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Recruiting Not applicable

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

NCT07782723 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-04-03
Last updated
2026-08-24

Condition(s) studied

Lateral Epicondylitis

Investigational drug(s) / intervention(s)

Blood Flow Restriction TherapyExtracorporeal Shock Wave Therapy

Blood Flow Restriction Therapy: 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: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Having been diagnosed with lateral epicondylitis by a specialist physician 2. Being between the ages of 18 and 60 3. Having a body mass index (BMI) between normal weight (18.5-24.9 kg/m²) and overweight (25.0-29.9 kg/m²) 4. Volunteering to participate in the study Exclusion Criteria: 1. Presence of a different elbow pathology 2. Presence of bilateral lateral epicondylitis 3. Presence of sensory and motor impairments in the upper extremities 4. History of surgery in the elbow region 5. History of systemic or metabolic disease 6. History of diabetes mellitus 7. History of hematological disease 8. History of cardiac disease, heart failure, or coronary artery disease 9. History of hypertension 10. Malignancy 11. History of peripheral vascular disease (presence of varicose veins/history, history of deep vein thrombosis, presence of lymphedema) 12. Coagulation disorder 13. Use of anticoagulants 14. History of pulmonary disease 15. History of pulmonary embolism 16. Pregnancy 17. Use of oral contraceptives 18. Patients with a pacemaker 19. History of trauma to the upper extremity within the past 6 months or 1 year

Primary outcome measure(s)

  • Pain Intensity — Baseline and at the end of 4 weeks
    Pain intensity at rest, during activity, and at night will be assessed using the Visual Analog Scale (VAS).
  • Grip Strength — Baseline and at the end of 4 weeks
    The grip strength will be measured using a Jamar hand dynamometer.
  • Isometric Muscle Strength — Baseline and at the end of 8 weeks.
    Wrist isometric flexion and extension muscle strength will be assessed using the Nicholas MMT Hand-Held dynamometer.
  • Functional Activity — Baseline and at the end of 4 weeks
    Functional activity will be assessed using the DASH (Disability of the Arm, Shoulder, and Hand) questionnaire.

Trial sites (1)

FacilityCityRegionStatus
Gülhane Training and Research Hospital, Clinic of Sports Medicine Ankara Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07782723 on ClinicalTrials.gov ↗ ← All trials in Turkey