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Telehealth Outreach for Chronic Back Pain (TELE)

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ClinicalTrials.gov Identifier: NCT00608530
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : March 19, 2015
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease Intervention/treatment
Pain Back Pain Behavioral: Cognitive Behavioral Therapy-Psychologist-Delivered Behavioral: Supportive Psychotherapy-Psychologist-Delivered Behavioral: Cognitive Behavioral Therapy Nurse-Delivered Behavioral: Supportive Psychotherapy-Nurse-Delivered

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 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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth Outreach for Chronic Back Pain
Study Start Date : March 2008
Primary Completion Date : December 31, 2015
Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy-Psychologist-Delivered
10 hours of Cognitive Behavioral Training delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Behavioral: Cognitive Behavioral Therapy-Psychologist-Delivered
Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a psychologist
Active Comparator: Supportive Psychotherapy-Psychologist-Delivered
10 hours of Rogerian Psychotherapy delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Behavioral: Supportive Psychotherapy-Psychologist-Delivered
Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was administered by a psychologist
Experimental: Cognitive Behavioral Therapy-Nurse-Delivered
10 hours of Cognitive Behavioral Training delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Behavioral: Cognitive Behavioral Therapy Nurse-Delivered
Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a nurse
Active Comparator: Supportive Psychotherapy-Nurse-Delivered
10 hours of Rogerian Psychotherapy delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Behavioral: Supportive Psychotherapy-Nurse-Delivered
Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian Therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was delivered by a nurse


Outcome Measures

Primary Outcome Measures :
  1. Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study [ 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.

  2. Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study [ Time Frame: Baseline, End of Treatment for Nurse-Delivered Treatment Study (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 :
  1. Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study [ Time Frame: Baseline, End of Treatment (8 weeks) ]
    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."

  2. Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study [ Time Frame: Baseline, End of Treatment of Nurse-Delivered Treatment Study (8 weeks) ]
    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."

  3. Patient-rated Global Clinical Impression of Percent Change in Overall Pain and Function [ 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 "Better," "Worse," or "About the Same." Participants then were asked to estimate the percentage of change (i.e., 0 to 100%). Participants rating themselves as "About the Same" were coded as "0%" change. The percentage of change was calculated for each Group as a whole (Cognitive Behavioral Therapy-Psychologist Delivered compared to Supportive Care Psychologist-Delivered).

  4. Percentage of Participants Rating Global Impression of Change as 'Much Improved' or 'Very Much Improved' [ Time Frame: End of Treatment (8 weeks) ]
    Participant self-rating of overall change compared to baseline, considering overall function and pain intensity, using a 7-point scale ranging from 'Very Much Worse' to 'Very Much Improved.' We compared the proportion of participants in each Group rating themselves as either 'Much Improved' or 'Very Much Improved.'


Eligibility Criteria

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
Criteria

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


Locations
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
Investigators
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 Posted: February 6, 2008    Key Record Dates
Results First Posted: March 19, 2015
Last Update Posted: January 17, 2018
Last Verified: January 2018

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

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