Finnish Tennis Elbow Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 12
- 主要终点
- Oxford Elbow Score
研究概览
简要总结
The study aims to investigate the natural course and the results of operative treatment of chronic tennis elbow (TE). Chronic is defined as symptoms having lasted for more than a year. The investigators will also study the effect of pain catastrophising on the subjective outcome, the patient acceptable symptomatic state and the response shift phenomenon in TE. The study will also ascertain the feasibility of a multi-center randomised, controlled trial (RCT), and test and refine the co-operation and interaction of the planned RCT centers.
详细描述
Objectives:
- To study the natural course of tennis elbow/spontaneous recovery of chronic (lasting for over 12 months) tennis elbow and the results of surgery in a pragmatic setting.
- To investigate the patients' expectations of the treatment, and define the patient acceptable symptomatic state, or PASS, in tennis elbow.
- To investigate the effect of pain behaviour on treatment results and PASS.
- To delineate the existence of a potential "response shift" -phenomenon in patients with a tennis elbow.
- To determine the feasibility of a prospective, placebo-controlled, randomised trial by finding out the actual number of patients in each center and those that may be suitable for the FINITE-RCT. The investigators will also test the functioning and response of the planned outcome measures in this environment and for this purpose.
Study setting The study is carried out as a prospective open-label multi-center cohort study.
The study was originally planned with a follow-up up to 10 years, but the cost-benefit of the long term follow-up was evaluated after the completion of one year data collection, and the decision was made to shorten the follow-up to include two year data, but no further follow-ups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed tennis elbow defined as: Pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and during resisted extension of the wrist or when making a fist with the elbow joint straight.
- •Duration of symptoms over 10 months
- •Age between 35 and 60 years
- •Ability to fill in Finnish questionnaires
- •Written informed consent
排除标准
- •Earlier fracture or dislocation in the elbow joint area
- •Earlier surgical treatment of the same elbow joint
- •Congenital deformity in the elbow
- •Systemic muscle, tendon, nerve or joint disease
- •Other problems causing pain the elbow joint:
- •Pain in the medial epicondyle of the elbow
- •Pain in the biceps muscle tendon
- •Painful snapping or crepitus of elbow joint
- •Instability of elbow joint (table top, posterolateral drawer test)
- •A passive movement limitation of more than 10 degrees in the elbow joint
- •Abnormal finding in an elbow joint X-ray. An elbow joint X-ray is a routine examination of elbow symptoms.
结局指标
主要结局
Oxford Elbow Score
时间窗: 6 months
Oxford Elbow Score (OES) is a three-dimensional questionnaire consisting of 12 multiple-choice questions answered by the patient. OES has been validated for patients with surgically treated elbow problems. OES is the most robust elbow-specific PROM available currently.
Global improvement
时间窗: 6 months
A six-point Likert scale (much worse - worse - no change - better - much better - complete recovery) will be used and the patient is asked how the elbow symptoms are compared to the situation at the time of the initial visit and inclusion to the study.
次要结局
- Time off work(up to 2 years)
- Complications and adverse effects(up to 2 years)
- Relapses(up to 2 years)
- Satisfaction with the treatment process(up to 2 years)
- Success rate(up to 2 years)
- Global improvement(up to 2 years)
- Oxford Elbow Score(up to 2 years)
- QuickDASH(up to 2 years)
研究者
Tuomas Lahdeoja
MD, specialist in orthopaedics and traumatology
University of Helsinki