N/A
N=59
Internet-based Behavioral Pain Management
Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01918189 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
Oct 2019
Primary outcome: Primary: Multidimensional Pain Inventory Interference Subscale — 0.53 score on a scale — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- behavioral pain self-management intervention Pain EASE (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Multidimensional Pain Inventory Interference Subscale |
0.53 | 0.008 sig |
| SECONDARY Numeric Rating Scale of Pain Intensity |
-0.24 | 0.27 |
| SECONDARY Profile of Mood States |
-9.57 | 0.02 sig |
| SECONDARY Multidimensional Fatigue Inventory |
-0.3 | 0.48 |
| SECONDARY Medical Outcomes Study Sleep Scale |
-4.95 | 0.18 |
| SECONDARY Beck Depression Inventory |
-2.31 | 0.03 sig |
Summary
The purpose of the proposed project is to develop and test how well an internet-based behavioral pain self-management program, the Pain EASE program, can be used for treating low back pain in Veterans. Veterans' experiences with usability and satisfaction with the Pain EASE program will also be examined. Behavioral interventions such as exercise and cognitive behavior therapy are known to be effective for low back pain but are often not readily available or easily accessed. Veterans will be able to access the Pain EASE program via their computer with an internet connection, which will increase access to this type of treatment. Study participants will receive 10 weeks of access to the Pain EASE program, which will teach them pain coping skills to manage their low back pain. The primary outcome is pain-related functional interference.
Eligibility Criteria
Inclusion Criteria
- Presence of at least a moderate level of chronic low back pain (i.e., numeric rating scale pain scores of 4) and presence of low back pain for a period of 3 months;
- Availability of a computer with Internet access;
- Indication of the "preparation", "action", or "maintenance" stage of readiness to change on a brief five item staging checklist and a rating of at least 4 or greater on a 0 (not at all interested) to 10 (extremely interested) rating scale designed to ensure participants' interest in receiving pain self-management via the Internet;
- Veteran receiving care at VA Connecticut Healthcare System
Exclusion Criteria
- life threatening or acute medical condition that could impair participation (e.g., severe COPD, lower limb amputation, terminal cancer);
- psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair participation
- surgical interventions for pain during their participation in this study
- sensory deficits that would impair participation (e.g., visual impairment affecting ability to navigate Internet-based intervention).
Data sourced from ClinicalTrials.gov (NCT01918189). 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.