Telehealth Outreach for Chronic Back Pain
TELE
1 other identifier
interventional
127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Mar 2008
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedResults Posted
Study results publicly available
March 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedFebruary 19, 2018
January 1, 2018
7.8 years
January 22, 2008
February 18, 2015
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study
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.
Baseline, End of Treatment (8 weeks)
Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study
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.
Baseline, End of Treatment for Nurse-Delivered Treatment Study (8 weeks)
Secondary Outcomes (4)
Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study
Baseline, End of Treatment (8 weeks)
Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study
Baseline, End of Treatment of Nurse-Delivered Treatment Study (8 weeks)
Patient-rated Global Clinical Impression of Percent Change in Overall Pain and Function
End of Treatment (8 weeks)
Percentage of Participants Rating Global Impression of Change as 'Much Improved' or 'Very Much Improved'
End of Treatment (8 weeks)
Study Arms (4)
Cognitive Behavioral Therapy-Psychologist-Delivered
EXPERIMENTAL10 hours of Cognitive Behavioral Training delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Supportive Psychotherapy-Psychologist-Delivered
ACTIVE COMPARATOR10 hours of Rogerian Psychotherapy delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Cognitive Behavioral Therapy-Nurse-Delivered
EXPERIMENTAL10 hours of Cognitive Behavioral Training delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Supportive Psychotherapy-Nurse-Delivered
ACTIVE COMPARATOR10 hours of Rogerian Psychotherapy delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Interventions
Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a psychologist
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
Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a nurse
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The small sample size and attrition limits the strength of the evidence.
Results Point of Contact
- Title
- Joseph H. Atkinson MD, Principal Investigator
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph H. Atkinson, MD
VA San Diego Healthcare System, San Diego
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2008
First Posted
February 6, 2008
Study Start
March 1, 2008
Primary Completion
December 31, 2015
Study Completion
December 31, 2015
Last Updated
February 19, 2018
Results First Posted
March 19, 2015
Record last verified: 2018-01