Actively Recruiting
Efficacy of a Combination of Ultrasound-guided Intra-articular Injections of Hyaluronic Acid, High-power Laser Therapy and Rehabilitation on Functioning in Patients Affected by Hip Osteoarthritis: a Randomized Controlled Trial
Led by De Sire Alessandro · Updated on 2025-08-07
57
Participants Needed
2
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of combining high-power laser therapy (HPLT), hyaluronic acid injections, and rehabilitation in adults with hip osteoarthritis. This randomized controlled trial (RCT) includes patients aged 18 to 85 years with hip osteoarthritis stages 1 to 3 who experience moderate to severe hip pain. The study aims to assess improvements in pain, joint function, and physical performance. Participants are randomly assigned to either a study group or a control group in a double-blind manner. The study group receives two ultrasound-guided injections of hyaluronic acid into the hip joint, 10 physical therapy sessions over two weeks, and 10 sessions of active HPLT using a diode laser. The control group receives the same injections and physical therapy but undergoes sham HPLT that mimics the active treatment without delivering laser energy. During the study, participants undergo evaluations using the Harris Hip Score (HHS) at baseline, after two weeks, and at 3, 6, and 12 months follow-up. Additional assessments include pain rating scales, quality of life questionnaires, and a 6-minute walking test. The study monitors participants' hip function and pain levels over one year to understand the impact of the combined treatments.
CONDITIONS
Brief Title
Efficacy of a Combination of Ultrasound-guided Intra-articular Injections of Hyaluronic Acid, High-power Laser Therapy and Rehabilitation on Functioning in Patients Affected by Hip Osteoarthritis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Diagnosis of hip osteoarthritis stage 3 or lower
- Hip pain rated 4 or higher on a Numeric Rating Scale
- Body mass index (BMI) less than 30 kg/m²
- Not currently taking anti-inflammatory drugs, opioids, corticosteroids, muscle relaxants, or other therapies affecting study assessments
You will not qualify if you...
- Mini-Mental State Examination (MMSE) score less than 24
- Current treatment with anti-inflammatory drugs or rehabilitation therapies
- Diagnosis of rheumatoid arthritis
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 visit (in-person)
Duration - 2 weeks
Participants receive two ultrasound-guided injections of hyaluronic acid into the hip joint, 10 sessions of physical therapy over two weeks, and either active or sham high-power laser therapy.
10 visits (in-person) over 2 weeks
Duration - 12 months
Participants are evaluated to assess hip function, pain, quality of life, and physical performance at multiple timepoints after treatment.
4 visits at 2 weeks, 3 months, 6 months, and 12 months post-baseline
Trial Site Locations
Total: 2 locations
1
University "Magna Graecia "of Catanzaro
Catanzaro, CZ, Italy, 88100
Actively Recruiting
2
University "Magna Graecia "of Catanzaro
Catanzaro, Italy, 88100
Actively Recruiting
Research Team
P
Professor Alessandro de Sire
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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