The NOrwegian Tennis Elbow (NOTE) Study

NCT04803825 | Completed DMC

• 1 other identifier: 109547
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis; Tennis Elbow; Tendinopathy, Elbow

Keywords

Extracorporeal shock wave therapy; Heavy slow resistance exercise; Strength exercises

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• The Patient-Rated Tennis Elbow Evaluation (PRTEE)

  6 months

• Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH)

  6 months

• The 5-level EQ-5D (EQ-5D-5L)

  6 months

• The 5-level EQ-5D (EQ-5D-5L) VAS (EQ VAS)

  6 months

• Pain free grip strength

  3 months

Study Arms (3)

Heavy Slow Exercise

EXPERIMENTAL

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

Extracorporeal Shock wave therapy

ACTIVE COMPARATOR

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

Information and advice

ACTIVE COMPARATOR

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

Interventions

Heavy Slow Exercises OTHER

* 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.

Also known as: HSR

Heavy Slow Exercise

Extracorporeal Shock wave therapy DEVICE

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

Also known as: rESWT

Extracorporeal Shock wave therapy

Information and advice OTHER

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.

Information and advice

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

Related Publications (7)

• 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.

  PMID: 27777223 BACKGROUND

• 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.

  PMID: 15866967 BACKGROUND

• 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.

  PMID: 16271687 BACKGROUND

• 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.

  PMID: 27707738 BACKGROUND

• 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.

  PMID: 20169472 BACKGROUND

• 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.

  PMID: 21479777 BACKGROUND

• Sveinall H, Brox JI, Engebretsen KB, Hoksrud AF, Roe C, Johnsen MB. Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial. BMJ Open. 2024 Dec 20;14(12):e085916. doi: 10.1136/bmjopen-2024-085916.

  PMID: 39806585 DERIVED

MeSH Terms

Conditions

Tennis Elbow; Elbow Tendinopathy

Interventions

Extracorporeal Shockwave Therapy; Counseling

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Håkon Sveinall, PT

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is a prospective randomised controlled trial, feasibility trial.

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 18, 2021
• Study Start: August 23, 2021
• Primary Completion: September 13, 2023
• Study Completion: December 20, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Researches who provide a methodologically sound proposal

Locations

NO (1)