The Feasibility of Heavy-slow Resistance Training, Radial Extracorporeal Shockwave Therapy (rESWT) and Information and Advice. The NOrwegian Tennis Elbow (NOTE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The process of recruitment
研究概览
简要总结
Trial Design:
The Norwegian Tennis Elbow (NOTE) study is a single-centre; three-armed, feasibility randomised controlled trial.
Aim:
The primary aim of this study is to pilot the methods proposed to conduct a definite RCT study.
Objectives:
- Measure the process of recruitment.
- Measure intervention adherence and acceptability.
- Measure outcome measure retention rate and completeness. The Patient-Rated Tennis Elbow Evaluation (PRTEE) will be used as the primary outcome measure.
Intervention:
Patients will be randomised to either: 1) Heavy slow resistance training (HSR), 2) Radial extracorporeal shock wave therapy (rESWT) or 3) Information and advice.
Follow-up will be after 3 and 6 months.
详细描述
Background:
Lateral epicondylalgia, also known as tennis elbow, cause functional disability with high costs due to productivity loss, healthcare use and sickness absence. Evidence shows that physiotherapy is the most preferred patient treatment among Norwegian patients. However, the most efficient treatment for chronic tennis elbow is yet to be acknowledged. Exercises are a commonly used modality for tennis elbows. However, contradictory to lower limb tendinopathies, a pragmatic heavy slow resistance (HSR) exercise training protocol for tennis elbow have not yet been investigated. Radial extracorporeal shock wave therapy (rESWT) is another widely used modality and evidence is spares and inconsistent, reviews conclude that more high quality studies are needed.
This feasibility study will provide methodological evidence that will play an important role in the development of future RCT. The project will include 60 patients with lateral epicondylalgia, these patients will be randomised to either: 1) HSR exercises 2) rESWT or 3) information and advice. The randomization sequence is computer-generated with blocks of variable size, which is unknown to the treater and the outcome assessor. A research assistant will supply the trial physiotherapist with allocations to which group. The investigator assessing the outcome measures will be blind to group allocation. Statistical analysis will be conducted on a blinded intention-to-treat basis. Due to the nature of the intervention in the study, blinding of the trial physiotherapist will not be possible.
Tele rehabilitation and welfare technology are rapidly increasing its usability and value. To investigate if tele rehabilitation is suitable for a RCT, the exercise group will be offered voluntary tele rehabilitation as an alternative to physical follow-up.
Aims:
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to fill in the questionnaires (understand oral and written Norwegian)
- •Clinically diagnosed tennis elbow provoked by at least two of: Pain on pressure of the common extensor origin, Pain during power grip, Resisted wrist extension (Tomsen test), Resisted third finger extension (Maudsley´s test), Stretching of the extensors (Mill´s test)
排除标准
- •Patients With significant Language issues (does not understand oral or written Norwegian
- •Contraindications to ESWT (pregnancy, coagulation disturbance, connective tissues disease, epilepsy, use og pacemaker)
- •Suspicion of other serious illness
研究组 & 干预措施
Heavy Slow Exercise
One dedicated physiotherapist will supervise and instruct the exercise program on an individual basis. If the patient doesn't have access to a dumbbell, it will be offered free rental from the physiotherapy ward. Follow-up on the exercises will be scheduled as needed and tele rehabilitation will be offered as an option. Additionally to HSR exercises, participants will be instructed to perform daily stretches of the forearm.
干预措施: Heavy Slow Exercises (Other)
Extracorporeal Shock wave therapy
The patients will receive rESWT (SwissDolodClast/EMS) once a week for three sessions. The treatment will be given by a physiotherapist trained in using rESWT. The rESWT is given on the ECRB tendon insertion area.
干预措施: Extracorporeal Shock wave therapy (Device)
Information and advice
The information and advice group are given a single face-to-face session with a physiotherapist, lasting up to 60 minutes.
干预措施: Information and advice (Other)
结局指标
主要结局
The process of recruitment
时间窗: 2 year
Criteria for success is that \>75 percent of patients should be eligible for randomization, \>90% should be willing to be randomized, recruitment rate should be 3.75 participants per month.
Intervention adherence (training sessions)
时间窗: 3 months
In the HSR group ≥ 30 training sessions should be completed within 12 weeks,
Retention and completeness of patient-reported outcome measures
时间窗: 6 months
The retention of completed patient-reported outcome measures (i.e. PRTEE, Quick DASH, EQ-5D-5L should be \>75 percent.
Intervention adherence (appointments)
时间窗: 3 months
Criteria for success is that 90 percent meets to appointments (Either physically or tele)
Intervention acceptability and understandability
时间窗: 3 months
≥ 10/20 within each group should rate the treatment ≥+3 "acceptable" and ≥ 10/20 within each intervention group should rate the treatment ≥+3 "understandable"
次要结局
- Maximum grip strength(3 months)
- Maximum grip strength pain(3 months)
- Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH)(6 months)
- Global improvement(3 months)
- The 5-level EQ-5D (EQ-5D-5L)(6 months)
- The 5-level EQ-5D (EQ-5D-5L) VAS (EQ VAS)(6 months)
- The Patient-Rated Tennis Elbow Evaluation (PRTEE)(6 months)
- Pain free grip strength(3 months)
研究者
Håkon Sveinall
Principal Investigator
Oslo University Hospital