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.
NCT ID: NCT07108400
Last Updated: 2025-08-07
Study Results
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Basic Information
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RECRUITING
NA
57 participants
INTERVENTIONAL
2022-03-17
2025-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study group
ultrasound-guided injections of hyaluronic acid plus high-power laser therapy
Received two ultrasound-guided injections of hyaluronic acid into the coxo-femoral joint, 10 sessions of physical therapy specifically targeting hip OA (5 sessions/week for two weeks) lasting 45 minutes, and 10 sessions of active high-power laser therapy using a diode laser.
Control group
ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy
Received two ultrasound-guided injections of hyaluronic acid into the coxo-femoral joint, 10 sessions of physical therapy specifically targeting hip OA (5 sessions/week for two weeks) lasting 45 minutes, and 10 sessions of "sham" high-power laser therapy using a diode laser, due to the presence of a light pointer and an acoustic signal of the device, which made it impossible to distinguish the active treatment from the sim-ulated one.
Interventions
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ultrasound-guided injections of hyaluronic acid plus high-power laser therapy
Received two ultrasound-guided injections of hyaluronic acid into the coxo-femoral joint, 10 sessions of physical therapy specifically targeting hip OA (5 sessions/week for two weeks) lasting 45 minutes, and 10 sessions of active high-power laser therapy using a diode laser.
ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy
Received two ultrasound-guided injections of hyaluronic acid into the coxo-femoral joint, 10 sessions of physical therapy specifically targeting hip OA (5 sessions/week for two weeks) lasting 45 minutes, and 10 sessions of "sham" high-power laser therapy using a diode laser, due to the presence of a light pointer and an acoustic signal of the device, which made it impossible to distinguish the active treatment from the sim-ulated one.
Eligibility Criteria
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Inclusion Criteria
* 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
* Concurrent treatment with an-ti-inflammatory drugs or rehabilitation therapies; Rheumatoid arthritis.
18 Years
85 Years
ALL
No
Sponsors
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De Sire Alessandro
OTHER
Responsible Party
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De Sire Alessandro
professor
Locations
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University "Magna Graecia "of Catanzaro
Catanzaro, CZ, Italy
University "Magna Graecia "of Catanzaro
Catanzaro, , Italy
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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429/2021
Identifier Type: -
Identifier Source: org_study_id
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