Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2024-05-08
2025-01-22
Brief Summary
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Whether the BTL-899 device is able to change musculoskeletal system perception before and after treatment, based on the Subject Satisfaction questionnaire.
Participants will complete four treatments, and two follow-up visits.
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Detailed Description
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At the baseline visit, the subject's weight will be recorded and subjects will fill in the Western Ontario and McMaster Universities questionnaire.
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the designated area. Each therapy session will last 30 minutes.
At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Therapy Comfort, Subject Satisfaction Questionnaire and Western Ontario and McMaster Universities questionnaire to fill in.
Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subject's satisfaction, Western Ontario and McMaster Universities questionnaire, and weight will be recorded. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment with BTL-899
Four (4) BTL-899 treatments will be applied to the impaired musculoskeletal area, either on the upper or lower extremity.
Treatment with BTL-899
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 device will be applied over the designated area. Each treatment session will last 30 minutes.
Interventions
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Treatment with BTL-899
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 device will be applied over the designated area. Each treatment session will last 30 minutes.
Eligibility Criteria
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Inclusion Criteria
* Voluntarily signed an informed consent form
* BMI ≤ 35 kg/m2
* Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime and the study procedure for improvement of the musculoskeletal system
* Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change in either direction during study participation
Exclusion Criteria
* Metal implants
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Application over muscles in acute phase of injury
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions, blood coagulation disorders or anticoagulation therapy.
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy, postpartum period, nursing, and menstruation
* A metal-containing intrauterine device (IUD)
* Graves' disease
22 Years
ALL
Yes
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Trokhan Orthopaedics LLC
Closter, New Jersey, United States
New York Orthopedic Hand Surgery
Brooklyn, New York, United States
Southeast Texas Orthopedic Group
Houston, Texas, United States
Countries
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Other Identifiers
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BTL-899_CTUS900
Identifier Type: -
Identifier Source: org_study_id
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