Efficacy of Antidepressants in Chronic Back Pain

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ClinicalTrials.gov Identifier: NCT00964886

Recruitment Status : Completed

First Posted : August 25, 2009

Results First Posted : November 29, 2016

Last Update Posted : November 29, 2016

Sponsor:

Collaborator:

University of California, San Diego

Information provided by (Responsible Party):

VA Office of Research and Development

Study Description

Brief Summary:

This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.

Condition or disease	Intervention/treatment	Phase
Back Pain	Behavioral: cognitive behavioral therapy Drug: desipramine hydrochloride Drug: benztropine mesylate 0.125 mg daily	Phase 2

Detailed Description:

This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	142 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy of Antidepressants in Chronic Back Pain
Study Start Date :	January 2010
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants Back Pain

Drug Information available for: Benztropine mesylate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1 desipramine hydrochloride	Drug: desipramine hydrochloride desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml Other Name: Anafranil
Experimental: Arm 2 cognitive behavioral therapy	Behavioral: cognitive behavioral therapy cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Experimental: Arm 3 desipramine hydrochloride and cognitive behavioral therapy	Drug: desipramine hydrochloride desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml Other Name: Anafranil Behavioral: cognitive behavioral therapy cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Placebo Comparator: Arm 4 anticholinergic medication; active placebo	Drug: benztropine mesylate 0.125 mg daily benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride Other Name: Cogentin

Outcome Measures

Primary Outcome Measures :

Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity [ Time Frame: 12 weeks after baseline (or last observation carried forward) ]
The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.

Secondary Outcome Measures :

Roland and Morris Disability Questionnaire [ Time Frame: 12 weeks after baseline (or last observation carried forward) ]
This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic back pain (daily pain for > 6 months)

Exclusion Criteria:

Major medical conditions which might contraindicate antidepressant treatment

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): NCT00964886

Locations

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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161

Sponsors and Collaborators

VA Office of Research and Development

University of California, San Diego

Investigators

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Principal Investigator:	Joseph H Atkinson, MD	VA San Diego Healthcare System, San Diego, CA

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gould HM, Atkinson JH, Chircop-Rollick T, D'Andrea J, Garfin S, Patel SM, Funk SD, Capparelli EV, Penzien DB, Wallace M, Weickgenanta AL, Slater M, Rutledge T. A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain. 2020 Jun;161(6):1341-1349. doi: 10.1097/j.pain.0000000000001834.

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Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00964886
Other Study ID Numbers:	NURA-019-09S
First Posted:	August 25, 2009 Key Record Dates
Results First Posted:	November 29, 2016
Last Update Posted:	November 29, 2016
Last Verified:	November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Available in SPSS format from the investigators.

Keywords provided by VA Office of Research and Development:


chronic pain back pain antidepressants

Additional relevant MeSH terms:

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Back Pain Pain Neurologic Manifestations Benztropine Desipramine Clomipramine Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Adrenergic Agents	Neurotransmitter Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Dopamine Uptake Inhibitors Dopamine Agents Serotonin Uptake Inhibitors Serotonin Agents

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