NCT05919914

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 12, 2023

Last Update Submit

July 6, 2023

Conditions

Lateral Epicondylitis

Keywords

tennis elbowpain thresholdelbow tendinopathyBFRhypoalgesia

Outcome Measures

Primary Outcomes (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.

    Baseline and 30 minutes

Secondary Outcomes (1)

  • Pain free grip strength (PFGS)

    Baseline and 30 minutes

Study Arms (2)

Wrist extensor exercise with Blood Flow Restriction

EXPERIMENTAL

Blood 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).

Other: Exercise with Blood Flow Restriction (BFR)

Wrist extensor exercise without Blood Flow Restriction

ACTIVE COMPARATOR

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.

Other: Exercise without Blood Flow Restriction (BFR)

Interventions

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.

Wrist extensor exercise with Blood Flow Restriction
Exercise without Blood Flow Restriction (BFR)OTHER

Wrist extensor exercise (concentric - eccentric)

Wrist extensor exercise without Blood Flow Restriction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Shoulder tendinopathy
  • Cervical radiculopathy
  • Rheumatoid arthritis
  • Neurological deficit
  • Radial nerve entrapment
  • Past treatment for the elbow before entering the study
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of West Attica

Aigáleo, Attica, 12243, Greece

Location

University of West Attica

Aigáleo, Attica, 15271, Greece

Location

Related Publications (7)

  • 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.

    PMID: 36099170BACKGROUND

  • 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.

    PMID: 36999107BACKGROUND

  • 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.

    PMID: 24634444BACKGROUND

  • 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.

    PMID: 34501416BACKGROUND

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

    PMID: 21708051BACKGROUND

  • 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.

    PMID: 29706713BACKGROUND

  • 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.

    PMID: 26381484BACKGROUND

MeSH Terms

Conditions

Tennis ElbowElbow Tendinopathy

Interventions

Exercise

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • George Gioftsos, PhD

    Physiotherapy Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 26, 2023

Study Start

April 29, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(2)