The NOrwegian Tennis Elbow (NOTE) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: The objectives that will be evaluate is; 1) the process of recruitment, 2) intervention adherence and acceptability and 3) the outcome measures. The process of recruitment will be measured by descriptive statistics from the enrolment. If participants redraw after baseline testing or are unwilling to be randomized, the participant will be asked to describe the reason. To measure adherence to the intervention, participants will be asked to fil out an exercise diary which will be controlled at follow up consultations and collected at 3 months. Usage of tele rehabilitation and percentage of participants meeting to their appointments will be measured with descriptive statistics after 3 months. The acceptability and understanding of the intervention will be measure by a -9/+9 likert scale for acceptability of treatment the second session after randomization and at 3 months. The retention rate and completeness of data of the primary and secondary outcome measures for a future full power RCT will be measured with explorative outcomes. Statistical plan: The analysis will focus on descriptive statistics with confidence intervals for the variables obtained. The characteristics of the patients will be presented as means with SDs, as medians with IQR or as counts with percentages. Being a feasibility study, our main aim is to describe the study sample of patients with tennis elbow and to assess our ability to collect data. Hence, the investigators will not perform any imputation of missing data. Change in the main outcome from baseline to follow-up (3 and 6 months) will be analysed using generalised linear mixed models. There will be performed studies evaluating the validity, reliability, interpretability and responsiveness of the The Patient-Rated Tennis Elbow Evaluation, maximum grip strength and pain free grip strength. To achieve adequate power for the evaluation of the psychometric properties of the outcome measures. 40 more tennis elbow participants receiving treatement as usal from our clinic will be added to these analysis, in addion to the 60 participants in the RCT. Included participants will have an ultrasound examination of their elbow by a trained doctor at baseline.

Official Title
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The Feasibility of Heavy-slow Resistance Training, Radial Extracorporeal Shockwave Therapy (rESWT) and Information and Advice. The NOrwegian Tennis Elbow (NOTE) Study

Conditions
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Lateral Epicondylitis, Tennis Elbow, Tendinopathy, Elbow

Intervention / Treatment
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* Other: Heavy Slow Exercises
* Device: Extracorporeal Shock wave therapy
* Other: Information and advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a prospective randomised controlled trial, feasibility trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heavy Slow Exercise<br>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. | Other: Heavy Slow Exercises<br>* Load magnitude: A dumbbell as heavy as possible within the given repetitions and sets. Number of repetitions: week 1: 15 reps, Week 2-3: 12 reps, Week 4-5: 10 reps, Week 6-8: 8 reps, Week 9-12: 6 reps Number of sets: 3 Rest between sets: 2 - 3 min. Number of exercise interventions: 2 Duration of experimental period: 12 weeks Fractional and temporal distribution of the contraction modes per repetition and duration of one repetition: 3s concentric, 2s isometric: while change concentric/eccentric phase, 3s eccentric. Rest in-between repetitions: No Range of motion: Full range of motion Intervention frequency: 3 times a week, with minimum 48 h recovery time in-between.<br>* Other names: HSR;|
| Active Comparator: Extracorporeal Shock wave therapy<br>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. | Device: Extracorporeal Shock wave therapy<br>* Two thousand impulses of shock waves are applied to the painful tendon, with a pressure between 1.5 and 3.0 bar (depending on what the patient tolerates). We use a power hand piece that provides energy of 0.01-0.35 mJ/mm2<br>* Other names: rESWT;|
| Active Comparator: Information and advice<br>The information and advice group are given a single face-to-face session with a physiotherapist, lasting up to 60 minutes. | Other: Information and advice<br>* Information and advice are based on assessment and will comprise the standardized oral and written information. Participants will be educated regarding pain during and after activities and encouraged to be physically active. With only one session, there is great reliance on self-management. Thus, information and advice are made available through a handout.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The process of recruitment | 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. | 2 year | 
| Intervention adherence (appointments) | Criteria for success is that 90 percent meets to appointments (Either physically or tele) | 3 months | 
| Intervention adherence (training sessions) | In the HSR group ≥ 30 training sessions should be completed within 12 weeks, | 3 months | 
| Intervention acceptability and understandability | ≥ 10/20 within each group should rate the treatment ≥+3 acceptable and ≥ 10/20 within each intervention group should rate the treatment ≥+3 understandable | 3 months | 
| Retention and completeness of patient-reported outcome measures | The retention of completed patient-reported outcome measures (i.e. PRTEE, Quick DASH, EQ-5D-5L should be >75 percent. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient-Rated Tennis Elbow Evaluation (PRTEE) | The Patient-Rated Tennis Elbow Evaluation (PRTEE), formerly known as the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis.The questionnaire is scored from 0 - 100 and a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. Scores from The PRTEE questionaire will also be used calculate sample size in a future RCT. | 6 months | 
| Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH) | The Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH) questionnaire is an 11-item shortened version of the thirty-item DASH outcome measure. It measures physical function and symptoms related to upper-limb musculoskeletal disorders. The questionnaire is scored from 0 - 100 and a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. | 6 months | 
| The 5-level EQ-5D (EQ-5D-5L) | The 5-level EQ-5D (EQ-5D-5L) descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: Level 1: no problems, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1 digit number that expresses the level selected for that dimension, The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A total of 3125 possible health states is defined in this way. For example state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression. | 6 months | 
| The 5-level EQ-5D (EQ-5D-5L) VAS (EQ VAS) | The 5-level EQ-5D VAS (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The EQ VAS is scored from 0 - 100 and a lower score indicate poorer health, higher scores indicate a better health. The EQ VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 6 months | 
| Pain free grip strength | Patients will hold a hand grip dynamometer (Jamar) in a standing position with a fully extended elbow in a neutral pronation/supination. The patient will be instructed to squeeze slowly and stop squeezing at the onset of pain; the values in kg will then be registered. The pain free grip strength is measured three times at the asymptomatic side, with a 20-second rest interval between each measurement and then the procedure is repeated at the symptomatic side. After tested in fully extended position the same procedure will be followed with a 90 degrees elbow flexion, and in a neutral pronation/supination. | 3 months | 
| Maximum grip strength | Patients will hold a hand grip dynamometer (Jamar) in a standing position with a fully extended elbow in a neutral pronation/supination. The patient will be instructed to squeeze with their maximum effort; the values in kg will then be registered. The maximum grip strength is measured three times at the asymptomatic side, with a 20-second rest interval between each measurement and then the procedure is repeated at the symptomatic side. After tested in fully extended position the same procedure will be followed with a 90 degrees elbow flexion, and in a neutral pronation/supination. | 3 months | 
| Maximum grip strength pain | Immediately after each of the 12 squeezes of maximum grip strength the physiotherapist will ask the patient to rate their pain on a 10 - point NRS scale where 0 indicate no pain and 10 the worst imaginable pain. | 3 months | 
| Global improvement | The Global improvement will measure the patients change from baseline. With a scale ranging from -5 to +5, where -5 is maximum worsening 0 is unchanged, and +5 is completely recovered. Patients will also answer whether they experience the change as meaningful. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal shock wave therapy, Heavy slow resistance exercise, Strength exercises