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.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Procedure: ultrasound-guided injections of hyaluronic acid plus high-power laser therapy; Procedure: ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Professor Alessandro de Sire; Phone Number: +393297219090; Email: alessandro.desire@unicz.it

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • University "Magna Graecia "of Catanzaro
    • Contact: alessandro de Sire Professor Alessandro de Sire; Phone Number: +393297219090; Email: alessandro.desire@unicz.it
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Recruiting
      • University "Magna Graecia "of Catanzaro
      • Contact: Professor Alessandro de Sire; Phone Number: +393297219090; Email: alessandro.desire@unicz.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group	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.
Experimental: Study group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: De Sire Alessandro

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Estimated): August 3, 2025
• Study Completion (Estimated): December 12, 2025

Study Registration Dates

• First Submitted: June 13, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 7, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: hyaluronic acid; functioning; hip osteoarthritis; lasertherapy; rehabilitation; pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 429/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No