Actively Recruiting
Efficacy of Ultrasound-monitored Meniscal Wall Betamethasone Infiltration on Pain in Degenerative Meniscal Injury: A Randomized, Double-blind, Placebo-controlled Multicenter Trial
Led by University Hospital, Toulouse · Updated on 2025-12-04
152
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying degenerative meniscal pain, a common cause of knee discomfort, to evaluate the effectiveness of corticosteroid injections guided by ultrasound. The trial compares betamethasone injections to placebo injections to determine their impact on pain relief one month after treatment. This research addresses the current uncertainty and low evidence supporting corticosteroid use for meniscal pain, following guidelines recommending medical treatment before surgery. Participants will receive a single ultrasound-guided injection into the meniscal wall, either with betamethasone (a corticosteroid) or a placebo saline solution. The injection procedure involves local anesthesia and precise needle placement using ultrasound and Doppler to avoid arteries. The study is randomized, double-blind, and multicenter, with both patients and evaluators unaware of the treatment group. Follow-ups include a visit at 1 month and phone calls at 7 days and 3 months after the injection. During the study, participants will undergo clinical evaluations and pain assessments using pain scores and the KOOS questionnaire at 1 and 3 months. Researchers will monitor adverse events and analgesic responses to assess treatment effects and safety. The trial lasts at least 3 months with multiple touchpoints for symptom and function evaluation to provide objective evidence on the value of corticosteroid infiltration for degenerative meniscal pain.
CONDITIONS
Brief Title
Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Localized knee pain with tenderness over the medial or lateral joint space reproduced on clinical examination
- Pain with a VAS score greater than 4/10 despite use of tier I or II analgesics or NSAIDs
- MRI of the knee performed within 6 months before inclusion
- Medial or lateral degenerative meniscal lesion on MRI consistent with pain, confirmed by an investigator
- Affiliation to the Social Security
- Signed free and informed consent by the patient
You will not qualify if you...
- Patient under curatorship, guardianship, or safeguard of justice
- Inability to speak, read, or write French fluently
- Patient deprived of liberty
- Patients with psychiatric pathology
- MRI showing unstable meniscal lesion or recent ligament injury
- History of knee trauma less than 3 months ago
- History of knee arthroscopy or open surgery
- Corticosteroid injection in the knee within 3 months before inclusion
- Use of NSAIDs or oral corticosteroids during 48 hours before inclusion
- Use of tier 3 analgesics for knee pain in 3 months prior to inclusion
- Episodes of knee instability or true locking
- Radiographic gonarthrosis with Kellgren Lawrence stage greater than 1 within last 6 months
- Known inflammatory rheumatism
- Fibromyalgia as determined by investigator
- Pregnancy or breastfeeding
- Contraindications to corticosteroids or lidocaine
- Patients on anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 pre-inclusion telephone visit at least 7 days before inclusion
Duration - Single day
Participants receive a single ultrasound-guided injection of either betamethasone or placebo into the meniscal wall to treat meniscal pain.
1 inclusion, randomization, and infiltration visit (in-person)
Duration - 3 months
Participants are monitored for pain relief and side effects after the injection through follow-up visits and phone calls.
1 in-person visit at 1 month and 2 phone calls at 7 days and 3 months
Trial Site Locations
Total: 1 location
1
UHToulouse
Toulouse, France
Actively Recruiting
Research Team
M
Marie FARUCH, MD
V
Virginie SICART
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2