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26 Foot Pain Trials Near You
Power is an online platform that helps thousands of Foot 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 PowerFoot Rehab + Minimalist Shoes for Plantar Fasciitis
Charlottesville, Virginia
The goal of this clinical trial is to compare the effects of 8 weeks of foot rehabilitation exercises in conjunction with wearing minimalist shoes in individuals with plantar fasciopathy, compared to only performing foot rehabilitation exercises. The main questions it aims to answer are:
* Will individuals with plantar fasciopathy be able to reduce their pain and improve their self-reported function by performing rehabilitation exercises and wearing minimalist shoes, compared to those only performing rehabilitation exercises?
* Will individuals with plantar fasciopathy be able to increase their intrinsic foot muscle strength and size, their balance, and gait biomechanics by performing rehabilitation exercises and wearing minimalist shoes, compared to those only performing rehabilitation exercises?
* What characteristics of individuals with plantar fasciopathy make them most suited to succeed in a protocol of performing rehabilitation exercises and wearing minimalist shoes?
Participants will be asked to come into the lab at the start of the intervention and after 8 weeks, where the following will be assessed:
* Patient-reported outcomes
* Foot morphology
* Intrinsic foot muscle strength
* Balance
* Gait biomechanics
For the intervention, participants in both groups will perform the same rehabilitation exercises, including:
* Massage to the bottom of the foot
* Calf-raises
* Calf and foot stretches
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Other Injuries, Foot/ankle Surgeries, Others
34 Participants Needed
Lipiodol Injection for Plantar Fasciitis
Falls Church, Virginia
This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar fasciitis. Participants will undergo a minimally invasive procedure called plantar fascia embolization (PFE) to reduce inflammation and pain in the affected area. The study aims to assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22 - 100
Key Eligibility Criteria
Disqualifiers:Arthritis, Gout, Bursitis, Diabetes, Others
Must Not Be Taking:Corticosteroids
10 Participants Needed
Nutrition and Exercise Instruction for Weight Changes
Hershey, Pennsylvania
The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Vertigo, Balance Issues, Others
50 Participants Needed
Medrol Dosepak for Foot and Ankle Surgery
Johns Creek, Georgia
This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries.
The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe Heart Disease, Renal Failure, Liver Dysfunction, Diabetes, Others
180 Participants Needed
Liposomal Bupivacaine + Dexamethasone for Foot Surgery
Philadelphia, Pennsylvania
This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Revision Cases, Allergies, Abuse History, Others
Must Not Be Taking:Opioids
126 Participants Needed
Orthoses for Plantar Fasciitis
Saguenay, Quebec
Foot pain is common in the general population. Plantar fasciopathy may affect 7% of the population at some time in their lives, but the incidence increases with age. This plantar problem is characterized by severe pain under the foot (at plantar level), which can be very incapacitating and disabling. This can lead to absenteeism from work, particularly for employees working in a standing posture. Various therapeutic avenues can be used to reduce pain and improve functionality, such as physiotherapy, infiltrations and surgery. In this research project, the propose the use of a conservative approach through the use of foot orthoses, which appears to be effective in reducing pain. The aim of the study is thus to better understand the effect of foot orthoses on postural balance and walking in workers with plantar fasciopathy. Participants will be assessed at baseline and eight weeks later to observe measured changes and clinical improvements following orthotic wear. Balance and gait pattern will be assessed using technological tools that have been validated in this respect. Participants will also be asked about their pain intensity. The hypothesis is that wearing the orthosis will improve the participants' balance and walking abilities, as well as reduce the level or intensity of their pain. In addition, this study could have an impact on the rate of absenteeism from work from current context of labour shortages.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:20 - 65
Key Eligibility Criteria
Disqualifiers:Severe Systemic Diseases, Tumors, Others
40 Participants Needed
This trial is testing whether using electrical acupuncture on the ear can help reduce the need for strong painkillers for patients having surgery for lower leg fractures with spinal anesthesia. The idea is that this method might help manage pain better, so fewer opioids are needed. Electroacupuncture has been shown to reduce pain and the need for pain relief in various surgical settings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Renal Dysfunction, Allergy, Communication Issues, Others
140 Participants Needed
Therapeutic Shoes for Plantar Fasciitis
Harlingen, Texas
The research project aims to evaluate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 70
Key Eligibility Criteria
Disqualifiers:Plantar Ulcer, Major Foot Deformities, Amputation, Others
Must Not Be Taking:Oral Anti-inflammatories
50 Participants Needed
Peer Support for Diabetic Foot Ulcers
Pomona, California
The objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
24 Participants Needed
Cryoneurolysis for Diabetic Neuropathy
La Jolla, California
The study is a single-center, randomized, participant- and observer-masked, human-subjects, post-market clinical pilot study to investigate the use of ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 6 minutes for each nerve, involves little discomfort, has no systemic side effects, and cannot be misused or become addictive. Participants will be randomly allocated to one of two possible treatments groups: cryoneurolysis (experimental) or sham (control). The primary outcome measure is the change in pain on the neuropathic pain scale from baseline 1 month following the procedure.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Reynaud Syndrome, Cryoglobulinemia, Cold Urticaria, Others
30 Participants Needed
Shoe Insoles for Knee Osteoarthritis
Vancouver, British Columbia
Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Lateral OA, Knee Surgery, Systemic Arthritis, Others
Must Not Be Taking:Corticosteroids
36 Participants Needed
Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness
Mississauga, Ontario
The research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:8+
Key Eligibility Criteria
Disqualifiers:Wound Management, Insensate Feet, Ulcerations, First-time AFO Users
50 Participants Needed
Standardized Anesthesia Protocol for Le Fort Fracture Surgery
Baltimore, Maryland
This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hope this will help to minimize unnecessary postoperative pain management, inpatient stay, and long-term morbidity and mortality in these patients.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 18
Key Eligibility Criteria
Disqualifiers:Contraindications To Anesthetic Protocol
50 Participants Needed
Chronic Disease Prevention Program for Chronic Disease
Chapel Hill, North Carolina
The proposed study, NC Works4Health (NCW4H), builds on the strengths of long-standing academic-community research partnerships between this UNC at Chapel Hill (UNC) team of investigators and key stakeholders across health, social service, employment, and economic development sectors. The overall goal of this study is to test the effectiveness of a multilevel intervention that can be readily adopted by communities to reduce chronic disease risks in socioeconomically disadvantaged populations by (a) embedding prevention efforts in DSS-E programs at the individual level, and (b) enhancing supervisor supports for DSS-E hires at the employer level. Interventions at each level, and their joint effects, are designed to mitigate the psychological, behavioral, and clinically relevant risks for chronic disease onset, morbidity, and comorbidity that accrue with unemployment and the employment-entry transition.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Disability Benefits, Pregnancy, Severe Hypertension, Cancer, Inflammatory Bowel Disease, Others
600 Participants Needed
Salbutamol Inhaler for Allergic Abdominal Pain
Montréal, Quebec
The goal of this study is to assess the efficacy of inhaled salbutamol to treat abdominal pain during food allergic reactions.
Patients experiencing abominal pain as a result of a food allergic reaction during a food challenge in the allergy clinic will be invited to participate to the study.
They will receive either 8 puffs of salbutamol (asthma inhaler) or 8 puffs of a placebo inhaler.
The abdominal pain will then be followed using a numeric scale to see if patients receiving the medication experienced a faster improvement compared to those receiving the placebo.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 55
Key Eligibility Criteria
Disqualifiers:Adverse Reaction To Salbutamol, Hypersensitivity, Hyperglycemia, Arrhythmia, Others
Must Not Be Taking:Beta-blockers, Long-acting Beta Agonists
498 Participants Needed
Lidocaine vs Bupivacaine for Postoperative Pain
Boston, Massachusetts
In this research study, we want to learn more about the impact of two different local anesthetics (bupivacaine and lidocaine) on patient experience following orthognathic (jaw) surgery. Both anesthetics are within the standard of care for dental and orthognathic procedures, but can vary in how quickly they take action and how long they last. This study will provide us with a greater understanding of how anesthetic choice affect patient outcomes, and how we can strive to make these outcomes as favorable as possible.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:15 - 35
Key Eligibility Criteria
Disqualifiers:Chronic Pain, Allergic Reactions, Pregnancy, Others
100 Participants Needed
Spinal Cord Stimulation for Phantom Limb Pain
Pittsburgh, Pennsylvania
The goal of this project is to characterize the types of sensations that can be evoked via electrical stimulation of the spinal cord and spinal nerves. Patients will be recruited from a local pain clinic, each with a spinal cord stimulation device implanted, to participate in experiments to explore the ability to modulate and control the modality, intensity, focality, and location of the sensations evoked by stimulation through the spinal cord stimulator leads. Investigators will connect spinal cord stimulator leads to a custom stimulator system and will ask subjects to report the types of sensations felt. Invesigators will also perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Open Wounds, Metal Rods, Defibrillator, Others
30 Participants Needed
DRG Stimulation for Complex Regional Pain Syndrome
Chicago, Illinois
This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area.
Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation). Group 2 will have their frequency set at 5 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation) This study will be performed in a crossover fashion, meaning patients will be changed to the alternate dosing regimen at the 13-week time period.
Patients will be seen and evaluated prior to randomization and reprogramming, and thereafter evaluated at 4, 8, and 12-weeks. At the 12-week time period, patients will begin a 1-week washout period of continuous stimulation. At the 13-week time period, patients will be evaluated, crossed over to the other study arm and thereafter evaluated at 17, 21, and 25-weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Lead Migration, Other Neuromodulation, Others
Must Not Be Taking:Corticosteroids
30 Participants Needed
Food Assistance Interventions for Cancer Patients
New York, New York
The investigators have found that many patients getting treatment for cancer have trouble getting enough to eat, or do not always have enough money for food. When a patient has these problems it can lead to difficulties with completing cancer treatment. Across New York City, there are many hospitals that offer their patients food pantry services on location. The investigators would like to compare how food pantries within the hospital and two other food assistance options: monthly food vouchers and weekly grocery deliveries maybe possible solutions to this problem. The patient will be randomly assigned to one of the three different food program groups, which means everyone has an equal chance in being in any group, like a flip of a coin. The investigators hope to learn how to best help patients with trouble getting food and to see if this will help with completing cancer treatment.
The original RCT composed of study arms: 1) hospital -based food pantry (control), 2) food voucher program plus access to the food pantry, and 3) grocery delivery program plus access to the food pantry will remain open to accrual at Ralph Lauren Cancer Center. The other three sites of the original RCT, Lincoln Hospital, Queens Cancer Center and Brooklyn Hospital, have reached target accrual. Our modified RCT, to be carried out among an expanded cohort of cancer patients is composed of study arms : 1) Food Voucher Program (Voucher); 2) Home Grocery Delivery Program (Delivery); and 3) Medically-tailored, Hospital-based Food Pantry (Pantry).
For this RCT, we will enroll patients across Bronx hospitals- Jacobi Medical Center, St. Barnabas Hospital, and Montefiore Medical Center. For the new study arms, we will enroll patients across Lincoln Medical and Mental Health Center, Jacobi Medical Center, St. Barnabas Medical Center, Montefiore Health System, New York Cancer \& Blood Before Specialists, and Bellevue Hospital. Before conducting the RCT across Lincoln Medical and Mental Health Center and the new sites in the Bronx, we will refine written educational materials to be used in the intervention through focus groups.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Psychiatric Disturbance, Cognitive Impairment, SNAP, Others
668 Participants Needed
Bupivacaine for Pain Management
New York, New York
The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, High Blood Pressure, Tobacco, Others
Must Not Be Taking:Opioids, Marijuana
150 Participants Needed
Why Other Patients Applied
"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
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"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've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
Dorsal Root Ganglion Stimulation for Knee Arthritis
New York, New York
Dorsal root ganglion stimulation (DRG-S) may be able to treat mechanical pain caused by tissue injury or damage such as trauma or arthritis in addition to pain caused by nerve dysfunction or injury. The purpose of this study is to determine if dorsal root ganglion stimulation (DRG-S) can effectively treat arthritic pain of the knee.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21+
Key Eligibility Criteria
Disqualifiers:Non-English, Pregnancy, BMI >45, Others
Must Not Be Taking:Opioids
30 Participants Needed
Flavored, Carbonated Drinks for Dry Mouth
Valhalla, New York
To determine the effect of flavored, carbonated drinks on salivary flow rate, saliva composition, and taste perceptions compared with control drinks (water, carbonated water, non-carbonated)
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Nicotine Use, Recent Illness, Oral Conditions, Dysgeusia, Parosmia, Cardiovascular, Others
13 Participants Needed
Deep Brain Stimulation for Chronic Pain
San Francisco, California
This trial tests a new type of brain stimulation device for people with chronic pain that doesn't respond to other treatments. The device sends electrical signals to different parts of the brain and adjusts these signals based on real-time pain levels. The goal is to provide better and longer-lasting pain relief.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22 - 80
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Severe Diabetes, Active Depression, Others
12 Participants Needed
TMS for Neuropathic Pain
San Francisco, California
Chronic neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. It is highly prevalent, debilitating, and challenging to treat. Current available treatments have low efficacy, high side effect burden, and are prone to misuse and dependence. Emerging evidence suggests that the transition from acute to chronic neuropathic pain is associated with reorganization of central brain circuits involved in pain processing. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment that uses focused magnetic pulses to non-invasively modulate brain activity, a strategy that can potentially circumvent the adverse effects of available treatments for pain. RTMS is FDA-approved for the treatment of major depressive disorder, obsessive-compulsive disorder, and migraine, and has been shown to reduce pain scores when applied to the contralateral motor cortex (M1). However, available studies of rTMS for chronic neuropathic pain typically show variable and often short-lived benefits, and many aspects of optimal treatment remain unknown, including ideal rTMS stimulation parameters, duration of treatment, and relationship to the underlying pain etiology. Here the investigators propose to evaluate the efficacy of high frequency rTMS to M1, the region with most evidence of benefit in chronic neuropathic pain, and to use functional magnetic resonance imaging (fMRI) to identify alternative rTMS targets for participants that do not respond to stimulation at M1. The central aim is to evaluate the pain relieving efficacy of multi-session high-frequency M1 TMS for pain. In secondary exploratory analyses, the investigator propose to investigate patient characteristic that are predictive of responsive to M1 rTMS and identify viable alternative stimulation targets in non-responders to M1 rTMS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Dementia, Seizure Disorder, Cardiac Disease, Others
Must Be Taking:Chronic Pain Medications
32 Participants Needed
Prophylactic Foraminotomy for C5 Palsy
Cleveland, Ohio
C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of life. Furthermore, about half of patients with C5P present with sensory deficits and/or intractable pain in addition to the muscle weakness.
Prophylactic bilateral foraminotomy at the C5 level during cervical decompression surgery has been studied recently with the hope that it will minimize the risk of developing a C5 nerve root palsy postoperatively. Although the current literature provides some support for this claim, there are insufficient data establishing this technique as a proven measure to reduce the incidence of C5P. In the present study, we seek to evaluate the effect of bilateral foraminotomy on postoperative C5P incidence rates.
Bilateral foraminotomy has been correlated with a reduced risk of developing C5P following cervical decompression surgery, but an identical foraminotomy procedure has never been applied in a randomized manner to all qualifying patients in a study. Additionally, prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the proposed study, bilateral foraminotomy will be randomized to patients receiving cervical decompression surgery (laminoplasty, laminectomy, fusion). This is a multicenter randomized trial, including the following sites: Cleveland Clinic, Columbia University Medical Center, and University of Southern California Spine Center. Patients undergoing cervical decompression surgery will be consented and enrolled if they meet the inclusion and exclusion criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of prophylactic C5 bilateral foraminotomy during cervical decompression.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, C5 Radiculopathy, Prior Surgery, Others
480 Participants Needed
Extended Care Interventions for Weight Loss Maintenance
Birmingham, Alabama
The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people.
* The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance.
* The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people.
Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off.
The four components participants could be assigned to in Phase 2 are:
1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly
2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home
3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant
4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way
Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hypertension, Diabetes, Others
Must Not Be Taking:Weight Loss Medications
544 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do Foot 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 Foot 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 Foot 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 Foot 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 Foot 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 Foot Pain clinical trials?
Most recently, we added Spinal Cord Stimulation for Phantom Limb Pain, Extended Care Interventions for Weight Loss Maintenance and Standardized Anesthesia Protocol for Le Fort Fracture Surgery to the Power online platform.
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