- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07782723
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial
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.
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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 (Kraushaar & Nirschl, 1999). It is most commonly seen in individuals aged 40-59, with a prevalence of 1.3% (Zhang et al., 2024). Common risk factors include female gender, obesity, a history of smoking, repetitive activities, and ipsilateral rotator cuff dysfunction (Shiri et al., 2006). 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 (Shiri & Viikari-Juntura, 2011; G et al., 2024).
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 (Lai et al., 2018). 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 (Yoon et al., 2020). 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 (Zhang et al., 2011). 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 (Murat et al., 2024; Pettrone & McCall, 2005).
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 (Patterson et al., 2019). 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 (Gorgey et al., 2016; Scott et al., 2014). Studies investigating the effects of BFR on lateral epicondylitis have shown that it reduces pain, increases grip strength, and contributes to functional improvement (Karanasios et al., 2022; Kinandana et al., 2023).
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Ankara, Turkki (Türkiye), 06010
- Rekrytointi
- Gülhane Training and Research Hospital, Clinic of Sports Medicine
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Ottaa yhteyttä:
- Bihter AKINOĞLU, Assoc. Prof. Dr.
- Puhelinnumero: +905059384136
- Sähköposti: bakinoglu@aybu.edu.tr
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Ottaa yhteyttä:
- Merve GÖRGÜLÜ, PT, MSc Student
- Puhelinnumero: +905075916424
- Sähköposti: merve3694@gmail.com
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnancy
- Use of oral contraceptives
- Patients with a pacemaker
- History of trauma to the upper extremity within the past 6 months or 1 year
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: Extracorporeal Shock Wave Therapy
Participants in this group will receive ESWT treatment once a week for 4 weeks for their elbows, which have been diagnosed with lateral epicondylitis.
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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.
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Kokeellinen: Extracorporeal Shock Wave Therapy and Blood Flow Restriction 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.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Pain Intensity
Aikaikkuna: Baseline and at the end of 4 weeks
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Pain intensity at rest, during activity, and at night will be assessed using the Visual Analog Scale (VAS).
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Baseline and at the end of 4 weeks
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Grip Strength
Aikaikkuna: Baseline and at the end of 4 weeks
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The grip strength will be measured using a Jamar hand dynamometer.
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Baseline and at the end of 4 weeks
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Isometric Muscle Strength
Aikaikkuna: Baseline and at the end of 8 weeks.
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Wrist isometric flexion and extension muscle strength will be assessed using the Nicholas MMT Hand-Held dynamometer.
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Baseline and at the end of 8 weeks.
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Functional Activity
Aikaikkuna: Baseline and at the end of 4 weeks
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Functional activity will be assessed using the DASH (Disability of the Arm, Shoulder, and Hand) questionnaire.
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Baseline and at the end of 4 weeks
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Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Kyynärpään tendinopatia
- Kyynärpään vammat
- Tuki- ja liikuntaelinten sairaudet
- Lihassairaudet
- Haavat ja vammat
- Jänteiden vammat
- Käsien vammat
- Tendinopatia
- Tenniskyynärpää
- Terapeuttiset lääkkeet
- Fysioterapiatapa
- Potilashoito
- Liikuntahoito
- Kuntoutus
- Jälkihoito
- Potilaan hoidon jatkuvuus
- Ultraäänihoito
- Diatermia
- Hypertermia, indusoitu
- Verenvirtaushoito
- Kehon ulkopuolinen shokki -aaltohoito
Muut tutkimustunnusnumerot
- BA-LE-BFR
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