N/A
N=16
Hippocampal Stimulation in Chronic Low Back Pain
Chronic Pain · Back Pain · Pain
Bottom Line
View on ClinicalTrials.gov: NCT04888494 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Changes in Pain Scales — 4.6; 4.6; 4; 4.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device); Sham rTMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Pain Scales |
4.6; 4.6; 4; 4.4 | — |
| SECONDARY Changes in Hippocampal Connectivity |
— | — |
Summary
In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with chronic low back pain.
Eligibility Criteria
Inclusion Criteria
- ≥ 6 months of back pain on a daily basis;
- male or female with no racial or ethnic restrictions;
- 18 to 75 years old;
- average back pain intensity > 4/10 at study entry;
- must be able to read, understand, and sign consent form;
- generally healthy.
Exclusion Criteria
- back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- history of tumor in the back;
- back surgery within the past 6 months;
- Chronic neurologic conditions, e.g., Parkinson's
- involvement in litigation regarding back pain;
- other severe medical diseases;
- pregnancy;
- positive urinary screen for any recreational drugs,
- opioids use;
- use of anticoagulants (low dose ASA allowed);
- history of gastric ulcer; renal insufficiency or congestive heart failure,
- contraindication to MRI,
- contraindication to TMS; including history of seizure/epilepsy*
- Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
- In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
- Diagnosis of major depression;
- Intra-axial implants (e.g. spinal cord stimulators or pumps)
Data sourced from ClinicalTrials.gov (NCT04888494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.