Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BTL Industries Ltd.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult subjects seeking treatment for alleviating back pain, and expressing interest in treatment will be considered eligible for the study.
Enrollment of the subject will depend on meeting the following criteria:
Adults seeking alleviation of pain in the treatment area
Age 22 years and older
Voluntarily signed an informed consent form
Subject is willing to comply with study instructions, to return to the clinic for the required visits
Willingness to adhere to and continue current pain management plan
Subjects willing and able to maintain their regular (pre-procedure) diet, exercise, and therapy regimen without affecting significant change during study participation
Subject willing and able to abstain from partaking in any new treatments other than this study procedure to treat back pain
Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study
* Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
You may not be if
A potential subject who meets any of the following criteria will be excluded from participation in the study:
Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus
Ongoing pregnancy
Photosensitivity, medications affecting sensitivity to light
Tattoos or other highly-pigmented regions in the treated area
Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use
Anticoagulant therapy, bleeding disorders
Hemorrhage in the treated area
Application within 4 to 6 months after radiotherapy
Known or suspected malignancy, history of cancer or any type of malignancy
