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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ultrasound-guided injections of hyaluronic acid plus high-power laser therapy, ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy.
- Who it may be relevant to
- Registry conditions: Hip Osteoarthritis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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: a Randomized Controlled Trial
Overview
High-power laser therapy (HPLT) is effective in treating musculoskeletal conditions, reducing pain and improving joint functionality. This randomized controlled trial (RCT) aimed to explore the effectiveness of a combination of HPLT, hyaluronic acid injections, and rehabilitation for patients with hip osteoarthritis.
Detailed description
This RCT enrolled adults over 18 with a diagnosis of hip osteoarthritis (stages 1-3) who experience hip pain of 4 or higher on a scale. Participants must have a BMI under 30. Patients were randomly assigned to either a study or control group, with both patients and assessors blinded to the treatment. The study group received hyaluronic acid injections, physiotherapy, and active HPLT, while the control group received the same management, except for sham HPLT. We used the Harris Hip Score (HHS) as primary outcome to assess hip function-ing, and as secondary outcomes the following ones: Numeric Rating Scale (NRS) for pain, Eu-roQoL (EQ-5D) for quality of life, and the 6-minute walking test for physical performance. Eval-uations were conducted at multiple timepoints: baseline (T0), post-treatment (T1), and follow-ups at 3 months (T2), 6 months (T3), and 12 months (T4) after the first visit. 57 patients were ran-domly assigned to either a study group (28 patients) or a control group (29 patients).
Interventions
- Procedure 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. - Procedure 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.
Primary outcome measures
- the Harris Hip Score (HHS) [Time frame: - T0: Baseline ; - T1: 2 week from the baseline ; - T2: 3 months from the baseline; - T3: 6 months from the baseline; - T4: 12 months from the baseline.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- University "Magna Graecia "of Catanzaro — Catanzaro
- University "Magna Graecia "of Catanzaro — Catanzaro
Identifiers
NCT: NCT07108400 · 429/2021