A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial

NCT07782723 | Recruiting

• 1 other identifier: BA-LE-BFR
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis is a chronic degenerative tendinopathy characterized by pain, tenderness, decreased grip strength, and functional limitations, particularly on the outer part of the elbow. While conservative treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and extracorporeal shock wave therapy (ESWT) are used, surgical methods are considered as alternatives in resistant cases. ESWT reduces pain and inflammation by increasing vascularization in the targeted area and supporting tissue regeneration. Blood flow restriction therapy (BFR), on the other hand, promotes muscle hypertrophy and strength gains through low-intensity exercise. The biochemical effects of both methods increase cellular proliferation and protein synthesis through different mechanisms, thereby supporting tissue healing and functional recovery. However, there are no studies in the literature examining the effects of combining ESWT and BFR in patients with lateral epicondylitis. Therefore, in our study, we aimed to evaluate the effects of the combined application of ESWT and BFR on pain, muscle strength, and functionality in the treatment of lateral epicondylitis. Patients will be divided into two groups and will undergo treatment for a total of 4 weeks, with one session per week. The study group will receive ESWT treatment in combination with blood flow restriction therapy (BFR). The control group will receive only ESWT. In both groups, the intensity of the ESWT treatment will be increased between sessions based on the patient's pain tolerance. Pain levels, grip strength, wrist isometric muscle strength, and upper extremity functional status will be assessed in patients in both the treatment and control groups before and after treatment. The effectiveness of the methods will be statistically analyzed. The findings obtained may contribute to the development of an innovative, evidence-based treatment protocol in the field of physical therapy and rehabilitation, thereby filling a gap in the literature aimed at improving pain management and functional recovery in the treatment of lateral epicondylitis.

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; blood flow restriction; extracorporeal shock wave therapy

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  Pain intensity at rest, during activity, and at night will be assessed using the Visual Analog Scale (VAS).

  Baseline and at the end of 4 weeks

• Grip Strength

  The grip strength will be measured using a Jamar hand dynamometer.

  Baseline and at the end of 4 weeks

• Isometric Muscle Strength

  Wrist isometric flexion and extension muscle strength will be assessed using the Nicholas MMT Hand-Held dynamometer.

  Baseline and at the end of 8 weeks.

• Functional Activity

  Functional activity will be assessed using the DASH (Disability of the Arm, Shoulder, and Hand) questionnaire.

  Baseline and at the end of 4 weeks

Study Arms (2)

Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR

Participants in this group will receive ESWT treatment once a week for 4 weeks for their elbows, which have been diagnosed with lateral epicondylitis.

Other: Extracorporeal Shock Wave Therapy

Extracorporeal Shock Wave Therapy and Blood Flow Restriction Therapy

EXPERIMENTAL

Participants in this group will receive ESWT and BFR treatment once a week for 4 weeks for their elbows, which have been diagnosed with lateral epicondylitis.

Other: Blood Flow Restriction Therapy

Interventions

Blood Flow Restriction Therapy OTHER

For blood flow restriction therapy, the occlusion pressure will be set at 40%-50% of the arterial occlusion pressure. During the 20-minute blood flow restriction therapy session, upper extremity strengthening, stretching, and stabilization exercises will be performed. The weight used in the strengthening exercises will be selected to be 20%-30% of 1 RM. Extracorporeal shock wave therapy will be performed using a Radial ESWT device. The intensity will be increased between sessions based on the patient's pain tolerance. The treatment will be administered once a week for 4 weeks.

Extracorporeal Shock Wave Therapy and Blood Flow Restriction Therapy

Extracorporeal Shock Wave Therapy OTHER

Extracorporeal shock wave therapy will be performed using a Radial ESWT device. The intensity will be increased between sessions based on the patient's pain tolerance. The treatment will be administered once a week for 4 weeks.

Extracorporeal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having been diagnosed with lateral epicondylitis by a specialist physician
• Being between the ages of 18 and 60
• Having a body mass index (BMI) between normal weight (18.5-24.9 kg/m²) and overweight (25.0-29.9 kg/m²)
• Volunteering to participate in the study

You may not qualify if:

• Presence of a different elbow pathology
• Presence of bilateral lateral epicondylitis
• Presence of sensory and motor impairments in the upper extremities
• History of surgery in the elbow region
• History of systemic or metabolic disease
• History of diabetes mellitus
• History of hematological disease
• History of cardiac disease, heart failure, or coronary artery disease
• History of hypertension
• Malignancy
• History of peripheral vascular disease (presence of varicose veins/history, history of deep vein thrombosis, presence of lymphedema)
• Coagulation disorder
• Use of anticoagulants
• History of pulmonary disease
• History of pulmonary embolism

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Gülhane Training and Research Hospital, Clinic of Sports Medicine

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (15)

• Kinandana, G. P., Anak Ayu Nyoman Trisna Narta Dewi, I Made Niko Winaya, Ni Komang Ayu Juni Antari, Ari Wibawa, & I Putu Gde Surya Adhitya; The Efficacy of Blood Flow Restriction Training for Grip Strength and Disability in Lateral Epicondylitis; Bali Medical Journal; 2023; 12(1); 410-415.

  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

• Scott BR, Slattery KM, Sculley DV, Dascombe BJ. Hypoxia and resistance exercise: a comparison of localized and systemic methods. Sports Med. 2014 Aug;44(8):1037-54. doi: 10.1007/s40279-014-0177-7.

  PMID: 24715613 BACKGROUND

• Gorgey AS, Timmons MK, Dolbow DR, Bengel J, Fugate-Laus KC, Michener LA, Gater DR. Electrical stimulation and blood flow restriction increase wrist extensor cross-sectional area and flow meditated dilatation following spinal cord injury. Eur J Appl Physiol. 2016 Jun;116(6):1231-44. doi: 10.1007/s00421-016-3385-z. Epub 2016 May 7.

  PMID: 27155846 BACKGROUND

• Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

  PMID: 31156448 BACKGROUND

• Pettrone FA, McCall BR. Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis. J Bone Joint Surg Am. 2005 Jun;87(6):1297-304. doi: 10.2106/JBJS.C.01356.

  PMID: 15930540 BACKGROUND

• Murat S, Dogruoz Karatekin B, Zengin M. Clinical and Sonographic Evaluation of the Effectiveness of Extracorporeal Shock Wave Therapy in Patients with Lateral Epicondylitis. Medeni Med J. 2024 Jun 28;39(2):109-116. doi: 10.4274/MMJ.galenos.2024.60308.

  PMID: 38940482 BACKGROUND

• Zhang D, Kearney CJ, Cheriyan T, Schmid TM, Spector M. Extracorporeal shockwave-induced expression of lubricin in tendons and septa. Cell Tissue Res. 2011 Nov;346(2):255-62. doi: 10.1007/s00441-011-1258-7. Epub 2011 Oct 19.

  PMID: 22009294 BACKGROUND

• Yoon SY, Kim YW, Shin IS, Moon HI, Lee SC. Does the Type of Extracorporeal Shock Therapy Influence Treatment Effectiveness in Lateral Epicondylitis? A Systematic Review and Meta-analysis. Clin Orthop Relat Res. 2020 Oct;478(10):2324-2339. doi: 10.1097/CORR.0000000000001246.

  PMID: 32332245 BACKGROUND

• Lai WC, Erickson BJ, Mlynarek RA, Wang D. Chronic lateral epicondylitis: challenges and solutions. Open Access J Sports Med. 2018 Oct 30;9:243-251. doi: 10.2147/OAJSM.S160974. eCollection 2018.

  PMID: 30464656 BACKGROUND

• G MK, S N, K K, S R, S S, V R, Kirthika S V, Raman K, Sankaranarayanan S, C P. Efficacy of Plyometric and TheraBand FlexBar Exercises in Tennis Elbow Patients: A Comparative Study. Cureus. 2024 Jun 2;16(6):e61525. doi: 10.7759/cureus.61525. eCollection 2024 Jun.

  PMID: 38957235 BACKGROUND

• Shiri R, Viikari-Juntura E. Lateral and medial epicondylitis: role of occupational factors. Best Pract Res Clin Rheumatol. 2011 Feb;25(1):43-57. doi: 10.1016/j.berh.2011.01.013.

  PMID: 21663849 BACKGROUND

• Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. doi: 10.1093/aje/kwj325. Epub 2006 Sep 12.

  PMID: 16968862 BACKGROUND

• Zhang L, Zhang X, Pang L, Wang Z, Jiang J. Extracorporeal Shock Wave Therapy Versus Local Corticosteroid Injection for Chronic Lateral Epicondylitis: A Systematic Review with Meta-Analysis of Randomized Controlled Trials. Orthop Surg. 2024 Nov;16(11):2598-2607. doi: 10.1111/os.14212. Epub 2024 Aug 28.

  PMID: 39198038 BACKGROUND

• Kraushaar BS, Nirschl RP. Tendinosis of the elbow (tennis elbow). Clinical features and findings of histological, immunohistochemical, and electron microscopy studies. J Bone Joint Surg Am. 1999 Feb;81(2):259-78. No abstract available.

  PMID: 10073590 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Blood Flow Restriction Therapy; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: The study will be conducted as a randomized controlled trial involving patients aged 18-60 who have been diagnosed with lateral epicondylitis. The study group will receive ESWT treatment combined with blood flow restriction therapy, while the control group will receive ESWT alone. Both groups will undergo treatment once a week for 4 weeks. Assessments of rest, activity, and nighttime pain levels, bilateral grip strength, bilateral wrist extension and flexion isometric muscle strength, and upper extremity functional status will be performed before and after treatment.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: April 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)