AzTrials
AzTrials

Lateral EpicondylitisBFRNCT05919914

The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.

A study testing Exercise with Blood Flow Restriction (BFR) and Exercise without Blood Flow Restriction (BFR) in people with Lateral Epicondylitis, run by University of West Attica at 2 sites in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

A randomized cross-over trial comparing the immediate effects of a wrist extensor exercise with and without blood flow restriction (BFR) on pain perception in patients with lateral elbow tendinopathy (LET). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lateral Epicondylitis
What is being tested?
Exercise with Blood Flow Restriction (BFR) and Exercise without Blood Flow Restriction (BFR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesGreece
Study dates
29 Apr 2023to May 2024
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men and women diagnosed with Lateral Elbow Tendinopathy (LET)
  • Symptoms for over 2 weeks
  • Pain provoked by palpation on the lateral epicondyle
  • Positive: Cohen's test, Maudsley test, Mill's test
  • decrease in pain grip strength >5% in elbow extension compared to flexion

Who cannot join

  • Shoulder tendinopathy
  • Cervical radiculopathy
  • Rheumatoid arthritis
  • Neurological deficit
  • Radial nerve entrapment
  • Past treatment for the elbow before entering the study
Show all 18Show fewer
  • Professional athletes
  • Lateral elbow tendinopathy of the same side in the last 3 years
  • Serious cardiovascular diseases
  • Venous deficiency
  • History of heart surgery
  • Cancer history
  • Breast surgery
  • Orthopaedic surgeries during the last 6 months
  • Thrombosis
  • Body mass Index ≥ 30
  • Crohn syndrome
  • Family or personal history of pulmonary embolism

Trial locations and contacts

2 sites in 1 country.

Greece2 sites

  • University of West Attica

    Aigáleo, Attica, 12243

  • University of West Attica

    Aigáleo, Attica, 15271

Other trials in Greece

About this study

Official title: The Immediate Effects of a Wrist Extensors Exercise With Blood Flow Restriction BFR in Lateral Elbow Tendinopathy. A Randomized Controlled Trial.

A randomized cross-over trial comparing the immediate effects of a wrist extensor exercise with and without blood flow restriction (BFR) on pain perception in patients with lateral elbow tendinopathy (LET).

Read the detailed description

Patients with LET will participate in the study performing an exercise with and without blood flow restriction (BFR) in a randomized order (two occasions). A target of 20 patients for enrollment has been set for 80% power, p<0.05 (Effect size= 1). Two interventions will be used lasting 40 minutes each.

Intervention: A wrist extension exercise (concentric-eccentric) with Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (<2/10 in numerical pain rating scale).

Control Group: A wrist extension exercise (concentric-eccentric) without Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (<2/10 in numerical pain rating scale).

Primary outcomes: pressure pain thresholds lateral epicondyle, cervical spine and tibialis anterior (bilateral).

Secondary outcome: pain free grip strength

Being tested
Exercise with Blood Flow Restriction (BFR), Exercise without Blood Flow Restriction (BFR)
Keywords
tennis elbow, pain threshold, elbow tendinopathy, BFR, hypoalgesia
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.

  • Exercise with Blood Flow Restriction (BFR)Other

    Wrist extensor exercise (concentric - eccentric) with BFR. BFR involves the reduction of blood flow to working skeletal muscle by applying a flexible cuff to the most proximal portions of a person's arms or legs that results in decreased arterial flow to the exercising muscle and occluded venous return back to the central circulation.

  • Exercise without Blood Flow Restriction (BFR)Other

    Wrist extensor exercise (concentric - eccentric)

Study groups in NCT05919914
Study groupRoleWhat they receive
Wrist extensor exercise with Blood Flow RestrictionExperimentalBlood flow restriction training. Patients will execute a wrist extension exercise on standing position with the elbow extended. The load (dumbbells) will be set according to a pain monitoring approach ( exercise should not provoke pain >2/10) during wrist extension. Load is increased by 0.5 to 1kg. We will allow a 30 sec break. The session starts by calculating the arterial occlusion pressure in the standard anatomical position. Participants rest in the standing position for 3-5 minutes before measurement to ensure restoration of blood flow circulation and a cuff is placed in the most proximal part of their dominant upper-limb. BFR application is conducted by using an automatic personalized tourniquet system (Mad-Up Pro, France). An 40% occlusion pressure is set and subjects perform 4 sets of wrist extension (30-15-15-15 reps).
Receives: Other: Exercise with Blood Flow Restriction (BFR)
Wrist extensor exercise without Blood Flow RestrictionActive comparatorPatients will execute a wrist extension exercise on standing position with the elbow extended. The load (dumbbells) will be set according to a pain monitoring approach ( exercise should not provoke pain >2/10) during wrist extension. Load is increased by 0.5 to 1kg. We will allow a 30 sec break.
Receives: Other: Exercise without Blood Flow Restriction (BFR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure pain threshold

    Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using bilateral sites on lateral epicondyle, cervical spine and tibialis anterior. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group.

    Measured: Baseline and 30 minutes

Secondary outcomes (1)

  1. Pain free grip strength (PFGS)

    'Jamar' hand dynamometer was used, calculating the mean value (kilograms) of 3 efforts, separated by 30-second rest intervals with participants lying in supine position and the elbow fully extended

    Measured: Baseline and 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start29 Apr 2023
  3. Primary completionApr 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

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
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05919914
Sponsor's protocol ID
11168 - 06/02/2023
Acronym
BFR
Status last verified
Jul 2023
First submitted
12 Jun 2023
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13.

    PubMed 36099170

  • Karanasios S, Lignos I, Gioftsos G. Wrist Extensor Training With Blood Flow Restriction for the Management of Lateral Elbow Tendinopathy: A Case Report. Cureus. 2023 Feb 25;15(2):e35468. doi: 10.7759/cureus.35468. eCollection 2023 Feb.

    PubMed 36999107

  • Peterson M, Butler S, Eriksson M, Svardsudd K. A randomized controlled trial of eccentric vs. concentric graded exercise in chronic tennis elbow (lateral elbow tendinopathy). Clin Rehabil. 2014 Sep;28(9):862-72. doi: 10.1177/0269215514527595. Epub 2014 Mar 14.

    PubMed 24634444

  • Yoon SY, Kim YW, Shin IS, Kang S, Moon HI, Lee SC. The Beneficial Effects of Eccentric Exercise in the Management of Lateral Elbow Tendinopathy: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Sep 1;10(17):3968. doi: 10.3390/jcm10173968.

    PubMed 34501416

  • Bisset L, Coombes B, Vicenzino B. Tennis elbow. BMJ Clin Evid. 2011 Jun 27;2011:1117.

    PubMed 21708051

  • Lee JH, Kim TH, Lim KB. Effects of eccentric control exercise for wrist extensor and shoulder stabilization exercise on the pain and functions of tennis elbow. J Phys Ther Sci. 2018 Apr;30(4):590-594. doi: 10.1589/jpts.30.590. Epub 2018 Apr 20.

    PubMed 29706713

  • Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.

    PubMed 26381484

Questions about this trial

What is this clinical trial studying?

A study testing Exercise with Blood Flow Restriction (BFR) and Exercise without Blood Flow Restriction (BFR) in people with Lateral Epicondylitis, run by University of West Attica at 2 sites in Greece.

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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. 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?

Results are not available in the source record.

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?

Pressure pain threshold (time frame: Baseline and 30 minutes). 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 NCT05919914, which also lists 7 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 10 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in