The Efficacy of Ultrasonication in Combination With Corticosteroid Intraarticular Injection for Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital
About this trial
This study investigates whether ultrasound therapy applied prior to intra-articular corticosteroid injection can enhance the treatment efficacy for patients with joint arthritis and assess its safety. Adult patients diagnosed with arthritis in the limbs who are indicated for corticosteroid injection are eligible, while patients with joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis are excluded.
Ultrasound therapy is a valuable physical therapy tool for musculoskeletal diseases, producing therapeutic effects through thermal and non-thermal mechanisms. It can improve tissue extensibility, reduce joint stiffness, increase local blood flow, enhance metabolism during tissue repair, and facilitate drug absorption. This study evaluates whether applying ultrasound before intra-articular corticosteroid injection improves therapeutic outcomes in patients with arthritis, and assesses the safety of this combined intervention. Patients aged 18 or older, diagnosed with limb arthritis, and indicated for corticosteroid injection are eligible. Exclusion criteria include joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis at the treatment site.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Diagnosed with arthritis in the limbs.
Inadequate response to or contraindication for oral anti-inflammatory medications.
Assessed by a physician as requiring intra-articular corticosteroid injection.
Disqualifiers
History of joint replacement (prosthetic joint) in the affected area.
Hip joint involvement.
Diagnosis of gout.
Infectious arthritis.
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic Ultrasound
DeviceTherapeutic Ultrasound (TUS) is a non-invasive treatment widely used in physical medicine and rehabilitation for musculoskeletal conditions. Since its introduction in the mid-20th century, TUS has gained popularity in clinical practice due to its ability to penetrate tissues, target treatment areas precisely, and exhibit minimal side effects. This study aims to investigate the mechanisms of action, clinical efficacy, and safety of therapeutic ultrasound in musculoskeletal therapy.
Intra-articular corticosteroid injection
Procedure/SurgeryInjection of triamcinolone (3-50 mg depending on joint size) into the affected joint. Administered once per participant.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ultrasonication in combination with corticosteroid intraarticular injectionExperimental treatment 2 interventions
Group B: corticosteroid intraarticular injectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduction in Synovial Swelling Area Assessed by Joint Ultrasound
Synovial swelling area (pixels) assessed by joint ultrasound. A treatment response is defined as a ≥50% reduction in synovial swelling area from baseline.
Time frame
From enrollment to the end of treatment at 2 weeks2
Change in Power Doppler (PD) Score of the Target Joint
Power Doppler (PD) score (range 0-3) of the target joint assessed by joint ultrasound. A treatment response is defined as a PD score of 0 at 2 weeks post-treatment.
Time frame
From enrollment to the end of treatment at 2 weeks3
Change in Pain Visual Analogue Scale (VAS)
Pain intensity assessed using a visual analogue scale (VAS 0-10). A treatment response is defined as a ≥50% reduction in VAS score from baseline or a VAS score ≤1 at 2 weeks post-treatment.
Time frame
From enrollment to the end of treatment at 2 weeksSecondary outcomes
1
Absence of Synovitis Recurrence Based on Power Doppler (PD) Score
Absence of synovitis recurrence assessed by Power Doppler (PD) ultrasound. Recurrence is defined as any increase in PD score compared with the 2-week post-treatment assessment.
Time frame
From enrollment to 3 months post-treatment2
Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound
Absence of synovial swelling recurrence assessed by gray-scale ultrasound. Recurrence is defined as an increase in synovial swelling area of ≥20% compared with the 2-week post-treatment assessment.
Time frame
From enrollment to 3 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov