Ongoing Clinical Trials for Ligament Sprain
Currently, there is 1 ongoing clinical trial investigating new treatment options for ligament sprain, specifically focusing on acute ankle sprains. This trial is being conducted in Germany and is testing a topical pain relief system as an alternative to traditional oral pain medications.
Clinical trial locations
Study on Esflurbiprofen Topical System and Paracetamol for Pain Relief in Patients with Acute Ankle Sprains
This clinical trial is examining a new approach to treating acute ankle sprains through a medicated patch applied directly to the skin. The study focuses on mild ankle sprains, known as Grade I sprains, which occur when the ankle ligaments are stretched or slightly torn due to twisting or rolling movements.
Main inclusion criteria:
- Adults aged 18 to 64 years
- Must have a mild (Grade I) acute ankle sprain
- The injury must cause pain during movement
- Must join the study within 6 hours of the injury occurring
- Pain level must be at least 50 mm on a 100 mm pain scale
- Must be in satisfactory overall health
- Must provide written consent to participate
Main exclusion criteria:
- Other serious injuries to the ankle or foot
- Previous surgery on the affected ankle within the past 6 months
- History of chronic pain conditions
- Currently taking pain medications that cannot be stopped
- Allergies to the study medication or similar drugs
- Pregnancy or breastfeeding
- Severe medical conditions that could interfere with the study
- Participation in another clinical trial within the last 30 days
- Mental health conditions affecting ability to participate
- Inability to understand or follow study instructions
Study focus and goals:
The trial aims to determine whether the Esflurbiprofen Topical System (EFTS) patch is more effective at reducing pain compared to a placebo patch in people with ankle sprains. Participants will be randomly assigned to receive either the active EFTS patch or a placebo patch that looks identical but contains no active medication. The patch is applied directly to the injured area and delivers medication through the skin.
Throughout the study, participants will regularly report their pain levels at multiple time points over the course of one week. Researchers will measure how quickly the treatment reduces pain, looking specifically at meaningful pain reduction (at least 30% decrease) and optimal pain reduction (at least 50% decrease). Both participants and study doctors will assess the overall effectiveness of the treatment at various stages.
The study also allows for the use of paracetamol as rescue medication if needed to manage pain, and researchers will track when and how often this additional medication is used.
Investigational drug:
The medication being tested is the Esflurbiprofen Topical System (EFTS), which is a transdermal patch containing esflurbiprofen. This belongs to a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The patch works by delivering the medication directly through the skin to the injured area, where it reduces the production of substances in the body that cause inflammation and pain. This targeted approach aims to provide quick relief from pain when moving the ankle, potentially making it easier for patients to maintain their daily activities while the injury heals.
Summary
Currently, research into new treatments for ligament sprains is limited, with only one active clinical trial identified. This trial is being conducted in Germany and represents an innovative approach to pain management for ankle sprains by using a topical medication delivery system rather than oral medications. The focus on early intervention, requiring enrollment within 6 hours of injury, suggests an emphasis on immediate pain relief during the acute phase of injury. The study specifically targets mild sprains in adults under 65 years of age, which represents the most common type of ankle sprain seen in everyday life. The use of a skin patch may offer advantages such as delivering medication directly to the injury site while potentially reducing side effects associated with oral pain medications.