Treatment Trials

23 Clinical Trials for Various Conditions

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RECRUITING
Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
Description

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.

COMPLETED
Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
Description

Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no other injury that limits their ability to run and jump. Parents of subjects will be invited to participate by completing questionnaires related to their perspective of their child's symptoms, physical activity level, quality of life, and their satisfaction with the treatment protocol. Subjects will be asked to attend 4 monthly sessions consisting of evaluation and treatment.

COMPLETED
Recovery From Plantar Heel Pain Using the Fascial Distortion Model a Pilot Study
Description

To assess feasibility and determine preliminary efficacy of Fascial Distortion Model (FDM) for plantar heel pain (PHP) in a pilot study. The FDM is a hands on direct technique that is non-invasive and has been shown in preliminary studies to be effective in treating musculoskeletal (MSK) injuries. Study participants will be Active Duty Service Members (SM) in the Fort Gordon catchment area.

COMPLETED
An Evaluation of a Customized Insole to Provide Relief From Heel Pain Due to Plantar Fasciitis or General Heel Pain When Used in Footwear Over a Period of Four Weeks
Description

The primary objective of this trial will be to demonstrate the ability of a 3/4 length foam insole to provide relief from pain due to plantar fasciitis or general heel pain when used in footwear over a 4-week period of time

Conditions
COMPLETED
Study of Low Level Laser Light Therapy to Improve Blood Circulation in People With Chronic Heel Pain
Description

The purpose of this study is to determine whether low level laser light therapy is effective in increasing local blood circulation in people with chronic heel pain arising from plantar fasciitis.

COMPLETED
Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain
Description

Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical therapy practice and often is associated with chronic symptoms, and disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of care for PHP. Two practice guidelines are available to direct management patterns, but the guidelines and recent evidence of PHP interventions are unclear about the timing and influence of physical therapy in the multidisciplinary management of PHP. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP. It is hypothesized that there will be greater improvement and/or reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment provided in the uPOD group will reflect usual management patterns and intervention will be determined by the podiatrist. Treatment provided in the ePT group will be determined by the physical therapist and will focus on impairment-based manual therapy and exercise to the lower half of the body. In addition, evidence-based pain modulating modalities will be integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle Ability measure (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale (NPRS), Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The association between successful outcome based on GROC score and patient expectation of physical therapy or podiatry, and general expectations of symptom improvement will be analyzed. The results of this investigation will help to determine the impact of ePT to inform practice, update existing guidelines to reduce practice variation, and identify the most cost effective treatment for patients with PHP.

COMPLETED
Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
Description

The purpose of this study is to determine whether the Erchonia HPS Laser is effective in the treatment of chronic heel pain arising from plantar fasciitis.

COMPLETED
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Description

This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate the reduction in heel pain associated with three types of orthoses. It is hypothesized that custom made orthoses will significantly decrease pain and improve foot function in comparison to prefabricated insoles and sham insoles.

COMPLETED
Validation of a Novel Foot Offloading Device
Description

Pressure offloading is often considered the most crucial aspect in healing after a foot injury. The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where there is foot pain, as well as allow for customizable arch support and elevation of the metatarsals. This validation study is aimed to assess improvement of pain with use, ease of use, fit and feel, compliance, and durability over a 4 week period. Validated patient reported outcome measures will be used at baseline, 2 weeks and 4 weeks.

COMPLETED
Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement
Description

This is a research study to evaluate the outcomes after the study procedure for pain and discomfort in the heel caused from an injury in the Achilles tendon which is located on the back of the foot (commonly called "Achilles tendinitis"-Achilles tendinosis) that has not gotten better with medicine and/or other therapy. Researchers want to see if using the study device changes outcomes for 1 year after the study procedure.

COMPLETED
Topical Phytoterpenes for Plantar Fasciitis
Description

Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. Analog pain scores will be assessed at the start of treatment and at two weeks. Analysis will be by student's T-test.

UNKNOWN
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
Description

The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.

COMPLETED
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Description

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of Plantar Fasciitis.

COMPLETED
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Description

Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

COMPLETED
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Description

The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.

UNKNOWN
RCT Comparing ESWT With PRP for Plantar Fasciitis in High Demand Cohort
Description

A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with Platelet Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with Resistant Plantar Fasciitis

COMPLETED
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Description

Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

WITHDRAWN
Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
Description

To determine the magnitude of improvement for pain and function symptoms over a two year period after enrollment into the registry study in patients presenting with chronic heel pain and receiving standard of care treatment. Standard of care will include traditional conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel debridement and/or surgical release.

COMPLETED
Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports
Description

The overall purpose of this study is to examine the combined effect of both dorsiflexion night splints and medial arch supports and compare it to the effect of these interventions each by itself in the treatment of plantar fasciitis.

COMPLETED
Plantar Fasciosis Treatment Using Coblation
Description

The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recurring plantar fasciosis and, secondarily, to determine whether there may be additional potential benefits stemming from its use.

COMPLETED
Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome
Description

The purpose of this study is to determine if the Storz Duolith SD1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies.

COMPLETED
BGS Neonatal Pilot Study
Description

This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.

COMPLETED
Breast Milk vs Sucrose in Relieving Procedural Pain in Preterm Neonates During Blood Draw by Automated Heel Lance
Description

Skin breaking procedure through an automated heel lancet for blood draws is a common painful procedure in the Neonatal Intensive care unit (NICU). Recurrent pain in preterm neonates is associated with long-term complications. The primary objective of the study is to compare pain scores between two groups (24% sucrose and breast milk) during blood draw using an automated heel lancet in preterm neonates. The investigator conducted a prospective randomized controlled trial in preterm neonates, to compare the pain scores in infants receiving either breast milk or sucrose. Premature Infant pain profile- Revised pain profile is used to assign pain scores. The primary outcome measure is the comparison of pain scores between the two groups.

Conditions