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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- the Harris Hip Score (HHS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Mini-Mental State Examination (MMSE) score < 24
- •Concurrent treatment with an-ti-inflammatory drugs or rehabilitation therapies; Rheumatoid arthritis.
研究组 & 干预措施
Study group
干预措施: ultrasound-guided injections of hyaluronic acid plus high-power laser therapy (Procedure)
Control group
干预措施: ultrasound-guided injections of hyaluronic acid plus sham" high-power laser therapy (Procedure)
结局指标
主要结局
the Harris Hip Score (HHS)
时间窗: - 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.
次要结局
未报告次要终点
研究者
De Sire Alessandro
professor
University of Catanzaro