Study Summary
This trial will test whether deep brain stimulation of the subgenual cingulate cortex can help people with chronic low back pain that hasn't responded to other treatments.
- Chronic Lower Back Pain
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
3 Primary · 17 Secondary · Reporting Duration: 18 months - the end of the study
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Active Stimulation
1 of 2
Sham Stimulation
1 of 2
Experimental Treatment
Non-Treatment Group
16 Total Participants · 2 Treatment Groups
Primary Treatment: Deep Brain Stimulation of the Subgenus Cingulate Cortex · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 40 - 75 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Does this research program have an age restriction, and if so what is it?
"This trial's enrolment rules dictate that the minimum age for applicants is fifty, while the cap on participation is set at seventy-five." - Anonymous Online Contributor
Are there any slots available for patients to join this clinical investigation?
"Reportedly, this clinical investigation is presently recruiting patients. This trial was initially posted on May 1st 2021 and the most recent revision occurred on May 27th 2022." - Anonymous Online Contributor
Do I meet the criteria for participating in this medical experiment?
"Candidates with low back pain aged between 50 and 75 years old are invited to apply for the trial, which is limited to a cohort of 16 participants." - Anonymous Online Contributor
What is the aim of this medical experiment?
"This 12-month clinical trial will measure the efficacy of a given intervention by assessing changes in pain scores from baseline as measured on the Pain Anxiety Symptoms Scale -- Short Form 20 (PASS SF-20). The quality of life, interference with daily activities and intensity of pain experienced are also to be tracked via responses to questionnaires such as the NIH Toolbox Pain Interference Computer Adaptive Test (CAT) and PROMIS Pain Intensity Scale 3a. A score change of at least 50% is desired when compared against baseline data." - Anonymous Online Contributor
How many individuals are actively participating in this investigation?
"Affirmative, clinicaltrials.gov's archives give evidence that this trial is accepting participants at present. The original posting of the study dates back to May 1st 2021 and was last refreshed on May 27th 2022. Recruitment aims for a total of 16 patients from one medical centre." - Anonymous Online Contributor