Clinical trial NCT04748406: Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis
Official title: Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Extracorporeal Shock Wave Therapy
Peloidotherapy
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as prospective, case-control and hospital-based.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Descriptive Characteristics of Patients
timeFrame: All evaluations will be applied one time by the same investigator in both groups, at the beginning of the treatment.
measure: Evaluation of Grip Force Change
timeFrame: 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.
measure: Evaluation of Subjective Pain Intensity Change
timeFrame: 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.
measure: Treatment Satisfaction Level Change
timeFrame: 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.
measure: Evaluation of Functionality Level Change
timeFrame: 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.
measure: Evaluation of Functionality Level Change
timeFrame: 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.
measure: Evaluation of Quality of Life Change
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
state: Konya
Study officials:
affiliation: assistant doctor
name: hasan koru
role: PRINCIPAL_INVESTIGATOR
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