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NCT07782723
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial
Conditions: Lateral Epicondylitis
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 52
Sponsor: Ankara Yildirim Beyazıt University
Location: Gülhane Training and Research Hospital, Clinic of Sports Medicine Ankara
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 Criteria
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
Source: ClinicalTrials.gov (NCT07782723). StuddyBuddy aggregates publicly available trial information.