A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in VAS score
研究概览
简要总结
For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is anticipated that the Cingal infiltration will have a greater analgesic effect than a simple cortisone infiltration in patients with moderate to severe osteoarthritis of the shoulder.
Method:
- Randomized controlled trial
- Monocentric
- Randomization will be done using sealed envelopes
详细描述
Osteoarthritis is a degenerative joint disease. The progressive erosion of cartilage generates inflammation, pain, and progressive deterioration of joint mobility. Synthetic molecules similar to hyaluronic acid have made it possible to offer patients the option of visco-supplementation by intra-articular injection. It decreases inflammation and pain. CINGAL (Anika Therapeutics, Inc., Bedford, MA), which combines the lubricating action of hyaluronic acid and the anti-inflammatory action of triamcinolone hexacetonide, is one of the available treatments. Several studies have demonstrated the effectiveness of hyaluronic acid in the relief of gonarthrosis. However, the efficacy between an infiltration of hyaluronic acid combined with triamcinolone and a corticosteroid infiltration for glenohumeral osteoarthritis is hardly reviewed in scientific studies.
Primary objective: To compare the analgesic effect of two different infiltrations.
Secondary outcome: To evaluate the patient's functional ability
It is anticipated that a CINGAL infiltration will have a greater beneficial effect than a simple cortisone infiltration in patients with mild to severe shoulder OA.
84 patients with moderate to severe shoulder osteoarthritis will be recruited to receive intra-articular infiltration of CINGAL or cortisone. The infiltration will be randomly assigned. A standard x-ray and magnetic resonance imaging examination will be performed before the infiltration. Demographic data, medical history and 2 questionnaires will be completed prior to infiltration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •A clinical examination that confirms the radiological diagnosis of moderate to severe primary shoulder osteoarthritis, stage II and above, according to the Samilson-Prieto classification.
- •Patients aged between 20 and 90 years.
- •A patient with bilateral shoulder osteoarthritis will choose the side of the infiltration, only one side can be chosen to participate in the study.
- •The patient must have a clinical pain threshold of a minimum of 4/10 on the visual analogue scale.
- •The patient must have the cognitive ability to read and fill out the questionnaires.
- •The patient must be able to read and understand French or English
排除标准
- •Presence of a transfixing rotator cuff tear assessed on MRI.
- •No previous shoulder reconstruction surgery.
- •Pregnant woman.
- •A patient who has received a cortisone infiltration within 6 months prior to the start of the study.
- •A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study.
- •Diagnosis of avascular necrosis.
- •Disease affecting the studied joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.)
- •Suspicion or presence of active local infectious process.
- •Presence or suspicion of neoplasia or local metastasis.
- •Severe trauma to the shoulder ( ≤ 3 months)
- •Significant cognitive impairment or insufficient language proficiency to adequately answer the questionnaires.
- •Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection.
研究组 & 干预措施
Cingal
A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide
干预措施: Triamcinolone Hexacetonide and hyaluronic acid (Drug)
Cortisone
A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25%
干预措施: Triamcinolone Hexacetonide (Drug)
结局指标
主要结局
Change in VAS score
时间窗: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain
次要结局
- Change in VAS score(Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration)
- Change in QuickDash disability/symptoms score(Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration)
- Change QuickDash disability/symptoms score(Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration)
- Change in QuickDash Sport/Music score(Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration)
- Change in QuickDash Work score(Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration)