Internet-based Behavioral Pain Management

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 (i.e., 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.

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).