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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental |
| |
| Control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound-guided injections of hyaluronic acid plus high-power laser therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the Harris Hip Score (HHS) | - 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Alessandro de Sire | Contact | +393297219090 | alessandro.desire@unicz.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University "Magna Graecia "of Catanzaro | Recruiting | Catanzaro | CZ | 88100 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 13, 2025 |
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|
| ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy | Procedure | 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. |
|
| University "Magna Graecia "of Catanzaro | Recruiting | Catanzaro | 88100 | Italy |
|
| Jun 13, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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