Using infrared imaging to assess spinal cord stimulation effects in CRPS patients
The Effect of Spinal Cord Stimulation on Thermal Forward Looking InfraRed (FLIR) Imaging in Complex Regional Pain Syndrome (CRPS)
This study is testing if infrared imaging can help track changes in pain and quality of life for people with Complex Regional Pain Syndrome after they receive spinal cord stimulation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05777889 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Forward Looking InfraRed (FLIR) imaging in monitoring sympathetic activity in patients with Complex Regional Pain Syndrome (CRPS) before and after spinal cord stimulation (SCS). It will assess whether SCS enhances sympatholytic activity and how this correlates with various outcome measures, including pain levels and quality of life. Participants will have thermal images of their feet taken and will complete questionnaires regarding their symptoms and functional capacity. The study seeks to provide insights into the relationship between SCS and sympathetic dysfunction in CRPS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with CRPS who have not responded to conventional treatments and have significant pain levels.
Not a fit: Patients with other underlying conditions affecting sympathetic function or those with specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients suffering from CRPS.
How similar studies have performed: While the use of FLIR imaging in this context is relatively novel, similar studies have shown promise in assessing sympathetic activity in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient is between 18 and 85 years old * Providing CRPS diagnostic criteria by using the Budapest Clinical Diagnostic Criteria. * CRPS affecting unilateral lower extremity * The patient has had pain and other symptoms for more than 3 months * Not responding to conventional medical treatments and multidisciplinary approach * High NRS detection in pain assessment despite appropriate treatment (NRS= and \> 6/10). * Pain causing a limitation in the patient's functional capacity despite appropriate treatment. Exclusion Criteria: * Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT). * Systemic or local infection * Coagulation disorders * History of allergy to contrast material * Malignancy * Pregnancy * Uncontrollable medical and psychiatric condition * The patients diagnosed with dysautonomia, sympathetic dysfunction other than CRPS (such as Raynaud disease or Buerger disease), sweating disorders other than CRPS (such as acquired idiopathic generalized anhidrosis), and patients
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Semih Gungor, MD — Hospital for Special Surgery, New York
- Study coordinator: Pa Thor, PhD
- Email: thorp@hss.edu
- Phone: 646-797-8535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.