Ongoing Clinical Trials for Pain in Extremity
This article provides information about 3 ongoing clinical trials investigating treatments for pain in the extremities (arms and legs). These trials are exploring different approaches to managing pain, from degenerative knee injuries to trauma-related pain and acute pain in children. The trials are currently being conducted in France and Italy.
Clinical trial locations
- France
- Italy
Study on Betamethasone Injection for Pain Relief in Adults with Degenerative Meniscal Injury
This trial is investigating whether ultrasound-guided injections of betamethasone can effectively reduce knee pain caused by degenerative meniscal injuries. The meniscus is a piece of cartilage in the knee that can wear down over time, leading to pain and reduced function.
Who can participate: Adults aged 18 years or older with localized knee pain that can be felt during examination are eligible. Participants must have pain rated higher than 4 out of 10 even after trying basic pain relief medications like painkillers or anti-inflammatory drugs. An MRI scan performed within the last 3 months must show a degenerative meniscal lesion that matches the pain location. Participants must also be affiliated with Social Security and provide informed consent.
Who cannot participate: The trial excludes patients who have had knee surgery in the last 6 months, have a knee infection, or have a known allergy to betamethasone or similar medications. Those currently participating in another clinical trial, with severe heart, liver, or kidney disease, who are pregnant or breastfeeding, or who have blood clotting disorders are also excluded. Additionally, patients who received a steroid injection in the knee within the last 3 months or have a history of cancer in the last 5 years (except certain skin cancers) cannot join. Those with mental health conditions that might affect participation are also not eligible.
What the trial involves: The study compares betamethasone injections to placebo injections to determine if the medication provides better pain relief. Participants receive an ultrasound-guided injection into the meniscal wall and are monitored for pain changes over one month (primary outcome) and three months. Pain levels are measured using a Visual Analog Scale, and knee function is assessed using the KOOS score. The trial also tracks any side effects that may occur.
Investigational drug: Betamethasone is a corticosteroid medication that reduces inflammation and pain. It is administered directly into the meniscal wall under ultrasound guidance.
Study on Managing Moderate to Severe Limb Trauma Pain in Emergency Patients Using Sublingual Sufentanil Compared to a Drug Combination
This trial focuses on managing moderate to severe pain caused by a single injury to the arm or leg in emergency situations. The study tests a medication called sufentanil, which is placed under the tongue to dissolve, and compares its effectiveness to standard pain management treatments.
Who can participate: Adults with a pain level of 4 or higher on a scale of 0 to 10 are eligible. The pain must result from a single injury to either the upper or lower limb. Participants must be fully alert (Glasgow Coma Scale score of 15) and have adequate oxygen levels in their blood (oxygen saturation above 95% when breathing normal air). Both male and female patients can participate.
Who cannot participate: The trial excludes patients who have experienced trauma to the limbs but fall outside the specified age range. Those belonging to vulnerable populations who might need special protection or care are also excluded.
What the trial involves: The study evaluates how quickly sublingual sufentanil relieves pain compared to standard emergency pain management. Pain levels are measured at multiple time points: initially, then at 15, 30, 45, 60, 120, and 180 minutes after medication administration. The primary focus is on pain change between the initial assessment and 60 minutes later. Throughout the trial, researchers monitor for side effects including low blood pressure, slow heart rate, breathing difficulties, sweating, drowsiness, nausea, vomiting, and dizziness. At the end of the study period, patients rate their satisfaction with the pain management received.
Investigational drug: Sufentanil is an opioid analgesic that binds to opioid receptors in the brain to reduce pain perception. It is administered sublingually (under the tongue) for quick absorption and rapid pain relief.
Study Comparing the Speed of Action of Ibuprofen Lysine and Ibuprofen in Treating Acute Pain in Children
This trial compares two forms of ibuprofen to determine which works more quickly in relieving acute pain in children. The study tests ibuprofen lysine suspension against standard ibuprofen suspension.
Who can participate: Children aged 4 to 12 years who have been admitted to the emergency room with acute pain are eligible. The pain may be the main symptom or accompany other conditions such as sore throat, headache, ear pain, toothache, or injury-related pain. Children must have a pain level of 4 or higher on an age-appropriate scale of 1 to 10. Written informed consent must be provided by parents or guardians, and children must also provide their own consent if able. Participants must be willing and able to follow study requirements.
Who cannot participate: Children outside the age range of 2 to 12 years cannot participate. Those with other serious health conditions that might interfere with the study, currently taking medications that might affect results, or with allergies to ibuprofen or similar medications are excluded. Children with a history of stomach problems (such as ulcers or bleeding), kidney or liver problems, or asthma worsened by aspirin or other anti-inflammatory drugs cannot join. Those already participating in another clinical trial are also excluded.
What the trial involves: The study is conducted in a single-blind manner, meaning participants do not know which medication they receive. This helps ensure unbiased results. Pain levels are assessed using age-appropriate scales such as the Wong-Baker Faces Pain Scale and the Numerical Rating Scale. The primary assessment occurs five minutes after medication administration, with additional assessments at 10, 20, and 30 minutes to evaluate overall pain relief. Throughout the study, children are monitored for any adverse effects to ensure their safety.
Investigational drugs: Lysin ibuprofen suspension contains ibuprofen with the addition of lysin, which is intended to help the medication be absorbed faster by the body for quicker pain relief. Standard ibuprofen suspension is a common pain reliever and anti-inflammatory medication used to reduce fever and relieve pain. Both are nonsteroidal anti-inflammatory drugs (NSAIDs) that work by inhibiting enzymes responsible for producing substances that cause pain and inflammation in the body.
Summary
These three clinical trials represent diverse approaches to managing pain in the extremities across different patient populations. Two trials are being conducted in France, focusing on adult pain management for degenerative knee conditions and traumatic limb injuries in emergency settings. One trial is taking place in Italy, concentrating on acute pain relief in children.
The trials test various medication types and delivery methods, from corticosteroid injections for chronic degenerative conditions to fast-acting opioid analgesics for emergency trauma pain, and comparing formulations of over-the-counter pain relievers for pediatric use. Each study employs different assessment methods appropriate to its target population, including visual analog scales for adults and age-appropriate pain scales for children.
The diversity of these trials reflects the complexity of pain management in extremities, with treatments tailored to specific causes, patient ages, and clinical settings. Results from these studies may help healthcare providers better understand which medications and delivery methods work most effectively for different types of limb pain.
