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

Primary Purpose

Lateral Epicondylitis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy(ESWT)
Peloid therapy
Home Workout Program
Cold application
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Extracorporeal Shock Wave Therapy, Peloidotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Peloid Therapy

ESWT(Extracorporeal Shock Wave Therapy)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2021
Last Updated
February 6, 2021
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04748406
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Extracorporeal Shock Wave Therapy, Peloidotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was designed as prospective, case-control and hospital-based.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peloid Therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
ESWT(Extracorporeal Shock Wave Therapy)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy(ESWT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Peloid therapy
Intervention Description
Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week
Intervention Type
Other
Intervention Name(s)
Home Workout Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cold application
Intervention Description
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 Measure Information:
Title
Descriptive Characteristics of Patients
Description
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.
Time Frame
All evaluations will be applied one time by the same investigator in both groups, at the beginning of the treatment.
Title
Evaluation of Grip Force Change
Description
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.
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.
Title
Evaluation of Subjective Pain Intensity Change
Description
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.
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.
Title
Treatment Satisfaction Level Change
Description
"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.
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.
Title
Evaluation of Functionality Level Change
Description
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.
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.
Title
Evaluation of Functionality Level Change
Description
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.
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.
Title
Evaluation of Quality of Life Change
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hasan koru
Phone
09005312746347
Email
hasan.koru10@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hasan koru
Organizational Affiliation
assistant doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
City
Selçuklu
State/Province
Konya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hasan koru
Phone
09005312746347
Email
hasan.koru10@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
1 year after publication in the journal under sci
IPD Sharing Time Frame
April 2023 - April 2025
IPD Sharing Access Criteria
1 year after publication in the journal under sci
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Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis

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