Tags

Type your tag names separated by a space and hit enter

A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain.
Pain. 2020 06; 161(6):1341-1349.PAIN

Abstract

This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain.

Authors+Show Affiliations

VA San Diego Healthcare System, San Diego, CA, United States. University of California, San Diego, CA, United States.VA San Diego Healthcare System, San Diego, CA, United States. University of California, San Diego, CA, United States.University of California, San Diego, CA, United States.VA San Diego Healthcare System, San Diego, CA, United States. University of California, San Diego, CA, United States.University of California, San Diego, CA, United States.VA San Diego Healthcare System, San Diego, CA, United States.VA San Diego Healthcare System, San Diego, CA, United States.University of California, San Diego, CA, United States.Wake Forest School of Medicine, Winston Salem, NC, United States.University of California, San Diego, CA, United States.No affiliation info availableHonorHealth Research Institute, Scottsdale, AZ, United States.VA San Diego Healthcare System, San Diego, CA, United States. University of California, San Diego, CA, United States.

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

32068667

Citation

Gould, Hilary M., et al. "A Randomized Placebo-controlled Trial of Desipramine, Cognitive Behavioral Therapy, and Active Placebo Therapy for Low Back Pain." Pain, vol. 161, no. 6, 2020, pp. 1341-1349.
Gould HM, Atkinson JH, Chircop-Rollick T, et al. A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain. 2020;161(6):1341-1349.
Gould, H. M., Atkinson, J. H., Chircop-Rollick, T., DʼAndrea, J., Garfin, S., Patel, S. M., Funk, S. D., Capparelli, E. V., Penzien, D. B., Wallace, M., Weickgenanta, A. L., Slater, M., & Rutledge, T. (2020). A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain, 161(6), 1341-1349. https://doi.org/10.1097/j.pain.0000000000001834
Gould HM, et al. A Randomized Placebo-controlled Trial of Desipramine, Cognitive Behavioral Therapy, and Active Placebo Therapy for Low Back Pain. Pain. 2020;161(6):1341-1349. PubMed PMID: 32068667.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. AU - Gould,Hilary M, AU - Atkinson,Joseph Hampton, AU - Chircop-Rollick,Tatiana, AU - DʼAndrea,John, AU - Garfin,Steven, AU - Patel,Shetal M, AU - Funk,Stephen D, AU - Capparelli,Edmund V, AU - Penzien,Donald B, AU - Wallace,Mark, AU - Weickgenanta,Anne L, AU - Slater,Mark, AU - Rutledge,Thomas, PY - 2020/2/19/pubmed PY - 2020/2/19/medline PY - 2020/2/19/entrez SP - 1341 EP - 1349 JF - Pain JO - Pain VL - 161 IS - 6 N2 - This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain. SN - 1872-6623 UR - https://www.unboundmedicine.com/medline/citation/32068667/A_randomized_placebo-controlled_trial_of_desipramine,_cognitive_behavioral_therapy,_and_active_placebo_therapy_for_low_back_pain L2 - https://doi.org/10.1097/j.pain.0000000000001834 DB - PRIME DP - Unbound Medicine ER -