Low Back Pain | Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
Low Back Pain research study
What is the primary objective of this study?
Chronic low back pain (CLBP) is one of the most frequent forms of chronic pain and can result in significant functional impairment. This is often associated with major depression too. Previous research reported significant beneficial effects of antidepressant medication in alleviating depression and pain intensity. The aim of this study is to evaluate the efficacy of Escitalopram, a new kind of Selective Serotonin Reuptake Inhibitor (SSRI) in patients with CLBP in a prospective, randomized and double-blind clinical trial. The main hypothesis is: -in comparison to placebo, subjects with CLBP and Cipralex report a significant reduction in depressive symptoms (>= 50% of HAMD questionnaire) after 4 weeks of treatment.
Who is eligible to participate?
Inclusion Criteria: - In- and out-patients at KH Bethanien, Greifswald, presenting with non-specific chronic low back pain lasting longer than 6 months (assessed with VAS and OLBPQ rev.) - Age from 18 to 65 years - Depressive symptoms (HAMD scores >10) - Significant disability in daily living tasks (Owestry Disability Index >30%) - Medication with nonsteroidal anti-inflammatory drugs. Exclusion Criteria: - Other significant Axis I disorders, including psychosis, eating disorders, substance use disorders or recent suicidal behavior. - Systemic inflammatory disorder, malignancy, other acute medical or neurological disorders, recent surgery within 12 months. - Medication with opioids, corticosteroids, other psychotropic medication except Temazepam. - History of gastric ulcer, gastritis or gastric bleeding. - Known allergy or intolerance to Citalopram or Cipralex. - Pregnant or lactating women.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Low Back Pain
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:EscitalopramEscitalopram 10mg per day for the first week, then 20mg per day till the end of study.
Drug:PlaceboPlacebo 10mg per day for the first week, then 20mg per day till the end of study.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
A, 2, IIPlacebo 10mg per day for the first week, then 20mg per day till the end of study.
A, 1Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
Start Date: November 2007
Completed Date: November 2012
Phase: Phase 4
Primary Outcome: In comparison to placebo-treated patients, patients with treated with Cipralex report a significant reduction in depressive symptoms (>= 50% HAMD score) after 4 weeks of treatment.
Secondary Outcome: In comparison to placebo, subjects treated with Cipralex report a significant reduction in pain intensity (>= 50% reduction of pain questionnaire score or VAS) after 12 weeks of treatment.
Study sponsors, principal investigator, and references
Principal Investigator: Ulrich W Preuss, MD
Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg
Dickens C, Jayson M, Sutton C, Creed F. The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain. Psychosomatics. 2000 Nov-Dec;41(6):490-9.
Atkinson JH, Slater MA, Wahlgren DR, Williams RA, Zisook S, Pruitt SD, Epping-Jordan JE, Patterson TL, Grant I, Abramson I, Garfin SR. Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain. 1999 Nov;83(2):137-45.