Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06527235

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

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

Treatment

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)

Follow-up

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

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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

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