Status:
COMPLETED
Telehealth Outreach for Chronic Back Pain
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of California, San Diego
Conditions:
Pain
Back Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 batterie...
Detailed Description
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 discharg...
Eligibility Criteria
Inclusion
- Ages 18-75 inclusive;
- chronic musculoskeletal low back pain (pain "on a daily basis" for at least six months) as the primary pain problem;
- not eligible for back surgery;
- presently lives in the San Diego area and will do so six months after baseline examination;
- English-speaking, literate, with stable residence and phone.
Exclusion
- 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);
- candidate for spine surgery;
- 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;
- history of Diagnostic and Statistical Manual (DSM)-IV bipolar disorder, dementia, or schizophrenia;
- current active DSM-IV diagnosed alcohol or non-prescribed substance dependence;
- current active DSM-IV major depressive episode or post-traumatic stress disorder since specialty mental health care would be indicated;
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00608530
Start Date
March 1 2008
End Date
December 31 2015
Last Update
February 19 2018
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161