Clinical trial NCT04803825: The NOrwegian Tennis Elbow (NOTE) Study
Official title: The Feasibility of Heavy-slow Resistance Training, Radial Extracorporeal Shockwave Therapy (rESWT) and Information and Advice. The NOrwegian Tennis Elbow (NOTE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Tennis Elbow
Tendinopathy, Elbow
Keywords: Extracorporeal shock wave therapy
Heavy slow resistance exercise
Strength exercises
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective randomised controlled trial, feasibility trial.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The process of recruitment
timeFrame: 2 year
measure: Intervention adherence (appointments)
timeFrame: 3 months
measure: Intervention adherence (training sessions)
timeFrame: 3 months
measure: Intervention acceptability and understandability
timeFrame: 3 months
measure: Retention and completeness of patient-reported outcome measures
timeFrame: 6 months
Secondary outcomes:
measure: The Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 6 months
measure: Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH)
timeFrame: 6 months
measure: The 5-level EQ-5D (EQ-5D-5L)
timeFrame: 6 months
measure: The 5-level EQ-5D (EQ-5D-5L) VAS (EQ VAS)
timeFrame: 6 months
measure: Pain free grip strength
timeFrame: 3 months
measure: Maximum grip strength
timeFrame: 3 months
measure: Maximum grip strength pain
timeFrame: 3 months
measure: Global improvement
timeFrame: 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Håkon Sveinall, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
citation: Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
citation: Macdermid J. Update: The Patient-rated Forearm Evaluation Questionnaire is now the Patient-rated Tennis Elbow Evaluation. J Hand Ther. 2005 Oct-Dec;18(4):407-10. doi: 10.1197/j.jht.2005.07.002. No abstract available.
citation: Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016 Dec;50(23):1428-1437. doi: 10.1136/bjsports-2016-096651. Epub 2016 Oct 5.
citation: Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.