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Trial registered on ANZCTR

Registration number

ACTRN12612000354886

Ethics application status

Approved

Date submitted

26/03/2012

Date registered

28/03/2012

Date last updated

1/08/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Benztropine for the relief of acute non-traumatic neck pain – a randomised trial

Scientific title

In patients presenting to the emergency department with acute non-traumatic neck pain, does benztropine compared to placebo relieve pain

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1129-4947

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute non-traumatic neck pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

a single dose of 2mg by intra-muscular injection (IM) of benztropine (volume of 2ml) will be administered.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

2ml of IM normal saline

Control group

Placebo

Outcomes

Primary outcome [1]

The mean change in pain scores will be compared between the two groups, as measured by the treating doctor using the verbal numeric rating scale. With the verbal numeric rating scale the patient will be asked to score their pain from 0 to 10 with 0 indicating no pain, and 10 indicating the worst pain imaginable.

Timepoint [1]

Time 0 and at time 30 minutes after the injection

Secondary outcome [1]

Range of neck motion in 4 directions in degrees: flexion, extension, rotation to left, rotation to right. Measurement will be done with a universal goniometer.

Timepoint [1]

Time 0 and at time 30 minutes after the injection

Eligibility

Key inclusion criteria

-Non-traumatic neck pain of <24 hours duration
-Age 16-65

Minimum age

16 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-Use of drugs known to cause dystonic reactions in the 24 hours prior to the onset of pain (eg metoclopramide (maxalon), prochlorperazine (stemetil), promethazine (phenergan), haloperidol)
-Clinical suspicion of a secondary cause for pain (eg neck-space infections, cervical osteomyelitis, discitis, epidural abscess, pathological cervical fractures, primary or secondary malignancies)
-Past history of cervical spine fracture
-Past history of chronic or recurrent neck pain
-Past history of cervical spine surgery
-Fever
-Focal neurological deficit
-Known allergy or adverse event to benztropine
-Anti-coagulant medication (eg warfarin or enoxaparin) or clopidogrel
-Known coagulation disorder (eg haemophilia) or platelet disorder (eg ITP, leukaemia, myelodysplastic disorder)
-Parkinsons disease
-Schizophrenia
-Pregnant women

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)

The treating doctor will order the medication to be given by writing on a medication chart “benztropine or placebo 2ml IM. The medication chart will be given to the emergency department 'team co-ordinator'. Randomisation will then occur by opening sequentially numbered envelopes which are sealed and opaque in which the study allocation has been randomly assigned. These envelopes will be stored with the 'team co-ordinator'. Also, sealed inside will be a data collection sheet. The envelope will be opened by the ‘team co-ordinator’ who will then draw up the appropriate study drug. The team co-ordinator will then give the study drug to the nurse looking after the participant, and the data collection sheet to the doctor looking after the participant. The team co-ordinator will not divulge the contents of the syringe. Instructions in the envelope will re-enforce to the team co-ordinator not to divulge the contents of the syringe. While it would be ideal to have benztropine and saline in matching vials labelled A or B, funding constraints make this option unavailable. The team co-ordinator has been chosen as the person to draw up the study drug as they work in an area of ED physically distant from the clinic/consulting area where participants will be enrolled and treated. This means that the doctor, nurse and patient will be physically distant from the 'team co-ordinator' minimising the chance of accidental un-blinding. This method has been successfully used previously in this emergency department for a clinical trial.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation sequence was computer generate utilising block randomisation methods to ensure balanced numbers in each group.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2012

Actual

1/05/2012

Date of last participant enrolment

Anticipated

Actual

1/07/2014

Date of last data collection

Anticipated

Actual

1/07/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2217

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

St George Hospital

Address

Gray St
Kogarah
NSW, 2217

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Central Coast Area Health Service Human Research Ethics Committee (Harbour)

Ethics committee address [1]

Royal North Shore Hospital
Reserve Road, St Leonards, NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/06/2011

Approval date [1]

22/09/2011

Ethics approval number [1]

HREC/11/HAWKE/145

Summary

Brief summary

Patients present to the Emergency department with acute cervical muscle spasm and pain, which may be spontaneous in onset or related to non-traumatic twisting events. In lay speech this may be referred to as a ‘wry neck’. Conventional analgesics such as paracetamol, NSAIDs and oral opoids are the mainstay of treatment for wry neck, but often provide inadequate pain relief. Centrally acting anti-cholinergic drugs are used for the relief of pain/spasm from the chronic condition of idiopathic cervical dystonia and from drug induced dystonic reactions. The use of these drugs for acute spasmodic neck pain has been poorly studied. There is a single study in the literature assessing the centrally-acting anti-cholinergic drug benztropine (trade name cogentin) in the relief of pain and spasm from this condition. This is a case series of 5 patients with acute pain and spasm of the neck and demonstrated remarkable relief of pain and improvement in range of motion in all patients following an intra-muscular injection of benztropine.
Our hypothesis is that IM benztropine will provide relief of neck pain and improve range of neck movement in patients presenting with wry neck. We aim to compare the effect of 2mg IM benztropine with placebo on pain scores and range of motion in patients presenting to the ED with wry neck.

Trial website

Trial related presentations / publications

Asha SE, Kerr A, Jones K, McAlpine A. Benztropine for the relief of acute non-traumatic neck pain (wry neck) – a randomised trial. Emergency medicine journal. Published Online First, 20 November 2014: doi:10.1136/emermed-2014-204317

Public notes

Contacts

Principal investigator

Name

Dr Stephen Asha

Address

Emergency Department, St George Hospital Gray St, Kogarah, NSW, 2217

Country

Australia

Phone

+61 2 9113 1650

Fax

+61 2 9113 3946

[email protected]

Contact person for public queries

Name

Dr Stephen Asha

Address

Emergency Department, St George Hospital
Gray St, Kogarah, NSW, 2217

Country

Australia

Phone

+61 2 9113 1650

Fax

+61 2 9113 3946

[email protected]

Contact person for scientific queries

Name

Dr Stephen Asha

Address

Emergency Department, St George Hospital
Gray St, Kogarah, NSW, 2217

Country

Australia

Phone

+61 2 9113 1650

Fax

+61 2 9113 3946

[email protected]

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	Benztropine for the relief of acute non-traumatic neck pain (wry neck): A randomised trial.	2015	https://dx.doi.org/10.1136/emermed-2014-204317

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

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