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.
1 other identifier
interventional
57
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2022
CompletedFirst Submitted
Initial submission to the registry
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2025
CompletedFirst Posted
Study publicly available on registry
August 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2025
CompletedAugust 7, 2025
August 1, 2025
3.4 years
June 13, 2025
August 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Study group
EXPERIMENTALControl group
SHAM COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Mini-Mental State Examination (MMSE) score \< 24
- Concurrent treatment with an-ti-inflammatory drugs or rehabilitation therapies; Rheumatoid arthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University "Magna Graecia "of Catanzaro
Catanzaro, CZ, 88100, Italy
University "Magna Graecia "of Catanzaro
Catanzaro, 88100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 13, 2025
First Posted
August 7, 2025
Study Start
March 17, 2022
Primary Completion
August 3, 2025
Study Completion
December 12, 2025
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share