Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Octane Innovation Inc.
With
Limestone Clinical Trial Unit
Kingston Health Sciences Centre
Providence Care, Kingston, ON, Canada
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able to provide informed consent;
Aged 18-65;
Pain intensity of at least 5 on a numerical rating scale (0-10);
Experiencing chronic low back pain that has persisted for ≥3 months;
Pain localized primarily to the lumbar spine region;
Conservative treatments, such as physical therapy, NSAIDs and lifestyle changes, have failed over the past 6 months. Participants are allowed to continue conservative treatments, but changes to use/frequency will be tracked; and
Must be able to attend 5 in-person clinic appointments over the 13-week study period.
You may not be if
Began using new prescription medication for pain within the past 3 months;
Lumbar spine surgery (within the past 12 months);
Body Mass Index (BMI)\> 35. The device may have diminished effectiveness and/or may not fit individuals with high BMI;
Presence of a cardiac pacemaker;
Pregnancy or breastfeeding;
Presence of ferromagnetic implants or body piercings (e.g., navel piercings) in the lumbar region, including hip implants/replacements or similar in the pelvic region, that could interfere with device function;
Inability to put on, adjust, and/or operate the wearable device without assistance;
Prior use of PEMF, or other electromagnetic field-emitting device, for the treatment of pain symptoms;
No, or inconsistent, access to internet (emailed surveys are used for daily data collection); and
Any condition or diagnosis that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
