Extracorporeal Shock Wave Therapy in Patients With Knee Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- recovery of pain
研究概览
简要总结
Pathological arthritis is a degenerative disease affecting the joints, characterized by pain, limitation of movement up to ankylosis and disability. Treatment is aimed at reducing pain and slowing the loss of functionality of the district. Among conservative treatments, pharmacological options (NSAIDs, cortisone, contrasupplements, hyaluronic acid) and non-pharmacological options (therapeutic exercise, physical therapy, orthosis, etc.) are indicated. In cases not responding to conservative treatments, surgical treatment will be necessary with prosthetic replacement of the joint district.
详细描述
In recent years, shock wave therapy has received a lot of interest in the treatment of numerous musculoskeletal pathologies. This physical therapy exploits the cavitational effect induced on the tissues which translates into neo-angiogenic, anti-inflammatory, regenerative and analgesic action. Until now, the indication has been reserved for the treatment of tendinopathies and delayed consolidation of fractures. Pre-clinical research is also paving the way for the treatment of cartilage pathologies; in fact, after the stimulation of the chondrocyte, a modulation of the phlogogenic cytokines has been found, supporting a slowing down of the progression of the arthritic pathology. The first clinical experiences on arthritic models, such as rhizarthrosis, allow to support the indication also on the pathological model of gonarthrosis. The aim of this study is to verify the effects of shock wave therapy in the patient affected by gonarthrosis, monitoring the action on pain, functionality and tissue district changes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent knee pain for at least 3 months, measured with a VAS scale of 4 or higher,
- •clinical and radiological diagnosis confirming knee osteoarthritis grade 2 and 3 based on the Kellgren-Lawrence system,
- •no history of physical therapy in the last 3 months,
- •no infections, tumors in the treatment area of the knee,
- •no pathology other than osteoarthritis that could cause knee pain,
- •no pathology of the lumbar spine or hip that could refer knee pain,
- •free from any condition that prevents participation in exercise or physical therapy willing to participate regularly in the treatment programs were included in the study.
排除标准
- •inability to walk,
- •a history of clinically symptomatic spinal stenosis or lumbar radiculopathy,
- •evidence of a neurological disorder based on history or physical examination,
- •generalized pain or fibromyalgia,
- •secondary osteoarthritis (to metabolic or rheumatologic disease),
- •administration of intra-articular injections (anesthetic, hyaluronic acid, cortisone) of the knee in the last 6 months,
- •use of NSAIDs, paracetamol or topical agents in the previous week,
- •a previous history of surgery involving the knee joint,
- •contraindications to physical therapy (PM, epilepsy, neoplasia, coagulopathy, pregnancy).
研究组 & 干预措施
Exercise Group
only a daily exercise program for 4 weeks: passive and active assisted movement of the knee joint, hamstring stretching, and quadriceps strengthening exercises
干预措施: exercise group (Other)
ESWT group
Shockwave therapy will be administered using an ESWT device (Minilith SL1, Storz) once a week for three consecutive weeks, for a total of three sessions. A focused shockwave modality with an electromagnetic device was chosen for the therapy.
干预措施: ESWT group (Device)
结局指标
主要结局
recovery of pain
时间窗: From enrollment to 1, 3 and 6 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: From enrollment to 1, 3 and 6 months
questionnaire consisting of 24 questions addressing pain, stiffness and physical function. Score from 0 to 96, higher scores correspond to worse clinical condition.
次要结局
- MR image(From enrollment to 6 months)
- Roles and Maudsley Score(At 1, 3 and 6 months)