Telehealth Outreach for Chronic Back Pain



Status:Completed
Conditions:Back Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 75
Updated:1/19/2018
Start Date:March 2008
End Date:December 31, 2015

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Two separate double double blind, randomized, parallel groups, two-arm, 8 week clinical
trials with 6-moth follow-up were conducted using identical inclusion/exclusion criteria and
assessment batteries. In both studies patients had chronic low back pain of non-neoplastic
origin. In both studies patients were randomized to one of two conditions, either a Cognitive
Behavioral-based Therapy or a control condition, a supportive (Rogerian) psychotherapy. Both
the cognitive-behavioral and supportive psychotherapy conditions consisted of home-based,
telephone supported treatment, with 10 hours of contact time delivered over 8 weeks. In the
first study (Study 1) the behavioral and Rogerian interventions were delivered by a licensed
psychologist. In the second (Study 2) the interventions were delivered by a medical primary
care nurse.

Chronic low back pain (CLBP) is a major medical problem for the VA, affecting up to 15% of
all veterans in primary care. Furthermore, prior surveys indicate CLBP is a leading cause of
medical discharge of active duty personnel, and of medical disability costs. Given current
demands on military personnel it is likely the burden of chronic pain will increase. The VA
has adopted the Agency for Health Care Policy and Research Guidelines for evaluation of back
pain but these guidelines do not provide specifics for true rehabilitation. It is
acknowledged that most back pain patients are not surgical candidates, that medications
provide only limited analgesia, and that symptom control and improved function require a
comprehensive approach addressing the cognitive, affective, and behavioral aspects of chronic
pain. Fortunately, structured, specific interventions to both address the multidimensional
nature of pain and operationalize treatment principles in primary care settings are
available. These interventions, which reflect the VA emphasis on patient-centered care, can
be effective in reducing disability and pain, but are a frequently overlooked component of
effective care. One reason is that most clinics lack appropriately trained psychologists.
Moreover, even when specialists are available, the prevailing clinic-based service model is
either too resource-intensive, or presents barriers to access.

One approach to addressing some these barriers is the use of "telehealth" outreach. Studies
in diverse medical disorders and some chronic pain syndromes suggest that care can be
delivered efficiently and effectively with minimal therapist contact in home-based treatment
models, using telephone consultation to replace clinic visits. These approaches are fully
congruent with recent VA telehealth initiatives to improve access and cost efficiency. In VA
Pain Clinic settings our face-to-face, 8-week, 8-hours contact time Cognitive Behavioral
Self-Management Skills Training (CBSST) program appears to be effective in reducing
disability and pain, and improving mood in chronic back pain. Given the scarcity of
specialized psychologists, a second approach is to train non-specialists (eg, primary care
medical nurse personnel) instead of psychologists to deliver treatment, to help improve
access to the intervention.

We conducted two double blind, randomized assignment, two-arm, parallel groups, six-month
clinical trials. Patients with CLBP were recruited from VA San Diego primary care clinics and
the community. Participants received either CBSST or Rogerian Psychotherapy in a home-based,
telephone- delivered format for a total of 10 hours of therapist contact time. The
methodological difference between the two studies was the discipline of the interventionist.
In Study 1 the intervention was delivered by a psychologist with specific training in
cognitive behavioral therapy; in Study 2 the intervention was was done by a medical primary
care nurse who had been trained to deliver a version of CBSST modified to be suitable for
delivery by an individual without specific expertise in cognitive behavioral therapy. The
control condition was a supportive psychotherapy, again suitably modified in the case of the
medical nurse interventionist. Assessments were conducted at baseline and at end of
treatment, and at one, three and six months post-treatment. The primary data analytic
strategy was an intent-to-treat analysis (last observation carried forward) of all
participants as randomized. The primary end point was physical function (Roland & Morris
Disability) at end of 8-week treatment; secondary end points were pain intensity (Numeric
Rating Scale) and patient-reported clinical global impression of change. The aim of the
research was to develop more accessible and more cost-efficient back pain treatment.

Key Words: Back Pain, Cognitive-Behavioral Treatment, Clinical Trial

Inclusion Criteria:

1. Ages 18-75 inclusive;

2. chronic musculoskeletal low back pain (pain "on a daily basis" for at least six
months) as the primary pain problem;

3. not eligible for back surgery;

4. presently lives in the San Diego area and will do so six months after baseline
examination;

5. English-speaking, literate, with stable residence and phone.

Exclusion Criteria:

1. Major medical illness (e.g., insulin-dependent diabetes mellitus with neuropathy or
"poor control", heart disease with New York Heart Association Functional Class III or
IV, or chronic obstructive pulmonary disease requiring supplemental oxygen which might
confound effects of pain on function);

2. candidate for spine surgery;

3. back pain associated with pregnancy, rheumatoid arthritis, neoplastic disease,
osteomyelitis, or neural arch lesions, since their treatment and prognosis differs
from the usual back pain population, or spinal stenosis, since increased physical
activity would be contraindicated;

4. history of Diagnostic and Statistical Manual (DSM)-IV bipolar disorder, dementia, or
schizophrenia;

5. current active DSM-IV diagnosed alcohol or non-prescribed substance dependence;

6. current active DSM-IV major depressive episode or post-traumatic stress disorder since
specialty mental health care would be indicated;

7. non-opioid and opioid analgesics are permitted, except we will exclude patients on a
hospital-initiated opioid treatment "contract," since at this medical center
"contracting" identifies patients with history of opioid diversion, multiple VA and
non-VA opioid prescribers, and repeated dose escalation in the absence of evidence of
disease progression.
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