Combining ultrasound-guided hyaluronic acid injections, high-power laser therapy, and rehabilitation for hip osteoarthritis
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
NA · University of Catanzaro · NCT07108400
This trial will test whether adding high-power laser therapy to ultrasound-guided hyaluronic acid injections and physiotherapy improves pain and hip function in adults with stage 1–3 hip osteoarthritis and BMI under 30.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Catanzaro (other) |
| Locations | 2 sites (Catanzaro, CZ and 1 other locations) |
| Trial ID | NCT07108400 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind controlled trial enrolled 57 adults with Kellgren-Lawrence stage 1–3 hip osteoarthritis, pain ≥4/10, and BMI <30 at the University Magna Graecia of Catanzaro. Participants were randomly assigned to receive ultrasound-guided hyaluronic acid injections plus active high-power laser therapy and rehabilitation, or the same care with a sham laser intervention. The primary outcome was the Harris Hip Score, with secondary outcomes including the Numeric Rating Scale for pain, EQ-5D quality-of-life, and the 6-minute walk test, measured at baseline, post-treatment, and at 3, 6, and 12 months. Blinding of patients and assessors and repeated follow-up allowed comparison of function, pain, and physical performance over one year.
Who should consider this trial
Good fit: Adults over 18 with stage 1–3 hip osteoarthritis, hip pain ≥4/10, BMI under 30, and who can suspend interfering medications and therapies are the intended participants.
Not a fit: Those with severe (stage 4) hip osteoarthritis, BMI ≥30, inflammatory arthritis, cognitive impairment (MMSE <24), or who cannot stop interfering medications are unlikely to match the study population and may not benefit.
Why it matters
Potential benefit: If successful, the combined treatment could reduce hip pain and improve walking ability and overall hip function for people with mild-to-moderate hip osteoarthritis.
How similar studies have performed: High-power laser therapy and hyaluronic acid injections individually have shown benefits for pain or function in musculoskeletal and osteoarthritis contexts, but randomized data on this specific combination with rehabilitation are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years * Diagnosis of hip OA (stage ≤ 3 according to the Kellgren and Lawrence classification) * Hip pain assessed with the Numeric Rating Scale ≥ 4 * Body mass index (BMI) less than 30 kg/m² * Suspension of anti-inflammatory drugs (NSAIDs), opioids, corticosteroids, muscle relaxants or any other therapy that could interfere with the study assessments. Exclusion Criteria: * Mini-Mental State Examination (MMSE) score \< 24 * Concurrent treatment with an-ti-inflammatory drugs or rehabilitation therapies; Rheumatoid arthritis.
Where this trial is running
Catanzaro, CZ and 1 other locations
- University "Magna Graecia "of Catanzaro — Catanzaro, CZ, Italy (RECRUITING)
- University "Magna Graecia "of Catanzaro — Catanzaro, Italy (RECRUITING)
Study contacts
- Study coordinator: Professor Alessandro de Sire
- Email: alessandro.desire@unicz.it
- Phone: +393297219090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Osteoarthritis, lasertherapy, hyaluronic acid, hip osteoarthritis, functioning, rehabilitation, pain