Blood flow restriction training in tennis elbow (lateral epicondylitis)
| ISRCTN | ISRCTN10724178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10724178 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 20191023SK |
| Sponsor | University of West Attica |
| Funder | University of West Attica |
- Submission date
- 24/10/2019
- Registration date
- 20/01/2020
- Last edited
- 13/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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 December 2021 (updated 23/03/2021, previously: 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
Contact information
Scientific
44 Th. Diligianni Street
Kifisia
14562
Greece
| Phone | +30 (0)6947686583 |
|---|---|
| physio.manual@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center triple-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effects of low load resistance training with blood flow restriction in patients with lateral elbow tendinopathy: a randomized controlled trial |
| Study acronym | Blood Flow Restriction (BFR), Lateral Elbow Tendinopathy (LET) |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 42 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2020 |
| Date of final enrolment | 30/09/2021 |
Locations
Countries of recruitment
- Greece
Study participating centre
Kifisia
14562
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 27/03/2020 | No | No |
Additional files
- ISRCTN10724178_PROTOCOL.pdf
- Uploaded 27/03/2020
Editorial Notes
13/12/2021: The data sharing statement was updated.
23/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2020 to 30/09/2021.
2. The overall end date was changed from 31/03/2021 to 30/12/2021.
3. The plain English summary was updated to reflect these changes.
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.
