Intra-articular Corticosteroid With Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP) - 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
- 100
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Hip pathologies that cause pain and functional limitations are common in the general population. These can include femoroacetabular impingement (FAI), labral tears and mild osteoarthritis (OA) among others. While more severe and symptomatic cases may require surgical intervention, the treatment of mild-to-moderate cases is often treated without surgery to relieve pain, improve function, and delay surgical intervention.
Non-operative treatments of hip pathologies consist of a multitude of options. A common non-operative intervention includes intra-articular injections, including corticosteroids and hyaluronic acid. Evidence has demonstrated that corticosteroids have fast acting effects which tend to diminish within a few months, while hyaluronic acid has a delayed time of onset and demonstrates clinical benefit for a longer period of time. Studies have evaluated combinations of corticosteroid and hyaluronic acid, hoping to take advantage of the fast-acting relief of corticosteroid and the longer lasting benefits of corticosteroid.
Physiotherapy is also a frequent non-operative intervention used to relieve pain and increase function in patients with hip pathologies. While many studies have looked at intra-articular injections and physiotherapy as independent non-operative possibilities for hip conditions, the combined effect of these two have not received much evaluation. The purpose of this study is to evaluate the effect of physiotherapy in conjunction with a combined corticosteroid and hyaluronic acid intraarticular injection on patient outcomes when compared to a corticosteroid and hyaluronic acid intraarticular injection alone.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-60 years old.
- •Patients with mild hip arthritis (Kellgren-Lawrence grade 2 or lower) with or without a labral tear and/or femoroacetabular impingement and/or mild hip dysplasia.
- •Patients who demonstrate more than 50% reduction in hip pain following a diagnostic injection (ultrasound guided intra-articular anaesthetic only).
- •Able to subsidize private physiotherapy services.
- •Able to provide informed consent.
排除标准
- •Active infection
- •Osteonecrosis of the hip, moderate to severe arthritis (Kellgren-Lawrence grade 3 or higher), or moderate-to-severe hip dysplasia
- •Previous hip fracture, pelvic fracture, or lower limb fracture,
- •Previous surgery to the pelvis, hip or lower limb
- •Hypermobility disorder or connective tissue disease (e.g. Ehler's-Danlos syndrome, Marfan's syndrome etc.)
- •Patients with chronic low back pain and/or sciatica
- •Patients who received an intra-articular steroid hip injection within 3 months
- •Patients who have previously received a hyaluronic acid injection
- •Injuries sustained in a motor vehicle collision.
- •Injuries sustained in the workplace and have a worker's compensation claim.
- •Injuries resulting in a medico-legal dispute.
- •Patients who are pregnant of planning to become pregnant
- •Currently enrolled in a study that does not permit co-enrollment
- •Unable to obtain informed consent
- •Unable to comply with the study protocol
- •Contraindication to corticosteroid or hyaluronic acid injection
- •Prior enrollment in the study.
研究组 & 干预措施
Hyaluronic and corticosteroid injection with physical therapy
Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint. Patients will also receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.
干预措施: Hyaluronic and corticosteroid injection (Drug)
Hyaluronic and corticosteroid injection with physical therapy
Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint. Patients will also receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.
干预措施: Physical Therapy (Other)
Hyaluronic and corticosteroid injection
Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint.
干预措施: Hyaluronic and corticosteroid injection (Drug)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: 6 months post-injection
NPRS is scored by asking the patient to circle the number between 0 and 10 that fits best to their pain intensity. Zero represents "no pain" whereas the upper limit of 10 represents "worst possible pain". The patient score is determined as a score out of 10 based on where they indicate their pain falls by selecting a number between 0 and 10 which most accurately represents their pain.
次要结局
- International Hip Outcome Tool 12 item (iHOT-12)(6 months post-injection)
- EuroQol-5D-5L (EQ-5D)(6 months post-injection)
- Medication Use(6 months post-injection)
- Adverse Events(6 months post-injection)