N/A
N=66
Telehealth Outreach for Chronic Back Pain
Pain · Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00608530 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study — 10.0; 10.4; 7.6; 7.8 units on a scale — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy-Psychologist-Delivered (Behavioral); Supportive Psychotherapy-Psychologist-Delivered (Behavioral); Cognitive Behavioral Therapy Nurse-Delivered (Behavioral); Supportive Psychotherapy-Nurse-Delivered (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study |
10.0; 10.4; 7.6; 7.8 | .05 |
| PRIMARY Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study |
11.4; 11.1; 9.4; 9.1 | .05 |
| SECONDARY Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study |
5.0; 5.5; 4.1; 4.1 | >0.05 |
| SECONDARY Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study |
4.9; 5.0; 4.0; 3.8 | — |
| SECONDARY Patient-rated Global Clinical Impression of Percent Change in Overall Pain and Function |
31; 18.5 | .05 |
| SECONDARY Percentage of Participants Rating Global Impression of Change as 'Much Improved' or 'Very Much Improved' |
39; 27 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00608530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.