Chronic Pain Clinical Trial
Official title:
Randomized, Double Blind, Cross Over Study Comparing Effectiveness of Traditional Opioids Versus Opioids in Admixture With Bupivacaine Upon Self-administration of Boluses Via a Personal Therapy Manager (PTM) in Intrathecal Pumps
NCT number | NCT02886286 |
Other study ID # | 2-16-24 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | December 2017 |
Verified date | February 2022 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether the local anesthetic bupivacaine delivered intrathecally in small doses via PTM self-administered boluses significantly improves the breakthrough pain and functional status of patients with chronic intractable pain who are managed with an intrathecal drug delivery system.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 31 Years to 90 Years |
Eligibility | Inclusion Criteria - Age more than 30 years implanted with an intrathecal drug delivery device. - Intrathecal pump patients on stable dose for the last 3 months. - Using on average more than 2 and less than 10 PTM doses per day - Intrathecal medication admixture consisting of bupivacaine and another opioid (fentanyl or hydromorphone or morphine) Exclusion Criteria - Using 10 or more PTM bolus doses per day or 2 or less PTM bolus doses per day - Pending litigation or worker compensation claim - Any recent (less than 3 month) procedures in spine (surgeries) or catheter adjustments. - Recent pump dose adjustment within the past 3 months - Pumps with medications other than bupivacaine/opioid combination. - Pregnant or breast feeding |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in the Numerical Rating Pain Scale (NRS) | Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus.
Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain |
Before self-administered bolus using Patient Therapy Manager device (PTM) and within 30 minutes of PTM bolus | |
Secondary | Change From Baseline in Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI): calculated as a percentage based on scores from 0-5 in 10 categories (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, travelling). 0 signifies no pain interference while 5 signifies maximum possible pain interference in the 10 categories. Scores from 0-5 for 10 categories are added and divided by total possible score (50) X 100 to give percentage.
Interpretation of percentage scores: 0 - 20% minimal disability 21-40% moderate disability 41-60% severe disability 61-80% crippled 81-100% either bed bound or patient is exaggerating symptoms |
Day 0, 7, 14, score at day 7 or day 14 reported | |
Secondary | Change From Baseline in Patient Global Impression of Change (PGIC) | Patient Global Impression of Change (PGIC): reflects patient's belief about the efficacy of treatment
= very much improved = much improved = minimally improved = no change = worse = much worse = very much worse |
Day 0, 7, 14, score at day 7 or day 14 reported | |
Secondary | Change From Baseline in painDETECT | painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. A total score that ranges from -1 to 38 can be calculated from the nine items, with higher scores indicating higher levels of pain. | Day 0, 7, 14, score at day 7 or day 14 reported | |
Secondary | Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS) | Average Weekly Numeric Pain Rating Score (NRS) over the past week
Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain |
Day 0, 7, 14, score at day 7 or day 14 reported | |
Secondary | Change From Baseline in Treatment Satisfaction | A 5-point qualitative Likert scale was used to report measures of patient satisfaction (i.e., not satisfied at all, not satisfied, somewhat, satisfied, very satisfied). To quantify satisfaction, these responses were transformed to a scale of 0-4, with higher numbers representing greater levels of satisfaction. | Day 0, 7, 14, score at day 7 or day 14 reported |
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