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Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis

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ClinicalTrials.gov Identifier: NCT04748406
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hasan Koru, Konya Meram State Hospital

Brief Summary:
Investigator could not find a study comparing ESWT(Extracorporeal Shock Wave Therapy) and Peloidotherapy methods in the treatment of lateral epicondylitis in the literature. Therefore, in this study, it was planned to investigate the difference in effectiveness between Peloidotherapy and ESWT in the treatment of Lateral Epicondylitis.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Device: Extracorporeal Shock Wave Therapy(ESWT) Other: Peloid therapy Other: Home Workout Program Other: Cold application Not Applicable

Detailed Description:

The frequency of lateral epicondylitis (LE), one of the most common causes of elbow pain, has been reported to be 1-3%. It is usually seen between the ages of 40-50 and the dominant side is more frequently affected. The most common cause of elbow lateral pain in adults is LE (1,2). Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. (3). The diagnosis of lateral epicondylitis is usually made clinically. Dorsiflexion of the wrist against resistance, pressure on the lateral epicondyle and firm grip of an object causes pain radiating to the forearm. (4). With appropriate conservative treatments, 75-90% relief has been reported in patients with LE (1). Chronic symptoms develop in 5-10% of the patients. Various treatments have been tried to reduce the pain of the patient and increase the functions in LE, which restricts daily life activities. Although many treatment methods are used in the treatment of LE disease, it is controversial which is the most effective method. Extracorporeal Shock Wave therapy (ESWT), peloidotherapy, NSAID, corticosteroid injection, cold application, fascia loosening, electrotherapy applications, kinesio band, iontophoresis, splint, orthosis, acapuntur, ultrasound therapy, deep friction massage, exercise, manipulation, mobilization, laser, Botulinum toxin injection, tenotomy, and autologous blood injections are among the recommended treatments (4-9). Although there are so many different treatment methods in the treatment of lateral epicondylitis, there is no consensus on which one is the most effective and successful.

Peloids (medicinal mud) are organic or inorganic substances formed as a result of geological and / or biological events. They can be found in nature as fine particles, or they are made into small, fine particles by some pre-preparation processes. (10). Peloidotherapy is a special balneotherapy method made with natural muds (11). It is especially used in the treatment of diseases such as degenerative joint diseases, soft tissue rheumatism, lumbar discopathy, cervical discopathy, chronic back and neck pain, joint pain. Scientific studies on peloid treatment both in Turkey and abroad have shown that patients have reduced pain (12), improved physical functions, increased quality of life, and decreased pain medication use (12-15). A recent study demonstrated the effectiveness of peloidotherapy in LE. (16). Ökmen et al. In this study, the effectiveness of peloidotherapy and elbow bandage in the treatment of LE was compared. (16). This study remains the only one investigating the effectiveness of peloidotherapy in the treatment of LE.

Shock wave therapy (extracorporeal shock wave therapy, Extracorporeal Shock Wave Therapy-ESWT) is a new orthopedic treatment method based on focusing high amplitude sound waves on the desired area of the body and providing treatment there. (17). ESWT creates a cavitation effect in deep tissue by creating capillary microrupture, chemical mediator leakage, and neovascularization in damaged tissue with low or high energy options (18). Successful results have been reported with ESWT treatment in 48-73% of cases with recurrent LE with non-surgical methods (19). Due to its non-invasive nature and low complication rates, the use of ESWT in LE treatment is gradually increasing (20). Some authors state that ESWT has lateral LE effect (20). Some authors reported that ESWT is not in the treatment of LE (21).

Investigator did not find a study comparing ESWT and Peloidotherapy methods in the treatment of LE in the literature. In this thesis, our aim is to compare the effectiveness of peloidotherapy and ESWT methods used in the treatment of LE with a prospective clinical study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study was designed as prospective, case-control and hospital-based.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Peloid Therapy
Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week(16).
Other: Peloid therapy
Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week

Other: Home Workout Program
Patients will be given a home exercise program consisting of eccentric strengthening exercises and stretching exercises, which are planned to increase resistance every week. The patients will be taught strengthening exercises for forearm pronation-supination with wrist extensors and a home exercise program will be started 3 sets of 10 repetitions per day.

Other: Cold application
At the beginning of each treatment, gel ice packs are wrapped with a moist towel and placed around the elbow joint for 15 minutes. will be applied.

Active Comparator: ESWT(Extracorporeal Shock Wave Therapy)
Group 2 (n = 35) will be applied 1 session per week for 3 weeks, 3 sessions of ESWT (1.8 bar, 10.0 Hz, 2000 beats) + cold application + home exercise program will be applied(4).
Device: Extracorporeal Shock Wave Therapy(ESWT)
Group 2 (n = 35) will be applied 1 session per week for 3 weeks, 3 sessions of ESWT (1.8 bar, 10.0 Hz, 2000 beats) + cold application + home exercise program will be applied.

Other: Home Workout Program
Patients will be given a home exercise program consisting of eccentric strengthening exercises and stretching exercises, which are planned to increase resistance every week. The patients will be taught strengthening exercises for forearm pronation-supination with wrist extensors and a home exercise program will be started 3 sets of 10 repetitions per day.

Other: Cold application
At the beginning of each treatment, gel ice packs are wrapped with a moist towel and placed around the elbow joint for 15 minutes. will be applied.




Primary Outcome Measures :
  1. Descriptive Characteristics of Patients [ Time Frame: All evaluations will be applied one time by the same investigator in both groups, at the beginning of the treatment. ]
    Patients were questioned about age, gender, body mass index (BMI), education level, occupation, the extremity affected by the dominant, duration of complaints, previous treatments and when the last treatment was administered.

  2. Evaluation of Grip Force Change [ Time Frame: All evaluations will be applied three times by the same investigator in both groups, at the beginning of the treatment, in the 3rd week after the treatment, and on the 4th week after the end of the treatment. ]
    The grip strength of the hand is accepted as the most objective criterion of the functional integrity of the upper extremity. Hand grip strength also provides convenience and objectivity in evaluating the treatment. (26). It is known that hand grip strength measurements with the Jamar hand dynamometer, which is one of the methods used for this purpose, give reliable results (22, 26, 27). Jamar dynamometer will be used in hand grip strength measurements.

  3. Evaluation of Subjective Pain Intensity Change [ Time Frame: All evaluations will be applied three times by the same investigator in both groups, at the beginning of the treatment, in the 3rd week after the treatment, and on the 4th week after the end of the treatment. ]
    Pain interrogation using a 0-10 point Visual Analogue Scale (VAS) will be used to detect pain and disability caused by the disease. The questions were pain at rest, pain during straining, pain relief effectiveness, subjective work failure, difficulty in lifting 2 kg objects, inability during hobby activities and sleep disturbance. Patients were asked to answer each question as 0 (no pain or disability) 10 (worst possible pain or disability) on a scale of 0-10 cm. The total pain score, which is the sum of 7 different sub-scores, will be calculated for each patient. In addition to 0-10 point Visual Analogue Scale (VAS) was used to evaluate the severity of pain during maximum hand grip.

  4. Treatment Satisfaction Level Change [ Time Frame: All evaluations will be applied two times by the same investigator in both groups, in the 3rd week after the treatment, and on the 4th week after the end of the treatment. ]
    "Roles and Maudsley Scoring" will be used to measure the treatment satisfaction level of the patients. The "Roles and Maudsley Scoring" is a measure of whether patients with lateral epicondylitis benefit from treatment. It is scored between 1 and 4 points. 1 point indicates that satisfaction with treatment and benefit from treatment is high. As the score level increases, the level of satisfaction and benefit from treatment decreases. 4 points show that he did not benefit from the treatment at all and he was not satisfied.

  5. Evaluation of Functionality Level Change [ Time Frame: All evaluations will be applied three times by the same investigator in both groups, at the beginning of the treatment, in the 3rd week after the treatment, and on the 4th week after the end of the treatment. ]
    Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire; The field-specific outcome measurement DASH questionnaire has been developed to evaluate functional status and symptoms in musculoskeletal disorders occurring in the upper extremity.The DASH questionnaire consists of 3 parts. The first part consists of 30 questions; 21 questions assess the patient's difficulties during daily life activities, 5 questions evaluate symptoms (pain, activity-related pain, tingling, stiffness, weakness), and each of the remaining 4 questions assess social function, work, sleep and patient self-confidence.

  6. Evaluation of Functionality Level Change [ Time Frame: All evaluations will be applied three times by the same investigator in both groups, at the beginning of the treatment, in the 3rd week after the treatment, and on the 4th week after the end of the treatment. ]
    Patient-Rated Forearm Evaluation Questionnaire(PRFEQ), a Turkish validated scoring system, is designed to assess arm pain and functions over a 1-week period. It questions how much pain and difficulty you have had with your arm over the past week. Pain is assessed with 5 questions and functions with 10 questions. The subtitles of PRFEQ related to pain are scored between 0 (no pain) and 10 (worst possible pain) on a 0-10 cm VAS scale.

  7. Evaluation of Quality of Life Change [ Time Frame: All evaluations will be applied three times by the same investigator in both groups, at the beginning of the treatment, in the 3rd week after the treatment, and on the 4th week after the end of the treatment. ]
    The SF-36 (the MOS 36-item short-form health survey) Health Survey is a 36-question questionnaire consisting of 8 subgroups to measure the general quality of life. It is filled by the patient himself. It has eight subgroups (general health, physical function, physical condition, pain, life functions, social functions, emotional state, mental health) and 2 summary scales (mental health and physical health). It is scored between 0 and 100, with 0 reporting the worst health condition, 100 the best health condition.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who present with elbow pain and are diagnosed with unilateral LE due to the presence of pain by pressing on the epicondyle in physical examination, wrist extension against resistance and during stretching of the wrist extensors, who have elbow pain for at least 3 months and between the ages of 18-65 will be accepted to the study.

Exclusion Criteria

  • Those with communication problems
  • A history of cervical and shoulder problems
  • History of injection, surgery, physical therapy in the elbow area in the last 6 months
  • Having had ESWT treatment in the elbow area before
  • History of elbow problems other than LE
  • Elbow osteoarthritis, previous elbow fracture history
  • A history of polyneuropathy,
  • Those with a history of uncontrolled systemic disease (cardiovascular, pulmonary, hepatic, renal, hematologic ..),
  • Those with a history of systemic endocrine disease (DM, hyperthyroidism ..),
  • Major psychiatric illness
  • History of rheumatic diseases such as fibromyalgia, polymyalgiaromatica, ankylosing spondylitis, rheumatoid arthritis
  • Those who use bleeding disorders and anticoagulants
  • Neurological deficit
  • Malignancy
  • Those with a history of pacemakers were not included in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748406


Contacts
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Contact: hasan koru 09005312746347 hasan.koru10@gmail.com

Locations
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Turkey
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic Recruiting
Selçuklu, Konya, Turkey
Contact: hasan koru    09005312746347    hasan.koru10@gmail.com   
Sponsors and Collaborators
Konya Meram State Hospital
Investigators
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Principal Investigator: hasan koru assistant doctor
Publications:
1.Barrington J, Hage W. Lateral epicondylitis (tenis elbow): nonoperative, open, or arthroscopic treatment?. Curr Opin Orthop 2003; 14: 291-295.
2.Chard MD. The Elbow. In Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, editors. Rheumatology. 3rd ed. Mosby, London; 2003. p. 631-9.
4.Soner Akkurt, Ahmet Yılmaz, Tolga Saka. Lateral epikondilit tedavisinde ekstrakorporeal şok dalga tedavisi, fizyoterapi ve lokal steroid enjeksiyonunun karşılaştırılması Turk J Phys Med Rehab 2016;1(62):37-44.
6. Ölmez N, Memiş A. Lateral Epikondilit Tedavisinde Kanıta Dayalı Veriler. Rewiev . Turkiye Klinikleri J Med Sci 2010;30(1)
9. Aydin A, Celepkolu T, Atiç R, Alemdar C, Aydin ZS, Cevik R. Effects of Extracorporeal Shock Wave Therapy On The Quality of Life And Pain in Patients With Lateral Epicondylitis. Euras J Fam Med 2018;7(1):29-36
10. Karagülle MZ. Balneoloji ve Kaplıca Tıbbı. İstanbul: Nobel Tıp Kitabevleri; 2002. s. 15-36.
11. Özer UN. Kaplıca Tedavisi. In: Tuna N, Eds. Romatizmal Hastalıklar. Ankara: Hacettepe Taş Kitapçılık; 1994. s. 229-42.
17.İsmail Baloğlu, M. Hakan Özsoy, Hilmi Aydınok, Veli Lök. Ortopedi ve Travmatolojide Şok Dalga Tedavisi. TOTBİD (Türk Ortopedi ve Travmatoloji Birliği Derneği) Dergisi. 2005 • Cilt: 4 Sayı: 1-2.
18. Hossain M, Makwana N. "Not Plantar Fasciitis": the differential diagnosis and management of heel pain syndrome. Orthop Trauma. 2011;25:198-206
23. Düger T, Yakut E, Öksüz Ç, Yörükan S, Bilgütay BS, Ayhan Ç, Leblebicioğlu G, Kayıhan H, Kırdı N, Yakut Y, Güler Ç. Kol, Omuz ve El Sorunları (Disabilities of the Arm, Shoulder and Hand - DASH) Anketi Türkçe uyarlamasının güvenirliği ve geçerliği. Fizyoterapi Rehabilitasyon. 2006; 17(3):99-107.
25. Koçyiğit H. Aydemir Ö, Fişek G. Kısa form-36(KF-36)'nın Türkçe versiyonunun güvenirliliği ve geçerliliği. İlaç ve Tedavi Dergisi.1999;12:102-106.
27. Üncel NA, Ceceli E, Durukan BP, Öken Ö, Erdem HR. El kavrama gücüne cinsiyet ve el dominansının etkisinin değerlendirilmesi. Romatizma, Cilt: 17, Sayı: 1, 2002.
30. Feneis H. Sistematik Resimli Anatomi Sözlüğü (Çev. Ed: Yıldırım M) s. 90-92, Nobel Yüce, İstanbul, 1997.

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Responsible Party: Hasan Koru, assistant doctor, Konya Meram State Hospital
ClinicalTrials.gov Identifier: NCT04748406    
Other Study ID Numbers: KonyaTRH1
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 1 year after publication in the journal under sci
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: April 2023 - April 2025
Access Criteria: 1 year after publication in the journal under sci

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hasan Koru, Konya Meram State Hospital:
Extracorporeal Shock Wave Therapy
Peloidotherapy
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries