Viewing Study NCT01918189



Ignite Creation Date: 2024-05-06 @ 1:52 AM
Last Modification Date: 2024-10-26 @ 11:11 AM
Study NCT ID: NCT01918189
Status: COMPLETED
Last Update Posted: 2019-11-18
First Post: 2013-08-02

Brief Title: Internet-based Behavioral Pain Management
Sponsor: VA Office of Research and Development
Organization: VA Office of Research and Development

Study Overview

Official Title: Development of an Internet-based Behavioral Pain Management Intervention
Status: COMPLETED
Status Verified Date: 2019-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: OBJECTIVES The primary objectives of the proposed study are to 1 develop an integrative Internet-based Veteran-centered behavioral intervention the Pain EASE program for chronic low back pain CLBP and 2 examine preliminary efficacy usability and satisfaction of this intervention in a representative sample of Veterans with CLBP The primary hypothesis states that a clinically meaningful reduction in pain-related functional interference will be observed following ten weeks of exposure to the Pain EASE program relative to baseline The secondary hypotheses state that clinically meaningful reductions in ratings of average pain intensity on a 0 no pain to 10 worst pain imaginable numeric rating scale at the ten week post-baseline follow-up assessment interval will be observed in addition to statistically significant reductions in fatigue sleep problems depressive symptoms and negative mood at the ten week post-baseline assessment The tertiary hypotheses state that participants will report high levels of interest site usage and satisfaction

RESEARCH DESIGN A non-randomized pilot study with two phases is proposed to develop and evaluate an internet-based behavioral pain self-management program Phase I will solely involve qualitative data collection Repeated quantitative assessments during Phase II will be conducted at baseline and 10-weeks post-baseline

METHODOLOGY A 24-month pilot study with two phases is proposed During Phase I the Pain EASE program will be developed and feedback from 15 Veterans with CLBP and an Expert Panel of pain management clinicians will be used to modify the program During Phase II a pilot feasibility trial of the Pain EASE program with 55 Veterans with CLBP will be conducted Subjects will be a total of 70 patients receiving care at the VA Connecticut Healthcare System VACHS who report chronic low back pain The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain ie scores of 4 or greater on a 0 no pain to 10 worst pain imaginable on a numerical rating scale of pain and indication of the preparation action or maintenance stage of readiness to change on a brief five item staging checklist All patients must have access to a computer with an internet connection Excluded will be patients with life threatening or acute physical illness current alcohol or substance abuse or dependence current psychosis suicidal ideation dementia and individuals seeking surgical pain treatment All participants will continue to receive their usual care from Veterans Health Administration VHA providers During the 10-week therapeutic window weekly telephone calls from research staff will serve to cue and monitor participants use of the Internet program At ten weeks post-baseline participants will be formally reassessed Primary and secondary hypotheses involving quantitative data will be analyzed using an intent-to-treat principle and will employ t-tests and non-parametric analogs and regression analyses

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None