ClinicalTrials.Veeva

Menu

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.

D

De Sire Alessandro

Status

Enrolling

Conditions

Hip Osteoarthritis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07108400
429/2021

Details and patient eligibility

About

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.

Full 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).

Enrollment

57 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

57 participants in 2 patient groups

Study group
Experimental group
Treatment:
Procedure: ultrasound-guided injections of hyaluronic acid plus high-power laser therapy
Control group
Sham Comparator group
Treatment:
Procedure: ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy

Trial documents
1

Trial contacts and locations

2

Loading...

Central trial contact

Professor Alessandro de Sire

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems