Effectiveness of Low-Load Resistance Training With Blood Flow Restriction in Lateral Epicondylitis

NCT07351942 | Completed

• 1 other identifier: LE-LLRT-BFR-TR-34-SE-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis, commonly known as tennis elbow, is a frequent musculoskeletal condition that causes pain, reduced grip strength, and functional limitations in daily activities. Exercise-based rehabilitation is a key component of treatment; however, the optimal exercise approach remains uncertain. Low-load resistance training combined with blood flow restriction (LLRT-BFR) has emerged as a promising method that may enhance training effects while using lower exercise loads, potentially reducing mechanical stress on the affected tissues while providing benefits comparable to high-load resistance training. The purpose of this study is to evaluate the clinical and ultrasonographic effects of LLRT-BFR in patients with lateral epicondylitis. Adults aged 18-65 years with a recent diagnosis of lateral epicondylitis who meet predefined inclusion and exclusion criteria will be enrolled and randomly assigned to one of two exercise-based treatment groups. Both groups will participate in the same supervised low-load resistance exercise program, while one group will perform the exercises with blood flow restriction and the other group will receive a sham application without meaningful blood flow restriction. Participants will undergo supervised exercise sessions twice weekly for six weeks. Outcomes will be assessed at baseline, on the first day after completion of treatment, and at 4 and 12 weeks during follow-up. The primary outcome will focus on functional status, while secondary outcomes will include pain intensity, pain sensitivity, grip strength, ultrasonographic measurements of tendon and muscle structure, and patient-reported treatment satisfaction. By comparing these two exercise approaches, this study aims to provide evidence regarding the effectiveness and safety of LLRT-BFR and to clarify its potential role in the rehabilitation of patients with lateral epicondylitis.

Conditions

Lateral Epicondylitis

Keywords

Lateral Epicondylitis; Tennis Elbow; Blood Flow Restriction Training; BFR; Low-Load Resistance Training; Exercise Therapy; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Patient-Rated Tennis Elbow Evaluation (PRTEE) Total Score

  The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire is used to assess pain and functional disability related to lateral epicondylitis. The total score ranges from 0 to 100, with higher scores indicating greater pain and functional impairment.

  Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

Secondary Outcomes (7)

• Visual Analog Scale (VAS) Pain Intensity Scores

  Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

• Pressure Pain Threshold

  Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

• Grip Strength

  Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

• Common Extensor Tendon Thickness

  Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

• Cross-Sectional Area of the Extensor Carpi Radialis Brevis and Extensor Digitorum Communis Muscles

  Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

Study Arms (2)

Low-Load Resistance Training with Blood Flow Restriction

EXPERIMENTAL

Participants receive a low-load resistance exercise program performed with a blood flow restriction procedure.

Other: Low-Load Resistance Training with Blood Flow Restriction

Low-Load Resistance Training with Sham Blood Flow Restriction

ACTIVE COMPARATOR

Participants receive the same low-load resistance exercise program performed with a sham blood flow restriction procedure.

Other: Low-Load Resistance Training with Sham Blood Flow Restriction

Interventions

Low-Load Resistance Training with Blood Flow Restriction OTHER

A supervised low-load resistance training program performed with a blood flow restriction procedure applied to the affected upper extremity.

Also known as: BFR Training

Low-Load Resistance Training with Blood Flow Restriction

Low-Load Resistance Training with Sham Blood Flow Restriction OTHER

A supervised low-load resistance training program performed with a sham blood flow restriction procedure applied to the affected upper extremity.

Low-Load Resistance Training with Sham Blood Flow Restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a clinical diagnosis of lateral epicondylitis established by a physician
• Presence of symptoms consistent with lateral epicondylitis for more than 2 weeks and less than 12 weeks
• Adults aged 18 to 65 years
• Visual Analog Scale (VAS) pain score ≥ 3
• Willingness to participate in the study and provision of written informed consent

You may not qualify if:

• History of major trauma to the elbow or surrounding region within the past 1 month
• Receipt of physical therapy for the elbow or surrounding region within the past 1 year
• History of corticosteroid or other injection therapies to the elbow or surrounding region within the past 1 year
• History of fracture involving the elbow or surrounding region
• History of surgery involving the elbow or surrounding region
• Presence of rheumatologic diseases affecting the elbow or surrounding region
• History of peripheral vascular disease
• History of coagulation disorders
• History of severe cardiovascular disease
• History of uncontrolled hypertension
• History of uncontrolled diabetes mellitus
• Clinical findings consistent with cervical radiculopathy causing elbow pain or muscle weakness in the affected upper extremity
• Clinical findings consistent with shoulder pathologies causing elbow pain or muscle weakness in the affected upper extremity
• Restricted range of motion of the elbow joint detected on clinical examination
• History of severe psychiatric disorders

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Istanbul, 34418, Turkey (Türkiye)

Location

Related Publications (4)

• Krogh TP, Fredberg U, Ammitzboll C, Ellingsen T. Clinical Value of Ultrasonographic Assessment in Lateral Epicondylitis Versus Asymptomatic Healthy Controls. Am J Sports Med. 2020 Jul;48(8):1873-1883. doi: 10.1177/0363546520921949. Epub 2020 Jun 2.

  PMID: 32484714 BACKGROUND

• Toprak U, Baskan B, Ustuner E, Oten E, Altin L, Karademir MA, Bodur H. Common extensor tendon thickness measurements at the radiocapitellar region in diagnosis of lateral elbow tendinopathy. Diagn Interv Radiol. 2012 Nov-Dec;18(6):566-70. doi: 10.4261/1305-3825.DIR.5575-12.2. Epub 2012 Apr 13.

  PMID: 22498913 BACKGROUND

• Bechan Vergara I, Puig-Divi A, Amestoy Alonso B, Mila-Villarroel R. Effects of low-load blood flow restriction training in healthy adult tendons: A systematic review and meta-analysis. J Bodyw Mov Ther. 2024 Jul;39:13-23. doi: 10.1016/j.jbmt.2023.11.048. Epub 2023 Dec 3.

  PMID: 38876617 BACKGROUND

• 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: 36099170 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Süleyman Çağlar Tekin, MD

  Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are blinded to group allocation. Exercise sessions are supervised by therapists who are not involved in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants are randomly assigned to one of two parallel groups and receive the same low-load resistance exercise program either with a blood flow restriction procedure or with a sham blood flow restriction procedure throughout the study period.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 20, 2026
• Study Start: July 14, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)