Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Hunter Clinical Research
Location: 220 Denison Street Broadmeadow, NSW 4567
Lead Doctors: Dr Russo
Ethics Committee: Reviewed and approved by the Bellberry Human Research Ethics Committee
Background
The Hunter Clinical Research is partaking in a national research study investigating an implantable stimulation device for those with chronic low back pain. The device stimulates the nerves responsible for contracting key muscles that stabilize the lower back. The device is implanted near these muscles and is designed to restore muscle control, stabilize the spine, rehabilitate the lower back, and alleviate chronic low back pain.
Those interested will be eligible for enrolment if they have had continuing back pain for more than 90 days. All participants will be given the chance to consult with the study doctor as well as their own physician.
Benefits of Participation
- You will be equipped with the implanted ReActiv8 device free of charge.
- Participation may positively affect chronic low back pain and help rehabilitate the back.
- Qualified medical professionals will supervise the study.
- You will be helping to advance medical research.
Your Rights
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
- Your medical records relating to this study and any other relevant information will be kept strictly confidential.
- Upon completion, the results of the study will be shared with you.
Who Can Participate?
- Males and Females aged 18 to 65.
- Chronic low back pain for at least 90 days.
- Willing to have the ReActiv8 device implanted.