Lateral EpicondylitisNCT04748406
Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis
A study testing Extracorporeal Shock Wave Therapy(ESWT), Peloid therapy and Home Workout Program in people with Lateral Epicondylitis, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Extracorporeal Shock Wave Therapy(ESWT), Peloid therapy and Home Workout Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
Selçuklu, Konya
hasan koru, 09005312746347, hasan.koru10@gmail.com
About this study
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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Extracorporeal Shock Wave Therapy(ESWT), Peloid therapy, Home Workout Program, Cold application
- Keywords
- Extracorporeal Shock Wave Therapy, Peloidotherapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy(ESWT)Device
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.
Peloid therapyOther
Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week
Home Workout ProgramOther
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.
Cold applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peloid Therapy | Active comparator | 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). Receives: Other: Peloid therapy; Other: Home Workout Program; Other: Cold application |
| ESWT(Extracorporeal Shock Wave Therapy) | Active comparator | 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). Receives: Device: Extracorporeal Shock Wave Therapy(ESWT); Other: Home Workout Program; Other: Cold application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Characteristics of Patients
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.
Measured: All evaluations will be applied one time by the same investigator in both groups, at the beginning of the treatment.
Evaluation of Grip Force Change
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.
Measured: 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.
Evaluation of Subjective Pain Intensity Change
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.
Measured: 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.
Treatment Satisfaction Level Change
"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.
Measured: 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.
Evaluation of Functionality Level Change
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.
Measured: 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.
Evaluation of Functionality Level Change
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.
Measured: 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.
Evaluation of Quality of Life Change
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Dec 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as prospective, case-control and hospital-based.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Koru, Konya Meram State Hospital
- Investigators
- hasan koru, Principal investigator, assistant doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748406
- Sponsor's protocol ID
- KonyaTRH1
- Status last verified
- Feb 2021
- First submitted
- 16 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1 year after publication in the journal under sci
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.
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.
PubMed 169688624.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.
Derebery VJ, Devenport JN, Giang GM, Fogarty WT. The effects of splinting on outcomes for epicondylitis. Arch Phys Med Rehabil. 2005 Jun;86(6):1081-8. doi: 10.1016/j.apmr.2004.11.029.
PubMed 159540446. Ölmez N, Memiş A. Lateral Epikondilit Tedavisinde Kanıta Dayalı Veriler. Rewiev . Turkiye Klinikleri J Med Sci 2010;30(1)
Foley AE. Tennis elbow. Am Fam Physician. 1993 Aug;48(2):281-8.
PubMed 8342481Wilson JJ, Best TM. Common overuse tendon problems: A review and recommendations for treatment. Am Fam Physician. 2005 Sep 1;72(5):811-8.
PubMed 161563399. 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.
Fioravanti A, Bacaro G, Giannitti C, Tenti S, Cheleschi S, Gui Delli GM, Pascarelli NA, Galeazzi M. One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial. Int J Biometeorol. 2015 Sep;59(9):1333-43. doi: 10.1007/s00484-014-0943-0. Epub 2014 Dec 17.
PubMed 25516113Liu H, Zeng C, Gao SG, Yang T, Luo W, Li YS, Xiong YL, Sun JP, Lei GH. The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2013 Oct;41(5):1418-25. doi: 10.1177/0300060513488509. Epub 2013 Sep 5.
PubMed 24008567Espejo-Antunez L, Cardero-Duran MA, Garrido-Ardila EM, Torres-Piles S, Caro-Puertolas B. Clinical effectiveness of mud pack therapy in knee osteoarthritis. Rheumatology (Oxford). 2013 Apr;52(4):659-68. doi: 10.1093/rheumatology/kes322. Epub 2012 Dec 11.
PubMed 23236190Tefner IK, Gaal R, Koroknai A, Rathonyi A, Gati T, Monduk P, Kiss E, Kovacs C, Balint G, Bender T. The effect of Neydharting mud-pack therapy on knee osteoarthritis: a randomized, controlled, double-blind follow-up pilot study. Rheumatol Int. 2013 Oct;33(10):2569-76. doi: 10.1007/s00296-013-2776-2. Epub 2013 May 21.
PubMed 23689969
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04748406
- Acronym / sponsor ID
- KonyaTRH1
- Conditions
- Lateral Epicondylitis
- Keywords
- Extracorporeal Shock Wave Therapy, Peloidotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Feb 2021 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was designed as prospective, case-control and hospital-based.
| Arm | Type | Receives |
|---|---|---|
| Peloid Therapy | Active comparator | Other: Peloid therapy, Other: Home Workout Program, Other: Cold applicationGroup 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week(16). |
| ESWT(Extracorporeal Shock Wave Therapy) | Active comparator | Device: Extracorporeal Shock Wave Therapy(ESWT), Other: Home Workout Program, Other: Cold applicationGroup 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| 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. | Device | ESWT(Extracorporeal Shock Wave Therapy) |
| Peloid therapyGroup 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week | Other | Peloid Therapy |
| Home Workout ProgramPatients 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 | ESWT(Extracorporeal Shock Wave Therapy), Peloid Therapy |
| Cold applicationAt 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. | Other | ESWT(Extracorporeal Shock Wave Therapy), Peloid Therapy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background1.Barrington J, Hage W. Lateral epicondylitis (tenis elbow): nonoperative, open, or arthroscopic treatment?. Curr Opin Orthop 2003; 14: 291-295.
- Background2.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.
- Background: PubMed 16968862Shiri 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.
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- Background: PubMed 15954044Derebery VJ, Devenport JN, Giang GM, Fogarty WT. The effects of splinting on outcomes for epicondylitis. Arch Phys Med Rehabil. 2005 Jun;86(6):1081-8. doi: 10.1016/j.apmr.2004.11.029.
- Background6. Ölmez N, Memiş A. Lateral Epikondilit Tedavisinde Kanıta Dayalı Veriler. Rewiev . Turkiye Klinikleri J Med Sci 2010;30(1)
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- Individual participant dataSharing planned: Yes. 1 year after publication in the journal under sci
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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. This study is not recruiting at the moment.
hasan koru principal investigator
assistant doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy(ESWT), Peloid therapy and Home Workout Program in people with Lateral Epicondylitis, run by Konya Meram State Hospital 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 1 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hasan koru (09005312746347, hasan.koru10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 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 NCT04748406, which also lists 35 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 10 Feb 2021.