"Alexa, I’m in pain! "A Real-Time Mindfulness Intervention to Control Pain: Delivery Through a Conversational Agent
We are interested in learning about people’s experiences with using the Amazon Alexa for delivery of a real-time mindfulness intervention to help with chronic pain management. Participation will include a free day-long introductory mindfulness training followed by daily use of mindfulness practices using the Amazon Alexa to establish a habit of use.
The participants will use our developed Amazon Alexa app ("skill") and provide assessments. We will ask participants to complete short daily surveys and a follow-up interview.
Sebrina Doyle at sld40@psu.edu
All
18 year(s) or older
N/A
Pain Management
SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain
Endometriosis is a common chronic condition that can cause pain in the lower part of the stomach (pelvis) during the menstrual period and at other times and pain during sexual intercourse.
The purpose of this study is to test how effective and safe the investigational study drug, relugolix (rel-U-GO-lix), given with or without low-dose estradiol and norethindrone is in treating endometriosis-associated pain. Estradiol is a form of estrogen and norethindrone is form of progesterone. Both estrogen and progesterone are hormones normally made by women’s bodies. These hormones help control the menstrual cycle and menstrual periods and also support bone health. The study wants to know if endometriosis pain affects how women function, how they feel and if the study drug is effective and safe at treating the pain from endometriosis.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
NCT03204318
Pain Management, Women's Health
A Phase 3 multicenter, randomized, double-blind, placebo-controlled, clinical study to assess the efficacy and safety of linzagolix in subjects with moderate to severe endometriosis-associated pain.
The purpose of this study is to look at the safety and efficacy of different doses of linzagolix alone and together with so-called ‘add-back therapy’ (hormones) compared to placebo (an inactive sugar pill) in women with moderate to severe pain associated with endometriosis.
Endometriosis is when tissue that normally grows inside the uterus grows outside the uterus. It is one of the most common gynecological diseases. The condition is mainly found in women in their reproductive years and disappears spontaneously after menopause. Symptoms can include painful periods, chronic pelvic pain, pain with bowel movement, pain during intercourse and urination problems.
Linzagolix is an experimental drug which is not approved for the treatment of moderate to severe pain associated with endometriosis. Linzagolix has been shown to significantly reduce pain associated with endometriosis in women with endometriosis at once daily doses between 50 and 200 mg with a good safety and tolerability profile.
About 450 women will take part in this study at a number of different locations in the US and Canada. This study will have up to 16 study visits over a period of approximately 15 months.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
NCT03986944
Pain Management, Women's Health
Site for A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation versus Cognitive Behavioral Therapy for Opioi-Treated Chronic Low Back Pain
This study will use mindfulness meditation (MM) or cognitive behavioral therapy (CBT) on patients with chronic low back pain to help improve their health outcomes and reduce opioid dependence. Subjects will be randomized to the MM or CBT group and asked to complete at home or group activities while also completing surveys.
Amanda Taylor Gehman at ataylor6@pennstatehealth.psu.edu or 717-531-1283
All
18 year(s) or older
NCT03115359
Pain Management
A volunteer study to determine the anatomical distribution of injectate, the extent of sensory block, and the pharmacokinetics of ropivacaine following Erector Spinae Plane (ESP) blocks.
This study will recruit healthy volunteers to determine the effect of a peripheral nerve block. The participants will get an injection in their back muscle after an intravenous line is placed in their hand or arm. After the injection they will have two MRI done at 30 and 90 minute time intervals. A half tablespoon of blood also will be taken through the IV line already placed 6 times during the study period starting just before to Peripheral nerve block placement up to four hours post injections. They will be discharged from the study after half an hour of the last blood sample. During this whole process they will be monitored for their blood pressure, oxygen saturation and other effects related to the procedure.
Astoria Huller at ahuller@pennstatehealth.psu.edu or 717-531-0003, ext=282465
All
18 year(s) or older
NCT03476642
Prevention, Muscle & Bone, Pain Management
A randomized double-blind placebo controlled trial to assess the effectiveness of low-dose naltrexone in combination with standard treatment in women with chronic pelvic pain secondary to endometriosis.
Pelvic pain associated with endometriosis is in part due to inflammation of a layer of tissue in the abdomen (stomach area). This leads to the great potential of relieving endometriosis related pelvic pain in a non-narcotic medication by decreasing the inflammation. The purpose of this study is to evaluate how a low dose of naltrexone compared to placebo (inactive substance) impacts your daily pain and the quality of your life with endometriosis. Naltrexone is approved by the U.S. Food and Drug Adminstration (FDA) for the treatment of opioid overdose and addiction. At much lower doses, naltrexone has been shown to be beneficial in pain relief of inflammatory disorders with promising results, but the use of the low dose in this study to treat endometriosis pain is investigational and has not been approved by the FDA.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
NCT03970330
Pain Management, Women's Health