The NOrwegian Tennis Elbow (NOTE) Study
Condition: Lateral Epicondylitis; Tennis Elbow; Tendinopathy, Elbow
MeSH terms: Tendinopathy; Tennis Elbow; Elbow Tendinopathy
Study type: Interventional

Summary: 
      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: 
      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.

        1. 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.

        2. 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.

        3. 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.
    

Intervention name(s): Heavy Slow Exercises; Extracorporeal Shock wave therapy; Information and advice
Intervention type(s): Other; Device; Other
Intervention description(s): 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.; 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; 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.
Other intervention name(s): HSR; rESWT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a prospective randomised controlled trial, feasibility trial.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Extracorporeal shock wave therapy; Heavy slow resistance exercise; Strength exercises