Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Symptom severity in post-intervention assessments
研究概览
简要总结
This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment
- •conservative treatment of tennis elbow is recommended as standard of care treatment
- •over the age of 18 and under the age of 65
- •ability to give informed consent
排除标准
- •treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow
- •congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months
- •immobility casts or splints within the last 6 months for tennis elbow
- •co-existing elbow diagnosis (i.e. osteoarthritis or instability)
- •pregnant women, women trying to get pregnant, or breastfeeding women
- •under the age of 18 or over the age of 65
研究组 & 干预措施
Corticosteroid Injections
Patients will receive 1 cc Kenalong 10 mg injection to the site every 6 weeks until clinical symptoms have resolved. They will also receive an anesthetic of 1cc 1% lidocaine in conjunction with the corticosteroid injection.
干预措施: Corticosteroid Injections (Drug)
Prolotherapy
Participants receive 1cc 50% Dextrose and 1 cc Sodium Morrhuate to the site every 6 weeks until symptoms resolve. These participants will also receive an anesthetic of 1cc 1% lidocaine.
干预措施: Prolotherapy (Drug)
Placebo
Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
干预措施: Placebo Injection (Drug)
Physical Therapy
Participants will be prescribed NSAIDS (Diclofenac 75 mg BID) for 2 weeks. Participants will attend therapy for muscle stretches, soft tissue mobilization, and gradual strengthening.
干预措施: Physical Therapy (Behavioral)
结局指标
主要结局
Symptom severity in post-intervention assessments
时间窗: 12 months
Symptom Severity in pre intervention assessments
时间窗: 12 months
次要结局
- Functional status score pre-intervention(12 months)
- Functional status score severity- post intervention(12 months)