Condition category
Musculoskeletal Diseases
Date applied
24/10/2019
Date assigned
20/01/2020
Last edited
30/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Patients with lateral elbow epicondylitis (or tennis elbow) are treated with physiotherapy. The use of specific exercises is a common and effective intervention for the safest and fastest recovery. The use of additional specific exercises with blood flow restriction at the extremities has been suggested to deliver significant results, faster and with less pain. However, it is not yet known whether they are more effective in lateral elbow tendinopathy. Therefore, the aim of this study is to assess the effectiveness of these exercises in patients with external elbow tendinopathy.

Who can participate?
Patients aged 18-50 with external elbow tendinopathy lasting for more than two weeks

What does the study involve?
Patients are divided into two groups. One group does exercises with blood flow restriction and the other without restriction. Sessions are held twice a week and the process takes a total of 6 weeks. Participants undergo an additional re-evaluation visit after 12 weeks.

What are the possible benefits and risks of participating?
Although there is no additional benefit to participation, this study aims to significantly improve the care of patients with lateral elbow tendinopathy in the immediate future. Participation is voluntary and non-participation will not affect the quality of the treatment services received. Participants are free to leave the study at any time without having to explain the reasons. Contraindications and risks to participation are minimal and common to any form of active treatment. Applying the exercises can rarely cause local reactions such as muscle discomfort, tenderness or numbness for 24-48 hours due to pressure in the area. The feeling is like the muscle soreness one experiences when returning to exercise after a long absence. Personal data collected will be kept strictly confidential by the principal investigator. Research staff and therapists will only know the necessary details. The information will be encrypted so that it cannot be identified.

Where is the study run from?
University of West Attica (Greece)

When is the study starting and how long is it expected to run for?
March 2019 to March 2021

Who is funding the study?
University of West Attica (Greece)

Who is the main contact?
1. Stefanos Karanasios PhD Cand, MSc, PT
skaranasios@uniwa.gr
2. Prof. Georgios Gioftsos
gioftsos@uniwa.gr

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stefanos Karanasios

ORCID ID

Contact details

44 Th. Diligianni Street
Kifisia
14562
Greece
+30 (0)6947686583
physio.manual@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

20191023SK

Study information

Scientific title

The effects of low load resistance training with blood flow restriction in patients with lateral elbow tendinopathy: a randomized controlled trial

Acronym

Blood Flow Restriction (BFR), Lateral Elbow Tendinopathy (LET)

Study hypothesis

Low load resistance exercises with blood flow restriction are more effective in increasing strength, reducing pain and improving function compared to usual exercises in patients with lateral elbow tendinopathy.

Ethics approval

Approved 09/06/2020, Research Ethics Committee University Of West Attica (UNIWA, Egaleo Park Campus, Agiou Spiridonos 28, 12243 Egaleo, Athens, Greece; +30 (0)2105387294; ethics@uniwa.gr), ref: 36898 / 03-06-2020

Study design

Single-center triple-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Lateral elbow tendinopathy (tennis elbow)

Intervention

Participants will be randomized with an appropriate software https://www.randomizer.org/ to either a blood flow restriction exercise programme or a placebo blood flow restriction exercise programme. A concealed allocation will be applied. Assessor, therapists and patients will be blinded.

Both groups of patients will be treated with a usual exercise programme in lateral elbow tendinopathy. One group will use blood flow restriction and the other group placebo blood flow restriction (cuffs without air inflated). The exercise programmes will be held in physiotherapy sessions (twice a week) for 6 weeks. Also, all patients will be treated with soft tissue massage and the same appropriate advice and a home exercise programme.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. Pain-free grip strength: the mean value (kg) of three efforts presented as a ratio of the maximum grip strength of the unaffected side will be included A Jamar hand dynamometer is used. Measured at baseline, 6 and 12 weeks follow-up
2. Pain and functional disability measured using the patient-rated tennis elbow (PRTEE) questionnaire at baseline, 6 weeks and 12 weeks follow-up.
3. Pain measured using the visual analogue score (NRPS) at baseline, 6 and 12 weeks

Secondary outcome measures

1. Tendon thickness, neovascularity, presence of spurs, calcification and/or tears in the common extensor tendon (lateral epicondyle) measured using diagnostic ultrasound imaging at baseline, 6 and 12 weeks follow-up
2. Isometric strength of elbow flexors and extensors measured using Bio Fet force evaluation system (mean of three efforts of the maximum isometric contraction) at baseline, 6 and 12 weeks follow-up
3. Self-perceived recovery measured using 6-point Global Rating Of Change (GROC) scale at 6 and 12 weeks follow-up

Overall trial start date

01/03/2019

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 30/07/2020:
1. Men and women 18-50 years old diagnosed with LET
2. Symptoms for over 2 weeks
3. Pain provoked by palpation on the lateral epicondyle
4. Positive: Cohen's test, Maudsley test, Mill's test
5. A decrease in pain grip strength >5% in elbow extension compared to flexion

Previous inclusion criteria:
1. Men and women 18-50 years old diagnosed with LET
2. Symptoms for over 2 weeks
3. Pain provoked by palpation on the lateral epicondyle
4. Positive: Cohen's test, Maudsley test, Mill's test
5. Pain grip strength ratio >5% on unhealthy side compared to the healthy one

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Shoulder tendinopathy
2. Cervical radiculopathy
3. Rheumatoid arthritis
4. Neurological deficit
5. Radial nerve entrapment
6. Past treatment for the elbow before entering the study
7. Professional athletes
8. Lateral elbow tendinopathy of the same side in the last 3 years
9. Serious cardiovascular diseases
10. Venous deficiency
11. History of heart surgery
12. Cancer history
13. Breast surgery
14. Orthopaedic surgeries during the last 6 months
15. Thrombosis
16. Body mass Index ≥ 30
17. Crohn syndrome
18. Family or personal history of pulmonary embolism

Recruitment start date

01/02/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Greece

Trial participating centre

Physio Kifisia
44 Th Diligianni Street
Kifisia
14562
Greece

Sponsor information

Organisation

University of West Attica

Sponsor details

Agiou Spiridonos 28
Egaleo
Athens
12243
Greece
+30 (0)210 5387485
physio@uniwa.gr

Sponsor type

University/education

Website

https://www.uniwa.gr/en/home-page/

Funders

Funder type

University/education

Funder name

University of West Attica

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A study protocol is not currently available online. At the end of data analysis, the results of the study will be published in international congress and electronic scientific journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Stefanos Karanasios (physio.manual@gmail.com). Type of data: row data of primary and secondary outcome measures. Availability: from 31/03/2021. Access criteria: systematic reviews and meta-analysis, quantitative synthesis for studies in the same scope of interest, peer review reasons. Mechanisms: upon request. Consent from participants is obtained according to GDPR data protection.

Intention to publish date

24/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/07/2020: Inclusion criteria updated. 27/07/2020: Ethics approval details added. 30/03/2020: Uploaded protocol and statistical analysis plan 30 March 2020 (not peer-reviewed). 27/03/2020: Uploaded protocol (not peer reviewed). 20/01/2020: Trial's existence confirmed by the admin office and the President of the Physiotherapy Department of the University of West Attica.