Lateral EpicondylitisNCT04803825
The NOrwegian Tennis Elbow (NOTE) Study
A study testing Heavy Slow Exercises, Extracorporeal Shock wave therapy and Information and advice in people with Lateral Epicondylitis and Tennis Elbow, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow, Tendinopathy, Elbow
- What is being tested?
- Heavy Slow Exercises, Extracorporeal Shock wave therapy and Information and advice
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 23 Aug 2021to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- 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.
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Tendinopathy, Elbow
- Being tested
- Heavy Slow Exercises, Extracorporeal Shock wave therapy, Information and advice
- Keywords
- Extracorporeal shock wave therapy, Heavy slow resistance exercise, Strength exercises
- Medical subject headings
- Tennis Elbow, Elbow Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy Slow ExercisesOther
Also called HSR
- 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.
Extracorporeal Shock wave therapyDevice
Also called rESWT
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 adviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Information and advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Intervention adherence (appointments)
Criteria for success is that 90 percent meets to appointments (Either physically or tele)
Measured: 3 months
Intervention adherence (training sessions)
In the HSR group ≥ 30 training sessions should be completed within 12 weeks,
Measured: 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"
Measured: 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.
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start23 Aug 2021
- Primary completion13 Sep 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a prospective randomised controlled trial, feasibility trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Håkon Sveinall, Oslo University Hospital
- Investigators
- Håkon Sveinall, PT, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803825
- Sponsor's protocol ID
- 109547
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request
Publications
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.
PubMed 27777223Beaton 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.
PubMed 15866967Macdermid 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.
PubMed 16271687Slade 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.
PubMed 27707738Mokkink 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.
PubMed 20169472Herdman 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.
PubMed 21479777Sveinall H, Roe C, Engebretsen KB, Skatteboe S, Pripp AH, Brox JI, Johnsen MB. Patient expectations assessed before randomisation and after the first treatment session, and their associations with pain outcome at 3 months in patients with tennis elbow: a secondary analysis of a randomised controlled feasibility trial in Norwegian secondary care. BMJ Open. 2026 Sep 15;16(9):e122686. doi: 10.1136/bmjopen-2026-122686.
PubMed 42744356Sveinall 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.
PubMed 39806585
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Heavy-slow Resistance Training, Radial Extracorporeal Shockwave Therapy (rESWT) and Information and Advice. The NOrwegian Tennis Elbow (NOTE) Study
- ClinicalTrials.gov ID
- NCT04803825
- Acronym / sponsor ID
- 109547
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Tendinopathy, Elbow
- Keywords
- Extracorporeal shock wave therapy, Heavy slow resistance exercise, Strength exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a prospective randomised controlled trial, feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Heavy Slow Exercise | Experimental | Other: Heavy Slow ExercisesOne 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. |
| Extracorporeal Shock wave therapy | Active comparator | Device: Extracorporeal Shock wave therapyThe 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. |
| Information and advice | Active comparator | Other: Information and adviceThe information and advice group are given a single face-to-face session with a physiotherapist, lasting up to 60 minutes. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heavy Slow ExercisesAlso: HSR* 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. | Other | Heavy Slow Exercise |
| Extracorporeal Shock wave therapyAlso: rESWTTwo 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 | Device | Extracorporeal Shock wave therapy |
| Information and adviceInformation 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 | Information and advice |
Primary outcome
The process of recruitment
Time frame: 2 year
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.
Intervention adherence (appointments)
Time frame: 3 months
Criteria for success is that 90 percent meets to appointments (Either physically or tele)
Intervention adherence (training sessions)
Time frame: 3 months
In the HSR group ≥ 30 training sessions should be completed within 12 weeks,
Intervention acceptability and understandability
Time frame: 3 months
≥ 10/20 within each group should rate the treatment ≥+3 "acceptable" and ≥ 10/20 within each intervention group should rate the treatment ≥+3 "understandable"
Retention and completeness of patient-reported outcome measures
Time frame: 6 months
The retention of completed patient-reported outcome measures (i.e. PRTEE, Quick DASH, EQ-5D-5L should be >75 percent.
8 secondary outcomes
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 6 months
Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH)
Time frame: 6 months
The 5-level EQ-5D (EQ-5D-5L)
Time frame: 6 months
The 5-level EQ-5D (EQ-5D-5L) VAS (EQ VAS)
Time frame: 6 months
Pain free grip strength
Time frame: 3 months
Maximum grip strength
Time frame: 3 months
Maximum grip strength pain
Time frame: 3 months
Global improvement
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 27777223Eldridge 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.
- Background: PubMed 15866967Beaton 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.
- Background: PubMed 16271687Macdermid 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.
- Background: PubMed 27707738Slade 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.
- Background: PubMed 20169472Mokkink 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.
- Background: PubMed 21479777Herdman 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.
- Derived from this study: PubMed 42744356Sveinall H, Roe C, Engebretsen KB, Skatteboe S, Pripp AH, Brox JI, Johnsen MB. Patient expectations assessed before randomisation and after the first treatment session, and their associations with pain outcome at 3 months in patients with tennis elbow: a secondary analysis of a randomised controlled feasibility trial in Norwegian secondary care. BMJ Open. 2026 Sep 15;16(9):e122686. doi: 10.1136/bmjopen-2026-122686.
- Derived from this study: PubMed 39806585Sveinall 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.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håkon Sveinall, PT principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy Slow Exercises, Extracorporeal Shock wave therapy and Information and advice in people with Lateral Epicondylitis and Tennis Elbow, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The process of recruitment (time frame: 2 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803825, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.