Lateral EpicondylitisNCT07782723
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
A study testing Blood Flow Restriction Therapy and Extracorporeal Shock Wave Therapy in people with Lateral Epicondylitis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Blood Flow Restriction Therapy and Extracorporeal Shock Wave Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Pregnancy
- Use of oral contraceptives
- Patients with a pacemaker
- History of trauma to the upper extremity within the past 6 months or 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gülhane Training and Research Hospital, Clinic of Sports Medicine
Ankara, 06010
Bihter AKINOĞLU, Assoc. Prof. Dr., +905059384136, bakinoglu@aybu.edu.tr
Merve GÖRGÜLÜ, PT, MSc Student, +905075916424, merve3694@gmail.com
About this study
Official title: The Effects Of Combining Blood Flow Restriction Therapy With Extracorporeal Shock Wave Therapy On Pain, Muscle Strength, And Functional Outcomes İn Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Blood Flow Restriction Therapy, Extracorporeal Shock Wave Therapy
- Keywords
- lateral epicondylitis, blood flow restriction, extracorporeal shock wave therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TherapyOther
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 TherapyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blood Flow Restriction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at the end of 4 weeks
Grip Strength
The grip strength will be measured using a Jamar hand dynamometer.
Measured: 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.
Measured: 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).
Measured: Baseline and at the end of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start3 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Aslanyurek, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782723
- Sponsor's protocol ID
- BA-LE-BFR
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 36099170Scott 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.
PubMed 24715613Gorgey 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.
PubMed 27155846Patterson 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.
PubMed 31156448Pettrone 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.
PubMed 15930540Murat 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.
PubMed 38940482Zhang 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.
PubMed 22009294Yoon 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.
PubMed 32332245Lai 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.
PubMed 30464656G 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.
PubMed 38957235Shiri 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.
PubMed 21663849Shiri 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.
PubMed 16968862Zhang 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.
PubMed 39198038Kraushaar 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.
PubMed 10073590
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Combining Blood Flow Restriction Therapy With Extracorporeal Shock Wave Therapy On Pain, Muscle Strength, And Functional Outcomes İn Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07782723
- Acronym / sponsor ID
- BA-LE-BFR
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral epicondylitis, blood flow restriction, extracorporeal shock wave therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Active comparator | Other: Extracorporeal Shock Wave TherapyParticipants in this group will receive ESWT treatment once a week for 4 weeks for their elbows, which have been diagnosed with lateral epicondylitis. |
| Extracorporeal Shock Wave Therapy and Blood Flow Restriction Therapy | Experimental | Other: Blood Flow Restriction TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction TherapyFor 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. | Other | Extracorporeal Shock Wave Therapy and Blood Flow Restriction Therapy |
| Extracorporeal Shock Wave TherapyExtracorporeal 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. | Other | Extracorporeal Shock Wave Therapy |
Primary outcome
Pain Intensity
Time frame: 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). 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.
Grip Strength
Time frame: Baseline and at the end of 4 weeks
The grip strength will be measured using a Jamar hand dynamometer.
Isometric Muscle Strength
Time frame: 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
Time frame: Baseline and at the end of 4 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- BackgroundKinandana, 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: PubMed 36099170Karanasios 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.
- Background: PubMed 24715613Scott 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.
- Background: PubMed 27155846Gorgey 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.
- Background: PubMed 31156448Patterson 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.
- Background: PubMed 15930540Pettrone 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.
- Background: PubMed 38940482Murat 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.
- Background: PubMed 22009294Zhang 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.
- Background: PubMed 32332245Yoon 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.
- Background: PubMed 30464656Lai 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.
- Background: PubMed 38957235G 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.
- Background: PubMed 21663849Shiri 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.
- Individual participant dataSharing planned: No
Related trials for Lateral Epicondylitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülhane Training and Research Hospital, Clinic of Sports Medicine
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Therapy and Extracorporeal Shock Wave Therapy in people with Lateral Epicondylitis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline and at the end of 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782723, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.