An interventional study of Blood Flow Restriction Therapy and Extracorporeal Shock Wave Therapy in Lateral Epicondylitis, sponsored by Ankara Yildirim Beyazıt University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment
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.
Lateral epicondylitis is a form of tendinitis characterized by pain at the attachment site of the common extensor tendons of the wrist to the lateral epicondyle, resulting from inflammation and degeneration. It is most commonly seen in individuals aged 40-59, with a prevalence of 1.3%. Common risk factors include female gender, obesity, a history of smoking, repetitive activities, and ipsilateral rotator cuff dysfunction. Typically, pain on the lateral aspect of the elbow and forearm, restricted range of motion in the elbow and wrist joints, decreased muscle strength, and loss of function may be observed due to repetitive forearm supination/pronation and wrist extension.
Treatment options include medical (oral and topical nonsteroidal anti-inflammatory drugs, local corticosteroid injections), conservative (cryotherapy, orthoses, electrotherapy, etc.), and surgical methods. Among conservative methods, Extracorporeal Shock Wave Therapy (ESWT) is frequently preferred. ESWT is a non-invasive method that utilizes high-frequency acoustic waves for therapeutic purposes in target tissues. This method supports tissue regeneration by enhancing angiogenesis at the tendon-bone junction through the stimulation of vascular endothelial growth factors and nitric oxide synthesis, and reduces pain by inhibiting pain receptors. Additionally, it triggers the release of lubricin, which facilitates tendon repair and gliding by stimulating tenocyte proliferation through increased expression of TGFβ1 and IGF-1. The literature has demonstrated that ESWT has effects on lateral epicondylitis, such as alleviating pain, shortening recovery time, increasing grip strength, and enabling patients to return to their daily activities.
Another conservative method used in the treatment of lateral epicondylitis is Blood Flow Restriction Therapy (BFR). In this method, arterial blood flow is partially restricted and venous return is blocked by applying an external device (tourniquet or adjustable-pressure cuff) to the proximal part of the extremity. This causes the targeted muscle group to work in an ischemic, hypoxic environment, triggering a significant increase in muscle mass and strength by activating fast-twitch muscle fibers. Studies investigating the effects of BFR on lateral epicondylitis have shown that it reduces pain, increases grip strength, and contributes to functional improvement.
In the literature, the effects of both methods on lateral epicondylitis have been examined separately, but their efficacy has not been compared. Therefore, the aim of our study is to compare the efficacy of extracorporeal shock wave therapy (ESWT) and blood flow restriction therapy (BFR) in patients with lateral epicondylitis. By comparing different treatment methods that can be used in the management of lateral epicondylitis symptoms, our study will contribute to the use of more personalized and effective treatment strategies by healthcare professionals and will serve as a guide for future research.
296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.
This study's planned enrollment of 52 is close to the median of 50 across 262 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
Pain Intensity
Pain intensity at rest, during activity, and at night will be assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm horizontal line, with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity, i.e., a worse outcome.
Time frame: Baseline and at the end of 4 weeks
Grip Strength
The grip strength will be measured using a Jamar hand dynamometer.
Time frame: 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.
Time frame: 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. The questionnaire consists of three sections. The first section includes 30 items assessing upper extremity function and symptoms. The second section is a 4-item optional Sports/Performing Arts Module for individuals who play sports or musical instruments. The third section is a 4-item optional Work Module assessing difficulty in work-related activities. Each item is scored from 1 to 5 (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: severe difficulty, 5: unable). Each section is scored separately and transformed to a scale of 0 to 100, with higher scores indicating greater disability (a worse outcome).
Time frame: Baseline and at the end of 4 weeks
Plan to share: No
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
Of 152 non-industry interventional studies with no phase under Tennis Elbow, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 24 months is above that.
Counting every sponsor, half of 154 studies reached it within 8 months; a quarter within 5 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ankara Yildirim Beyazıt University →