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The NOrwegian Tennis Elbow (NOTE) Study

NCT04803825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-05

No results posted yet for this study

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.

Conditions

  • Lateral Epicondylitis
  • Tennis Elbow
  • Tendinopathy, Elbow

Interventions

OTHER

Heavy Slow Exercises

* 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.

DEVICE

Extracorporeal Shock wave therapy

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

OTHER

Information and advice

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.

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Håkon Sveinall, PT · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2023-09-13
Completion
2023-12-20

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803825 on ClinicalTrials.gov