Treatment Trials

13 Clinical Trials for Various Conditions

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WITHDRAWN
The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
Description

The primary objective of this study is to evaluate the feasibility of implementing BFR in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of BFR when compared to standard treatment. This study will evaluate the efficacy of using BFR therapy for the treatment of acute grade I and II ankle sprains. The investigators will evaluate clinical outcomes of range of motion (ROM) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. This will be a small, randomized control trial study. The investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo BFR therapy for an isolated lateral ankle sprain. Patients will be randomized into control and experimental group via block randomization.

COMPLETED
Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain
Description

This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose, parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all eligibility criteria, will be randomized into the study and will receive either the active treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount equivalent to a 4 inch line of investigational product to the affected ankle approximately every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a 24 hour period. Duration of treatment with the investigational product is 7 days.

TERMINATED
Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain
Description

The purpose of this multisite randomized controlled trial (RCT) is to compare the short-term (6 week) and long-term (6 month) effect of chiropractic care combined with a specific nutritional supplement regimen to chiropractic care with a placebo supplement for patients with ankle sprains, in terms of improvement in physical function and pain.

Conditions
COMPLETED
Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department
Description

This research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.

Conditions
COMPLETED
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Description

The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Conditions
COMPLETED
A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
Description

Acute ankle sprain is one of the most common musculoskeletal injuries, accounting for an estimated 2 million injuries per year and 20% of all sports injuries in the United States. Ankle sprains can lead to prolonged periods of pain, difficulty with mobility, and lost work or play time. Current best practice guidelines for treatment of an acute ankle sprain are protection, rest, ice, compression and elevation (PRICE). However recent systematic reviews for ankle sprains call into question this treatment. Two critical components; immobilization and ice, have little or no evidence of efficacy for ankle sprain. Interestingly, mobilization appears to be more effective at reducing the pain, swelling and stiffness of musculoskeletal injuries including ankle sprains. Historically the limitation to early mobilization has been pain. Recently developed stretch bands have been introduced to the therapy market as a tool that allows pain-free active and resisted ankle movement after acute ankle sprain. The investigators propose a double blind randomized controlled study to compare 2 ankle sprain treatments on their ability to speed recovery and reduce morbidities such as pain, swelling and weakness.

Conditions
UNKNOWN
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
Description

The ROCKY REHAB trial will provide a pragmatic approach to evaluate if incorporating a rocky, uneven terrain treadmill into the proprioceptive rehabilitation received during physical therapy can improve outcomes and reduce reinjury rates in patients with ankle instability.

TERMINATED
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
Description

This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.

COMPLETED
Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Description

To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain

Conditions
COMPLETED
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Description

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.

RECRUITING
Telehealth Delivered Physical Rehabilitation for an Ankle Sprain
Description

A vast majority (75-85%) of ankle sprain patients treated in emergency departments (ED) receive pain medication and are not referred for physical rehabilitation. Therefore, purpose of this study is to increase access to the standard of care for an ankle sprain by provide patients with physical rehabilitation delivered through telehealth. The purpose of this study includes compare a 2-week telehealth intervention to the usual care for treating 1) subjective function; 2) physical impairments; 3) medication consumption; and 4) patient-perceived barriers. The central hypothesis is participants receiving the 2-week telehealth intervention will 1) have less pain and disability; 2) improve balance and ankle range of motion; 3) consume less medication; and 4) reports positive feedback compared to the usual care group.

TERMINATED
Proof-of-concept Study of NSAID Hydrogel Patch in Treatment of Acute Pain
Description

The safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in comparing with placebo in the treatment of acute pain due to ankle sprain

Conditions
COMPLETED
Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
Description

Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.