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Telehealth Outreach for Chronic Back Pain (TELE)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 6, 2008
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
University of California, San Diego
Information provided by (Responsible Party):
VA Office of Research and Development
This double blind, randomized, parallel groups, two arm, six month clinical trial. Patients will have chronic low back pain of non-neoplastic origin. Patients will be randomized to one of two conditions, either Cognitive Behavioral Training or Rogerian psychotherapy; both conditions are home-based, telephone supported, with 10 hours of contact time delivered over 8 weeks.

Condition Intervention Phase
Pain Back Pain Behavioral: Cognitive behavioral therapy Behavioral: Rogerian psychotherapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth Outreach for Chronic Back Pain

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Roland and Morris Disability Questionnaire [ Time Frame: Baseline, End of Treatment (8 weeks) ]
    The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.

Secondary Outcome Measures:
  • Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) [ Time Frame: Baseline, End of Treatment (8weeks) ]
    The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from "0" to "1 0" where "0" indicates "no pain" and "10" indicates the "worst imaginable pain."

  • Percentage of Participants With at Least 25% Improvement on Global Impression of Change [ Time Frame: End of Treatment (8 weeks) ]
    Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as "Improved," "No change," or "Worse." Participants rating themselves as "Improved" were asked to estimate percentage of improvement (i.e., 1 to 100%). Percentage of participants with at least 25% improvement were compared between treatment groups.

Enrollment: 66
Study Start Date: March 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Behavioral: Cognitive behavioral therapy
Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
Active Comparator: Supportive Psychotherapy
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Behavioral: Rogerian psychotherapy
Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach

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 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 specialists. 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 Cogntive Behavioral Self-Managment Skills Training (CBSST) program appears to be effective in reducing disability and pain, and improving mood in chronic back pain.

We propose a double blind, randomized assignment, two-arm, parallel groups, six month clinical trial. Patients with CLBP will be recruited from VA San Diego primary care clinics and the community. Subjects will receive either CBSST (N = 65) or Rogerian Psychotherapy (N=65) in a home-based, telephone delivered format for a total of 10 hours of therapist contact time. Assessments will be conducted at baseline and at end of treatment, and at one, three and six months post-treatment. The primary data analytic strategy will be an intent-to-treat analysis (last observation carried forward) of all participants as randomized. The primary end point will be physical function (Roland & Morris Disability) at end of 8-week treatment; secondary end points will be pain intensity (Numeric Rating Scale) and patient-reported clinical global impression of change. Supplemental analyses will be conducted to test for durability of therapeutic effect at one, three, and six month post-treatment. Rigorously controlled clinical trials of the type we propose could contribute to more effective and more cost-efficient back pain treatment.

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608530

United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
University of California, San Diego
Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00608530     History of Changes
Other Study ID Numbers: B4767-I
First Submitted: January 22, 2008
First Posted: February 6, 2008
Results First Submitted: February 18, 2015
Results First Posted: March 19, 2015
Last Update Posted: March 19, 2015
Last Verified: February 2015

Keywords provided by VA Office of Research and Development:
chronic pain
chronic back pain
randomized clinical trial

Additional relevant MeSH terms:
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms