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Study on Betamethasone Injection for Pain Relief in Adults with Degenerative Meniscal Injury

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for meniscal pain of degenerative origin, which is a type of knee pain that occurs due to wear and tear of the meniscus, a piece of cartilage in the knee. The treatment being tested is an injection of betamethasone, a medication that helps reduce inflammation and pain. The study will compare the effects of betamethasone injections to a placebo, which is an inactive substance, to see if the medication provides better pain relief.

The purpose of the study is to evaluate how effective the betamethasone injections are in reducing knee pain when guided by ultrasound, a technique that uses sound waves to create images of the inside of the body. Participants in the study will receive either the betamethasone injection or a placebo injection, and their pain levels will be monitored over a period of one month. The study will also track any changes in pain over three months and any side effects that may occur.

Participants will undergo an initial assessment, including an MRI (Magnetic Resonance Imaging) scan of the knee, to confirm the presence of a degenerative meniscal lesion. The study aims to determine if the betamethasone injection can significantly reduce pain compared to the placebo, with the primary focus on changes in pain levels measured by a Visual Analog Scale (VAS), a tool used to assess pain intensity. The study will also evaluate the overall knee function using the KOOS score, which measures knee-related quality of life.

1 initial visit

During the initial visit, the patient will undergo a clinical examination to confirm the presence of knee pain related to a degenerative meniscal injury.

An MRI scan of the knee, performed within the last three months, will be reviewed to confirm the diagnosis.

The patient’s pain level will be assessed using the Visual Analog Scale (VAS), which measures pain on a scale from 0 to 10.

2 treatment administration

The patient will receive an injection of either betamethasone or a placebo into the meniscal wall. This procedure will be guided by ultrasound to ensure accuracy.

The injection will be administered subcutaneously, which means it will be given under the skin.

3 follow-up visit at 1 month

One month after the treatment, the patient will return for a follow-up visit.

The primary goal of this visit is to evaluate the change in meniscal pain using the VAS score.

The patient’s pain reduction will be considered significant if there is at least a 50% decrease in the VAS score.

4 follow-up visit at 3 months

Three months after the treatment, another follow-up visit will be conducted.

The evolution of the VAS score and the KOOS score, which assesses knee-related quality of life, will be evaluated.

Any adverse events or serious adverse events experienced by the patient will be recorded.

Who Can Join the Study?

  • Patient must be 18 years or older.
  • Must have localized knee pain with tenderness over the inner or outer joint space, which can be felt during a physical examination.
  • Pain must be rated as more than 4 out of 10 on a pain scale, even after trying basic pain relief treatments like painkillers or non-steroidal anti-inflammatory drugs (NSAIDs).
  • Must have had an MRI scan of the knee within the last 3 months as part of the pre-treatment check-up. An MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
  • The MRI must show a degenerative meniscal lesion (a type of wear and tear in the knee) that matches the pain, confirmed by a doctor.
  • Must be affiliated with the Social Security system.
  • Must have signed a free and informed consent, meaning the patient agrees to participate after understanding the study details.

Who Cannot Join the Study?

  • Patients who have had surgery on the knee in the last 6 months cannot participate.
  • Patients with an infection in the knee area are not eligible.
  • Patients who have a known allergy to betamethasone or similar medications cannot join. Betamethasone is a type of medication used to reduce inflammation.
  • Patients who are currently participating in another clinical trial are not allowed to join.
  • Patients with a history of severe heart, liver, or kidney disease are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of blood clotting disorders are not eligible.
  • Patients who have received a steroid injection in the knee in the last 3 months cannot join.
  • Patients with a history of cancer in the last 5 years are excluded, except for certain skin cancers.
  • Patients who have a mental health condition that might affect their ability to participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Tarbes-Lourdes Tarbes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.09.2024

Trial locations

Investigated drugs:

Betamethasone is a medication used in this trial to help reduce pain associated with degenerative meniscal injuries. It is administered through an ultrasound-guided injection directly into the meniscal wall. The goal is to see if this treatment can effectively decrease pain in adults suffering from meniscal pain due to degeneration.

Degenerative Meniscal Pain – This condition involves pain originating from the meniscus, a C-shaped cartilage in the knee, due to degenerative changes. Over time, the meniscus can wear down, leading to discomfort and reduced knee function. The pain is often exacerbated by activities that involve bending or twisting the knee. As the degeneration progresses, individuals may experience increased stiffness and swelling in the knee joint. The condition is common in older adults and those with a history of knee injuries. It can significantly impact daily activities and quality of life.

Trial ID:
2023-510079-74-00
Protocol code:
RC31/23/0387
Trial Phase:
Therapeutic confirmatory (Phase III)

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