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Trial registered on ANZCTR


Registration number
ACTRN12612000131853
Ethics application status
Approved
Date submitted
25/01/2012
Date registered
30/01/2012
Date last updated
9/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Is amitriptyline effective in the management of chronic low back pain?
Scientific title
Is low dose amitriptyline more effective than an active placebo in the management of chronic low back pain? A double-blind, randomized, placebo-controlled trial.
Secondary ID [1] 279751 0
None
Universal Trial Number (UTN)
U1111-1127-3216
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 285612 0
Condition category
Condition code
Musculoskeletal 285804 285804 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low-dose amitriptyline; 25mg per day; capsule/oral administration; 6 month duration
Intervention code [1] 284119 0
Treatment: Drugs
Comparator / control treatment
Benztropine mesylate; 1mg per day; capsule/oral administration; 6 month duration
Control group
Active

Outcomes
Primary outcome [1] 286318 0
Pain intensity
Measured on the Descriptor Differential Scale (DDS)
Mean pain score
Decrease of 2 units on the DDS
Timepoint [1] 286318 0
Baseline and 3 and 6 months after intervention commenced
Primary outcome [2] 303609 0
Pain intensity measured on the visual analog scale (VAS, 0-100)
Mean pain score
Minimally clinically important difference: Improvement of 15 points on the VAS
Timepoint [2] 303609 0
Baseline and 3 and 6 months after intervention commenced.
Secondary outcome [1] 295598 0
Functional status measured on the Roland Morris Disability Questionnaire (RMDQ);
Mean Disability Score;
Minimally clinically important difference: Improvement of 13-16% in disability or 3-4 points on RMDQ.
Timepoint [1] 295598 0
Baseline and 3 and 6 months after intervention commenced
Secondary outcome [2] 295747 0
Paid/unpaid work absence and hindrance/productivity measured on Short Form Health and Labour Questionnaire (SFHLQ)
Timepoint [2] 295747 0
Baseline and each month for 6 months after intervention commenced

Eligibility
Key inclusion criteria
1. Aged 18-75 years
2. Chronic low back pain (Chronic > 3 months in duration; pain in the region bordered above by the costal margin and below by the gluteal folds)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Specific pathological entities, such as infection, metastasis, osteoporosis, fractures.
- Major co-existing illness which might confound assessment of function or for which amitriptyline may be inappropriate
- Another significant musculoskeletal conditions
- History of psychosis
- Patients with any diagnosed depression with or without the use of medication
- Any prior or current use of antidepressants
- Current use of opioids
- Any contra-indication or allergy to amitriptyline
- Pregnancy or planning/trying to become pregnant or breastfeeding
- Inability to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be ensured by the use of identical, active placebo, and the use of a central
automated allocation procedure, with security in place to ensure allocation data cannot be accessed
or influenced by any person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be based on computer generated random numbers prepared by a statistician who had no involvement in conducting the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2012
Actual
30/04/2012
Date of last participant enrolment
Anticipated
Actual
1/11/2015
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
150
Accrual to date
Final
146
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 4878 0
3004
Recruitment postcode(s) [2] 4879 0
3065
Recruitment postcode(s) [3] 4880 0
3079
Recruitment postcode(s) [4] 4865 0
3181

Funding & Sponsors
Funding source category [1] 284538 0
Government body
Name [1] 284538 0
National Health and Medical Research Council
Country [1] 284538 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Alfred Hospital
Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 283467 0
Hospital
Name [1] 283467 0
Alfred Research Ethics Committee
Address [1] 283467 0
Alfred Research Ethics Committee
Alfred Hospital
Commercial Road
Prahran 3181
Vic
Country [1] 283467 0
Australia
Other collaborator category [1] 260463 0
University
Name [1] 260463 0
VU University
Address [1] 260463 0
VU University
De Boelelaan 1085, room U454
1081 HV Amsterdam
Country [1] 260463 0
Netherlands
Other collaborator category [2] 260476 0
Other
Name [2] 260476 0
National Ageing Research Institute
Address [2] 260476 0
34/54 Poplar Rd
Parkville
VIC 3052
Country [2] 260476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286524 0
Alfred Research Ethics Committee
Ethics committee address [1] 286524 0
55 Commercial Rd,
Melbourne VIC 3004
Ethics committee country [1] 286524 0
Australia
Date submitted for ethics approval [1] 286524 0
25/11/2011
Approval date [1] 286524 0
23/12/2011
Ethics approval number [1] 286524 0
HREC/12/Alfred/16, 476/11
Ethics committee name [2] 298788 0
Eastern Health Human Research Ethics Committee
Ethics committee address [2] 298788 0
The Office of Research and Ethics
Level 2
5 Arnold Street
Box Hill VIC 3128
Ethics committee country [2] 298788 0
Australia
Date submitted for ethics approval [2] 298788 0
15/05/2015
Approval date [2] 298788 0
05/09/2012
Ethics approval number [2] 298788 0
SERP28/1112
Ethics committee name [3] 298789 0
Monash University Human Research Ethics Committee
Ethics committee address [3] 298789 0
Monash University
Level 1, Chancellery Building D, Clayton Campus
26 Sports Walk
Clayton VIC 3800
Australia
Ethics committee country [3] 298789 0
Australia
Date submitted for ethics approval [3] 298789 0
13/01/2012
Approval date [3] 298789 0
01/02/2012
Ethics approval number [3] 298789 0
CF12/0271 - 2012000106

Summary
Brief summary
Chronic low back pain is a major public health problem. Antidepressants are one commonly prescribed treatment for low back pain, and are used not only to treat depression and insomnia, but chronic pain. Their use is rapidly increasing, despite lack of supportive evidence and conflicting recommendations from clinical guidelines.

Aims: In community-based adults with chronic low back pain, we aim to determine:
1. If low dose amitriptyline (tricyclic antidepressant) is more effective than an active placebo in the management of pain
2. If low dose amitriptyline is more effective than an active placebo in improving disability and reducing work absence and hindrance.

Methods: A double-blind, randomized, placebo-controlled trial will be conducted. We will recruit 150 subjects with chronic low back pain. Participants will receive low-dose amitriptyline or an active placebo for 6 months. Pain, disability and work absence and hindrance will be assessed at baseline, 3 and 6 months using valid measures.

Implications: If antidepressants are found to be effective, it will provide high quality evidence for their use, potentially enabling this treatment option to be considered by more individuals with chronic low back pain. If we do not find antidepressants to be effective, then this trial will provide strong evidence to review international guidelines that recommend their use and to evaluate the extensive use of tricyclic antidepressants for chronic low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33650 0
Dr Donna Urquhart
Address 33650 0
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 33650 0
Australia
Phone 33650 0
61 3 9903 0555
Fax 33650 0
Email 33650 0
Donna.urquhart@monash.edu
Contact person for public queries
Name 16897 0
Ms Ms Judy Hankin / Ms Alice Noone
Address 16897 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Alfred Hospital
Commercial Road
Melbourne Vic 3004
Australia
Country 16897 0
Australia
Phone 16897 0
+61 3 9903 0553
Fax 16897 0
+61 3 9903 0556
Email 16897 0
Judy.Hankin@monash.edu OR Alice.Noone@monash.edu
Contact person for scientific queries
Name 7825 0
Prof Dr Donna Urquhart or Prof Flavia Cicuttini
Address 7825 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Alfred Hospital
Commercial Road
Melbourne Vic 3004
Australia
Country 7825 0
Australia
Phone 7825 0
+61 3 9903 0555
Fax 7825 0
+61 3 9903 0556
Email 7825 0
Donna.Urquhart@monash.edu OR Flavia.Cicuttini@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of Low-Dose Amitriptyline for Chronic Low Back Pain: A Randomized Clinical Trial.2018https://dx.doi.org/10.1001/jamainternmed.2018.4222
EmbaseIs low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1637-1
N.B. These documents automatically identified may not have been verified by the study sponsor.