Comparison of the Pain and Functional Improvement of Combined Extracorporeal Shockwave Therapy With or Without Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injection on Advanced Osteoarthritis of the Knees.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- VAS（Visual Analogue Scale）
研究概览
简要总结
This was a single group, double-blind, randomized clinical trial that enrolled 48 patients with Kellgren-Lawrence grade II to IV osteoarthritis of the knee. Patients were randomly assigned to three groups: Saline + ESWT (S+E group), High Platelet-Rich Plasma (PRP + ESWT (P+E group), and Hyaluronic Acid + ESWT (HA + ESWT (H+E group). All patients were followed for one year. Assessments included the Visual Analogue Scale (VAS), serum enzyme-linked immunosorbent assay (ELISA), knee X-ray and ultrasound examinations, and functional scores (WOMAC, KOOS, and IKDC).
详细描述
This is a double-blind trial. The first year's work primarily involves patient enrollment, treatment, and evaluation. We anticipate enrollment will take one year; therefore, patients meeting the inclusion criteria will be gradually enrolled during the first year. Upon enrollment, each patient will undergo blood tests, functional assessments, X-rays, and ultrasound examinations as pre-treatment data. After treatment (depending on their assigned group), functional assessments will be performed every three months, and X-rays and ultrasound examinations will be conducted six months later. The entire treatment period for each patient is one year (6 months of treatment + 6 months of follow-up).
Extracorporeal shock wave therapy (ESWT) is a single high-amplitude sound wave generated by a high-voltage capacitor spark discharge explosion and then focused on the area we want to treat through an elliptical reflector.
Hyaluronic acid is a long-chain polymer composed of disaccharide molecules of D-glucuronic acid and N-acetylglucosamine. It is a major component of the extracellular matrix and is widely present in human body fluids and tissues, including the vitreous humor of the eye and synovial fluid of joints. During osteoarthritis, the concentration and molecular weight of endogenous hyaluronic acid decrease significantly, leading to a decline in its effectiveness in lubricating joints and dispersing intra-articular pressure . Exogenous hyaluronic acid supplementation is effective in anti-inflammatory effects, stimulating the regeneration of endogenous hyaluronic acid, and relieving pain. Current literature confirms that intra-articular injection of hyaluronic acid can be considered as a treatment option to relieve osteoarthritis when other conservative treatments are ineffective .
On the other hand, platelet-rich plasma (PRP) is an emerging treatment option for osteoarthritis of the knee (9). PRP is plasma rich in platelets that can be separated from the patient's own blood using centrifugation. Platelets are organelles in the human body that readily obtain growth factors; therefore, high-concentration platelet plasma also contains many growth factors, including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor (TGF). These high concentrations of growth factors can be used to achieve tissue repair and regeneration. Previous literature has also confirmed that PRP can effectively reduce pain and improve function in patients with osteoarthritis. However, the effects of these two treatment methods on cartilage tissue improvement remain inconclusive.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 years and older with phase II, III, or IV osteoarthritis of the knee. The phase of osteoarthritis of the knee is defined according to the Kellgren-Lawrence classification; phase II: Only slight narrowing of the joint cavity, with visible bone spurs.
- •phase III: Numerous bone spurs, significant narrowing of the joint cavity, and subchondral cysts visible in the subchondral bone.
- •phase IV: Larger and more prominent bone spurs, severe narrowing of the joint cavity, sclerosis of the subchondral bone, and even joint deformities.
排除标准
- •Pregnant or breastfeeding women.
- •Patients with arrhythmia or those with pacemakers.
- •Patients with tumors.
- •Individuals with coagulation disorders.
- •Patients with chronic renal failure (glomerular filtration rate < 60).
- •Patients with known allergies to hyaluronic acid, or those with infections or skin diseases.
研究组 & 干预措施
ESWT+normal saline
Each group received ESWT treatment and an injection of Saline as a placebo to prevent participants from knowing they were in the control group.
干预措施: Extracorporeal Shock Wave Therapy (Device)
ESWT+normal saline
Each group received ESWT treatment and an injection of Saline as a placebo to prevent participants from knowing they were in the control group.
干预措施: Normal Saline (Drug)
ESWT+Hyaluronic Acid(HA)
This group of patients will receive ESWT and HA injections.
干预措施: Extracorporeal Shock Wave Therapy (Device)
ESWT+Hyaluronic Acid(HA)
This group of patients will receive ESWT and HA injections.
干预措施: Hyaluronic Acid (HA) (Drug)
ESWT+Platelet-Rich Plasma(PRP)
This group of patients will receive ESWT and PRP injections.
干预措施: Extracorporeal Shock Wave Therapy (Device)
ESWT+Platelet-Rich Plasma(PRP)
This group of patients will receive ESWT and PRP injections.
干预措施: Platelet-Rich Plasma (Biological)
结局指标
主要结局
VAS（Visual Analogue Scale）
时间窗: Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.
VAS（Visual Analogue Scale）：Ask the patient to mark the degree of their pain on a 10 cm line, from "no pain" on the far left to "unbearable pain" on the far right. The "Numerical Rating Scale" uses a numerical concept of 0-10 points to express the degree of pain, from no pain (0 points) to very painful (10 points).
WOMAC(Western Ontario and McMaster Universities Arthritis Index)
时间窗: Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.
WOMAC is a standardized questionnaire specifically designed to assess the symptoms and functional status of osteoarthritis (degenerative joint disease) of the knee and hip. WOMAC contains 24 items, divided into three categories. Pain (5 items): Assess the degree of pain when walking, climbing stairs, lying down, sitting, or standing. Score range: 0 to 20. Stiffness (2 items): Assess the feeling of stiffness in the joints upon waking in the morning and after resting during the day. Score range: 0 to 8. Physical Function (17 items): Assess the difficulty of performing daily activities such as climbing stairs, getting up, bending over, walking, putting on socks, and doing housework. Score range: 0 to 68.The Likert scale was used for scoring：0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for very severe. Total score: The sum of the three scores ranges from 0 to 96. A higher score indicates more severe arthritis symptoms and greater functional impairment.
KOOS scale (Knee Injury and Osteoarthritis Outcome Score)
时间窗: Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.
The KOOS scaleis a standardized questionnaire used to assess the subjective symptoms and quality of life of patients with knee injuries and osteoarthritis. KOOS contains 42 items, independently assessing the following five subscales: 1. Pain: Assessing the frequency and severity of knee pain. 2. Other symptoms: Including swelling, clicking, limited extension or flexion, etc. 3. Daily Living Functions : Ease of performing everyday actions such as going down stairs, sitting down, and putting on socks. 4. Sport/Rec: Performance in activities such as running, jumping, kneeling, or squatting.5. Quality of Life : The psychological impact and distress caused by knee condition on daily life. Scoring Method: Each item is scored on a Likert scale from 0 to 4. Score Range: Each of the five categories is calculated independently and converted to a percentage scale from 0 to 100. Score Meaning: 0 represents the worst knee condition, extremely severe; 100 represents no symptoms and excellent knee
IKDC (International Knee Documentation Committee Subjective Knee Form)
时间窗: Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.
IKDC is suitable for patients with various knee joint conditions (such as ligament injuries, meniscus tears, cartilage problems, or osteoarthritis), and is particularly commonly used for sports injuries and post-operative follow-up. It covers three main categories: symptoms (pain, stiffness, swelling, locking, or weakness. Assess three core symptom categories: assess frequency and severity of pain, stiffness, swelling, joint locking, or knee displacement. Assess sports and activities: assess limitations in daily activities (such as climbing stairs, standing up from a chair, squatting) and during movement or jumping. Assess current overall knee function: the patient's rating of their current knee condition compared to before the injury. Scoring and Interpretation: Score range: 0 to 100. Meaning: Higher scores indicate better function and fewer symptoms; 100 points indicates no symptoms and no limitations in daily life or sports.
次要结局
- Enzyme-Linked Immunosorbent Assay(Functional assessments were performed at months 0, 6, and 12 of the treatment course.)