Back Pain Lower Back Chronic Clinical Trial
Official title:
Re-engineering Precision Therapeutics Through N-of-1 Trials
Verified date | February 2021 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Personalized Trial of Chronic Lower Back Pain will test the feasibility of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified back pain. Participants will spend 14 weeks alternating between massage, yoga, and usual care methods to treat their back pain, while answering daily questions and wearing an activity tracker. After 14 weeks, participants will have the ability to share their opinions about a Personalized Trials platform. We believe a Personalized Trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.
Status | Completed |
Enrollment | 57 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years of age - Fluent in English - Experiencing symptoms of low back pain for > 12 weeks - Self-reported pain intensity > 8 on the PROMIS pain intensity scale during screening - Able to receive massage and yoga interventions (2x/week between 8 am and 10 pm) - Owns and can regularly access a smartphone capable of receiving text messages - Owns and can regularly access an e-mail account Exclusion Criteria: - Pregnant women - History of spinal surgery - Complex back pain (e.g. sciatica, spinal stenosis, or other pre-existing condition) - Previous diagnosis of a serious mental health condition or psychiatric disorder - Previous diagnosis of opioid use disorder or treatment for any substance use disorder - Previously advised that yoga or massage is unsafe for their condition - Current opioid use - Current physical activity restrictions - Planned surgery or procedures within 6 months of recruitment - Planned travel outside the United States within treatment period time-frame - Weight greater than or equal to 500 lbs. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Personalized Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean System Usability Score | Usability of the Personalized Trials platform will be evaluated using the System Usability Scale (SUS), a 10-item questionnaire created by Digital Equipment Co Ltd. and John Brooke in 1986 that asks users to score each item on a Likert scale from Strongly Disagree (1) to Strongly Agree (5). Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together. Higher scored values correlate to a more usable system, and therefore a better outcome. | Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion | |
Secondary | Mean Participant Satisfaction with Personalized Trials Components | Participant satisfaction rated on a 5-point Likert scale from Very Dissatisfied (1) to Very Satisfied (5), or Strongly Disagree (1) to Strongly Agree (5). Higher scores correlate to greater satisfaction, and therefore a better outcome. | Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion | |
Secondary | Mean Within-Subject Difference in Self-Reported Daily Pain Intensity During 3 Treatment Periods from Mean Baseline | Pain intensity is measured using the PROMIS Scale v1.0 - Pain Intensity 3a Fixed Length Short Form. The measure is modified from instructions to recall over the last 7 days to recall over the last 24 hours. Raw scores will be converted to an item response theory-based T-score using the PROMIS scoring manual. A T-score of 50 is the average for the US general population with an SD of 10. A higher T-score represents higher pain intensity or interference. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6 | |
Secondary | Mean Within-Subject Difference in Self-Reported Daily Pain Interference During 3 Treatment Periods from Mean Baseline | Pain interference is measured using a PROMIS Short Form v1.0 - Pain Interference 4a Fixed Length Short Form. The measure is modified from instructions to recall over the last 7 days to recall over the last 24 hours. Raw scores will be converted to an item response theory-based T-score using the PROMIS scoring manual. A T-score of 50 is the average for the US general population with an SD of 10. A higher T-score represents higher pain intensity or interference. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6 | |
Secondary | Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Pain During 3 Treatment Periods from Mean Baseline | Numeric Pain Rating Scale adapted from McCaffery, Beebe et al. 1989 Numeric Pain Rating Scale, assessing current Pain level on a scale from 0 (none) to 10 (severe). Higher scores correlate to a worse outcome. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6 | |
Secondary | Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Fatigue During 3 Treatment Periods from Mean Baseline | Numeric Fatigue Rating Scale adapted from McCaffery, Beebe et al. 1989, assessing current Fatigue level on a scale from 0 (none) to 10 (severe). Higher scores correlate to a worse outcome. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6 | |
Secondary | Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Stress During 3 Treatment Periods from Mean Baseline | Numeric Stress Rating Scale adapted from McCaffery, Beebe et al. 1989, assessing current Stress level on a scale from 0 (none) to 10 (severe). Higher scores correlate to a worse outcome. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6 | |
Secondary | Mean Within-Subject Difference in Self-Reported Use of Pain Medication from Baseline | Average number of pain medication pills self-reported by participants as taken to manage their back pain. Daily question to quantify how many pain pills taken in the last 24 hours, and of what type and dosage. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6 | |
Secondary | Mean Within-Subject Difference in Device-Recorded Daily Steps from Mean Baseline | Average participant daily step data, as recorded by a Fitbit Charge 3 device. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks. | |
Secondary | Mean Within-Subject Difference in Device-Recorded Nightly Sleep from Mean Baseline | Average participant sleep minutes and sleep stage minute estimates, as recorded by a Fitbit Charge 3 device. | From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01914666 -
An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
|
Phase 3 | |
Completed |
NCT01761617 -
Yoga Dosing Study for Chronic Low Back Pain
|
N/A | |
Completed |
NCT03338192 -
Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
|
||
Completed |
NCT03106740 -
Evaluating the Role of Neuroinflammation in Low Back Pain
|
Phase 2 | |
Completed |
NCT02960269 -
Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing
|
N/A | |
Not yet recruiting |
NCT05704751 -
EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
|
||
Completed |
NCT06351774 -
Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
|
N/A | |
Completed |
NCT01855919 -
A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
|
Phase 3 | |
Terminated |
NCT01865539 -
Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
|
N/A | |
Enrolling by invitation |
NCT05386212 -
The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures
|
||
Completed |
NCT03299192 -
Tai Chi for Chronic Low Back Pain in Older Adults
|
N/A | |
Completed |
NCT01081912 -
Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
|
Phase 3 | |
Completed |
NCT04468074 -
Virtual Reality Treatment for Adults With Chronic Back Pain
|
N/A | |
Completed |
NCT01343927 -
Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations
|
N/A | |
Terminated |
NCT01125917 -
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
|
Phase 3 | |
Completed |
NCT01329861 -
Internet-based Cognitive Behavioural Treatment for Chronic Back Pain
|
N/A | |
Enrolling by invitation |
NCT05413070 -
Quality Improvement re: Choosing Wisely Back Pain Measures
|
||
Not yet recruiting |
NCT06401499 -
The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination
|
Phase 4 | |
Recruiting |
NCT04893720 -
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
|
||
Recruiting |
NCT05953155 -
YOga for Patients With Chronic BACK Pain and Poor PROgnosis
|
N/A |