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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2025-12-12

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Study group

Group Type EXPERIMENTAL

ultrasound-guided injections of hyaluronic acid plus high-power laser therapy

Intervention Type 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.

Control group

Group Type SHAM_COMPARATOR

ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy

Intervention Type 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.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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De Sire Alessandro

OTHER

Sponsor Role lead

Responsible Party

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De Sire Alessandro

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University "Magna Graecia "of Catanzaro

Catanzaro, CZ, Italy

Site Status RECRUITING

University "Magna Graecia "of Catanzaro

Catanzaro, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Professor Alessandro de Sire

Role: CONTACT

+393297219090

Facility Contacts

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Professor Alessandro de Sire

Role: primary

+393297219090

alessandro de Sire Professor Alessandro de Sire

Role: primary

+393297219090

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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429/2021

Identifier Type: -

Identifier Source: org_study_id

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