TY - JOUR
T1 - Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain
T2 - Protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial
AU - Cherkin, Daniel C.
AU - Sherman, Karen J.
AU - Balderson, Benjamin H.
AU - Turner, Judith A.
AU - Cook, Andrea J.
AU - Stoelb, Brenda
AU - Herman, Patricia M.
AU - Deyo, Richard A.
AU - Hawkes, Rene J.
N1 - Funding Information:
The National Center for Complementary and Alternative Medicine (NCCAM) provided funding for this trial (grant R01 AT006226). The design of this trial was reviewed and approved by NCCAM’s Office of Clinical and Regulatory Affairs.
PY - 2014/6/7
Y1 - 2014/6/7
N2 - Background: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. Methods/Design: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. Discussion: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. Trial registration: Clinicaltrials.gov Identifier: NCT01467843.
AB - Background: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. Methods/Design: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. Discussion: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. Trial registration: Clinicaltrials.gov Identifier: NCT01467843.
KW - Back pain
KW - Cognitive-behavioral therapy
KW - Mindfulness meditation
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U2 - 10.1186/1745-6215-15-211
DO - 10.1186/1745-6215-15-211
M3 - Article
C2 - 24906419
AN - SCOPUS:84902252540
SN - 1745-6215
VL - 15
JO - Trials
JF - Trials
IS - 1
M1 - 211
ER -