Extended Home-use Trial of a Novel Device to Reduce Chronic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-treatment Lyme Disease Syndrome
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Neuropathic Pain Symptom Inventory
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain.
The Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into the forehead area that measures HRV throughout the use of the device.
The system runs for 15 min at a time and is not FDA approved.
The trial will last a total of 14 weeks.
50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai.
Investigators
David Putrino
Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •Confirmed clinical diagnosis of neuropathic pain AND
- •Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome
- •Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:
- •Well-defined Lyme disease meeting CDC Surveillance Definition
- •Erythema Migrans
- •History of possible exposure to a high incidence county or state (or an adjacent area)
- •Erythema migrans rash
- •EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)
- •EM 1A: MOA self-report \& medical record documentation of rash \> 5 cm
- •EM 1B: MOA: self-report and medical record documentation of EM rash but not size
Exclusion Criteria
- •Diagnosis of photosensitive epilepsy
- •Ear or eye infection
- •Vision impairments that affect perception of light in one or both eyes
- •Deafness in one or both ears
- •Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if participants self- report having anxiety)
Outcomes
Primary Outcomes
Neuropathic Pain Symptom Inventory
Time Frame: Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-10 with higher score indicating more symptom. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Secondary Outcomes
- Pittsburgh Sleep Quality Index (PSQI)(Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Beck Depression Inventory (BDI)(Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- General Anxiety Disorder 7-item questionnaire (GAD-7)(Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Patient's Global Impression of Change (PGIC)(Post-assessment (Week 10); Follow up (Week 14))
- Visual analogue scale (VAS)- Pain(VAS-Pain: before and after each time they use the device up to 14 weeks)
- Visual analogue scale (VAS)- Sleep(VAS-Sleep: once/day up to 14 Weeks)