ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

Treatment: Drugs

Comparator / control treatment

Benztropine mesylate; 1mg per day; capsule/oral administration; 6 month duration

Control group

Active

Outcomes

Primary outcome [1]

Pain intensity
Measured on the Descriptor Differential Scale (DDS)
Mean pain score
Decrease of 2 units on the DDS

Timepoint [1]

Baseline and 3 and 6 months after intervention commenced

Primary outcome [2]

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]

Baseline and 3 and 6 months after intervention commenced.

Secondary outcome [1]

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]

Baseline and 3 and 6 months after intervention commenced

Secondary outcome [2]

Paid/unpaid work absence and hindrance/productivity measured on Short Form Health and Labour Questionnaire (SFHLQ)

Timepoint [2]

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?

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]

3181

Recruitment postcode(s) [2]

3004

Recruitment postcode(s) [3]

3065

Recruitment postcode(s) [4]

3079

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Hospital

Name [1]

Alfred Research Ethics Committee

Address [1]

Alfred Research Ethics Committee
Alfred Hospital
Commercial Road
Prahran 3181
Vic

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

VU University

Address [1]

VU University
De Boelelaan 1085, room U454
1081 HV Amsterdam

Country [1]

Netherlands

Other collaborator category [2]

Other

Name [2]

National Ageing Research Institute

Address [2]

34/54 Poplar Rd
Parkville
VIC 3052

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Research Ethics Committee

Ethics committee address [1]

55 Commercial Rd, 
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/11/2011

Approval date [1]

23/12/2011

Ethics approval number [1]

HREC/12/Alfred/16, 476/11

Ethics committee name [2]

Eastern Health Human Research Ethics Committee

Ethics committee address [2]

The Office of Research and Ethics
Level 2
5 Arnold Street
Box Hill VIC 3128

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

15/05/2015

Approval date [2]

05/09/2012

Ethics approval number [2]

SERP28/1112

Ethics committee name [3]

Monash University Human Research Ethics Committee

Ethics committee address [3]

Monash University
Level 1, Chancellery Building D, Clayton Campus
26 Sports Walk
Clayton VIC 3800
Australia

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

13/01/2012

Approval date [3]

01/02/2012

Ethics approval number [3]

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

Dr Donna Urquhart

Address

Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

61 3 9903 0555

Fax

Donna.urquhart@monash.edu

Contact person for public queries

Name

Ms Judy Hankin / Ms Alice Noone

Address

Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Alfred Hospital
Commercial Road
Melbourne Vic 3004
Australia

Country

Australia

Phone

+61 3 9903 0553

Fax

+61 3 9903 0556

Judy.Hankin@monash.edu OR Alice.Noone@monash.edu

Contact person for scientific queries

Name

Dr Donna Urquhart or Prof Flavia Cicuttini

Address

Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Alfred Hospital
Commercial Road
Melbourne Vic 3004
Australia

Country

Australia

Phone

+61 3 9903 0555

Fax

+61 3 9903 0556

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

Source	Title	Year of Publication	DOI
Embase	Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial.	2016	https://dx.doi.org/10.1186/s13063-016-1637-1
Embase	Efficacy of Low-Dose Amitriptyline for Chronic Low Back Pain: A Randomized Clinical Trial.	2018	https://dx.doi.org/10.1001/jamainternmed.2018.4222

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically