| Title |
Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial
|
|---|---|
| Published in |
Trials, October 2016
|
| DOI | 10.1186/s13063-016-1637-1 |
| Pubmed ID | |
| Authors |
Donna M. Urquhart, Anita E. Wluka, Malcolm R. Sim, Maurits van Tulder, Andrew Forbes, Stephen J. Gibson, Carolyn Arnold, Chris Fong, Shane N. Anthony, Flavia M. Cicuttini |
| Abstract |
Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low-dose antidepressants are commonly used to treat pain in chronic low back pain. However, their efficacy is unproven. The aim of this pragmatic, double-blind, randomised, placebo-controlled trial is to determine whether low-dose amitriptyline (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic low back pain. One hundred and fifty individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics, advertising in local media and posting of flyers in community locations. They will be randomly allocated to receive either low-dose amitriptyline (25 mg) or an active placebo (benztropine mesylate, 1 mg) for 6 months. The primary outcome measure of pain intensity will be assessed at baseline, 3 and 6 months using validated questionnaires. Secondary measures of self-reported low back disability, work absence and hindrance in the performance of paid/unpaid work will also be examined. Intention-to-treat analyses will be performed. This pragmatic, double-blind, randomised, placebo-controlled trial will provide evidence regarding the effectiveness of low-dose antidepressants compared with placebo in reducing pain, disability, work absenteeism and hindrance in work performance in individuals with chronic low back pain. This trial has major public health and clinical importance as it has the potential to provide an effective approach to the management of chronic low back pain. Australian New Zealand Clinical Trials Registry: ACTRN12612000131853 ; registered on 30 January 2012. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 91 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 91 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 13 | 14% |
| Researcher | 12 | 13% |
| Student > Ph. D. Student | 5 | 5% |
| Student > Doctoral Student | 5 | 5% |
| Student > Bachelor | 5 | 5% |
| Other | 19 | 21% |
| Unknown | 32 | 35% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 19 | 21% |
| Nursing and Health Professions | 11 | 12% |
| Social Sciences | 4 | 4% |
| Psychology | 4 | 4% |
| Sports and Recreations | 3 | 3% |
| Other | 13 | 14% |
| Unknown | 37 | 41% |