier, Recent Procedure, Others
26 Participants Needed
Pelvic Health Therapy for Pelvic Radiotherapy Patients
Carmel, Indiana
The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Major Illnesses, Psychiatric Impairments, Prior Pelvic Radiation, Others
20 Participants Needed
Sacral Neuromodulation for Chronic Pelvic Pain
Royal Oak, Michigan
Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device implant procedure.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22 - 70
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pelvic Cancer, Severe Diabetes, Interstitial Cystitis, Others
25 Participants Needed
Baclofen Suppositories for Chronic Pelvic Pain
Louisville, Kentucky
The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms of Chronic Pelvic Pain (CPP).
Participants in this study will take four short questionnaires prior to being randomized. Randomization is like flipping a coin; participants have an equal likelihood of being randomized to the treatment group (vaginal baclofen suppositories) or placebo group (vaginal suppository without baclofen ingredient). Participants will take their assigned treatment nightly for 8 weeks. Follow up visits will be at the 4 and 8 week time frames, when questionnaires will again be completed. Participants may receive additional treatments for CPP during the course of the study. After 8 weeks Participants will be offered a prescription for baclofen suppositories and the study drug will be stopped. Follow up on patient symptoms with questionnaires will again occur at 12 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Cancer, Others
44 Participants Needed
Bupivacaine Injection for Pudendal Neuralgia
Louisville, Kentucky
Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. This pain syndrome is difficult to diagnose and patients with pudendal neuralgia may present to providers with refractory chronic pelvic pain. Pudendal nerve infiltration or pudendal nerve block (PNB) serves as a diagnostic tool and treatment modality for patients with this condition. To date, there are no published randomized controlled trials comparing imaging-guided PNB to transvaginal finger-guided PNB. While one can assume that image-guided nerve blocks will provide better accuracy for injection and potentially better efficacy in pain relief as a result, no published data exists comparing the outcomes and efficacy between modalities.
The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger-guided pudendal nerve block versus bilateral fluoroscopy-guided trans gluteal pudendal nerve block for patients with pudendal neuralgia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Pelvic Surgery, Neurologic Disease, Others
40 Participants Needed
CBT vs. Empowered Relief for Chronic Pain
Louisville, Kentucky
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Active Suicidality, Others
1650 Participants Needed
Myfembree for Fibroids
Schererville, Indiana
This trial is testing Myfembree, a pill that combines three medications, to help women who have had surgery for fibroids. The goal is to delay the return of fibroid symptoms and improve their quality of life. Myfembree works by lowering certain hormone levels and balancing others to reduce heavy menstrual bleeding and other symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Osteoporosis, Liver Disease, Cardiovascular, Others
Must Be Taking:Myfembree
136 Participants Needed
Hyivy Device for Pelvic Cancer
Kitchener, Ontario
Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study is designed as a proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Major Surgery, Infections, Others
Must Not Be Taking:Antibiotics
12 Participants Needed
Vein Embolization for Chronic Pelvic Pain
Chicago, Illinois
The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins.
The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Post-menopausal, Others
40 Participants Needed
Relugolix-Combination Therapy for Pelvic Pain
Evanston, Illinois
The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 35
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Migraines, Osteoporosis, Smoking, Others
60 Participants Needed
NSAIDs for Menstrual Cramps
Evanston, Illinois
The goal of this clinical trial is to learn if NSAIDs (i.e. naproxen sodium) can treat menstrual pain and prevent the development of chronic pelvic pain in menstruating adults with painful periods. The main questions it aims to answer are:
* Can non-menstrual pelvic pain reduction be predicted by menstrual pain response to NSAIDs?
* Will participants with the largest reductions in multi-site sensitivity following NSAID therapy have the largest reductions in non-menstrual pelvic pain?
Researchers will compare naproxen sodium to a placebo (a look-alike substance that contains no drug) to see if naproxen sodium works to treat painful periods.
Participants will:
* Take naproxen sodium or placebo during several days of their menstrual period every month for 1 year.
* Complete computer questionnaires and tests from home every 3 months.
* Complete at-home urine tests to measure hormones every few days for 1-year.
* Use a pin-prick to collect a small spot of blood, and use a pad or tampon to collect a sample of menstrual blood, and bring it to the research site twice over a 1-year period.
* Come to the research site twice over a 1-year period to complete sensory assessments and undergo a blood draw.
The major goal of the study is to develop a multivariable statistical model (see https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-021.html ) describing the factors that effectiveness of pain medication and risk for chronic pain
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 35
Sex:Female
Key Eligibility Criteria
Disqualifiers:Chronic Pain, GI Bleeding, Others
Must Be Taking:NSAIDs
600 Participants Needed
Hyivy Device for Endometriosis
Hamilton, Ontario
This trial is testing the Hyivy device, which is designed to help reduce pelvic pain. The study focuses on people with endometriosis, a condition that causes significant pelvic pain. The device likely uses physical therapy methods to ease this pain.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Vaginal Infections, Surgery, Others
Must Be Taking:Hormonal Medications
20 Participants Needed
Cryotherapy for Pregnancy-Related Pelvic Girdle Pain
Maywood, Illinois
The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
88 Participants Needed
PEMF Therapy for Interstitial Cystitis
Winston-Salem, North Carolina
The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and/or associated symptoms of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) patients. The study team will distribute the PEMF device to female adults with IC/BPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Cancer, Stroke, MS, Others
Must Be Taking:Bladder Instillations
20 Participants Needed
Vibrating Pelvic Floor Device for Painful Intercourse
Washington, District of Columbia
The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators.
The main questions it aims to answer are:
1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators
2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators?
Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief.
Participants will:
* Be randomly assigned to use either the Kiwi device or traditional vaginal dilators.
* Use the assigned device three times per week for 15 minutes per session over four weeks.
* Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pelvic Radiation, Genital Malignancy, Others
60 Participants Needed
CBD for Endometriosis Pain
Hershey, Pennsylvania
This trial is testing CBD to see if it can help reduce pain and improve the quality of life for patients with endometriosis. The study will compare different doses of CBD over a few months. Researchers believe CBD may work by affecting the body's natural systems that control pain and inflammation. CBD has been shown to significantly improve pain intensity in some studies, although evidence quality is low due to high risk of bias and small sample sizes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
36 Participants Needed
Why Other Patients Applied
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
TENS for Endometriosis Pain
Hershey, Pennsylvania
The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiac Arrhythmia, Others
40 Participants Needed
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Psychotic Disorders, Cancer, Others
220 Participants Needed
Peer Empowered Endometriosis Pain Support for Endometriosis
Saint Louis, Missouri
The goal of this clinical trial is to determine if Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week interdisciplinary, integrative group care program, decreases pain interference in participants with endometriosis-associated chronic pelvic pain between the ages 18 and 48. The main question we aim to answer is:
Is PEEPS more effective than Education in decreasing pain interference?
Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain, physical function, and quality of life.
Participants will:
* Complete baseline quality of life surveys
* Participate in an 8-session group care program
* Provide feedback on each session and the program globally
* Complete follow up quality of life surveys at PEEPS completion, 6- and 12-months post-completion.
* A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 48
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Impairment, Psychosis, Others
Must Not Be Taking:Opioids
60 Participants Needed
Group Care Program for Endometriosis
Saint Louis, Missouri
The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain. The main question\[s\] it aims to answer are:
* Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes?
* What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 48
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Physical Impairment, Psychiatric Disorder, Others
Must Not Be Taking:Opioids
33 Participants Needed
Pelvic Exam Tool for Gynecologic Cancer Survivors
Saint Louis, Missouri
The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pelvic Radiation, Interstitial Cystitis, Others
Must Be Taking:Radiosensitizing Platinum
22 Participants Needed
Preoperative Gabapentin for Pelvic Organ Prolapse
Iowa City, Iowa
This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.
Trial Details
Trial Status:Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
110 Participants Needed
Muscle Energy Techniques for Pelvic Pain
Harlem, New York
The goal of this clinical trial is to compare the efficacy of pelvic muscle energy technique online against the traditional full length osteopathic pelvic treatment protocol. The main question it aims to answer are
• Can one single pelvic muscle energy technique can correct all pelvic somatic dysfunctions (SD)?
Participants will
* be positioned by the physician into the area of treatment into a position of resistance, which is the restrictive barrier.
* be instructed to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce.
* be instructed to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier.
* These steps are repeated three to five times and then the dysfunction is reevaluated.
Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one and be compared with the pelvic muscle energy group.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Acute Pelvic Pain, Pregnancy, Pelvic Trauma, Others
100 Participants Needed
Photobiomodulation for Chronic Pelvic Pain
Birmingham, Alabama
The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain in women. Additionally, researchers want to determine if treatment with this type of energy can also alleviate pain with activities such as standing, sitting, urinating, having bowel movements and intercourse.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Sex:Female
Key Eligibility Criteria
Disqualifiers:Cancer History, Autoimmune Conditions, Vaginal Trauma, Others
Must Not Be Taking:Heat-sensitive, Light-sensitive
126 Participants Needed
QL Block + ERAS Protocol for Postoperative Pain
Birmingham, Alabama
In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-English Fluency
70 Participants Needed
Photobiomodulation + Physiotherapy for Vulvodynia
Ottawa, Ontario
This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and sexual health of an astounding one in five Canadian women, yet access to evidence-informed management approaches is limited. We will employ four intervention groups: PBM, sham PBM (control), PBM combined with mPT, and mPT with sham PBM to evaluate the effectiveness of each approach on its own and the two approaches in combination.
Among those who experience PVD, we seek to answer:
1. Relative to baseline and to sham PBM, does a 14-week intervention involving PBM, mPT, or a combination of mPT and PMB reduce vulvar pain severity reported on the Vulvar Pain Assessment Questionnaire (VPAQ)?
2. Is a combined mPT and PBM intervention more effective than mPT or PMB alone when considering vulvar pain severity and/or related domains as measured through VPAQ?
3. Are positive changes in vulvar pain severity and related domains observed following a 14-week intervention involving PBM, mPT or a combination of PBM and mPT retained at 6 months and at 1 year?
Secondary objectives include determining the effectiveness of PBM, mPT, and mPT combined with PBM relative to sham PBM on: Patient Global Impression of Change (PGIC), pain sensitivity measured using provocative tests, the other domains of the VPAQ, sexual function, as well as investigating mediating effects of psychosocial variables (central sensitization index, chronic pain acceptance), gender identity, and the presence of vaginismus on patient response to mPT, PBM and mPT combined with PBM. Lastly we will monitor patient satisfaction with the interventions, adherence to the interventions, and any adverse events.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Lichen Sclerosus, Endometriosis, Others
240 Participants Needed
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Frequently Asked Questions
How much do Pelvic Pain clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Pelvic Pain clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Pelvic Pain trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Pelvic Pain is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Pelvic Pain medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Pelvic Pain clinical trials?
Most recently, we added PEMF Therapy for Interstitial Cystitis, Hyivy Device for Endometriosis and Sacral Neuromodulation for Chronic Pelvic Pain to the Power online platform.
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