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Trial registered on ANZCTR

Registration number

ACTRN12606000498594

Ethics application status

Approved

Date submitted

29/11/2006

Date registered

4/12/2006

Date last updated

16/11/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of a specific medication or placebo on modulating induced muscle pain

Scientific title

The pharmacologic modulation of experimentally simulated tennis elbow (lateral epicondylalgia) in healthy controls by administration of a ketamine (generic and specific name) or placebo lozenge: improving our understanding of musculoskeletal pain mechanisms

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Experimentally simulated tennis elbow (lateral epicondylalgia) in healthy controls

Condition category

Condition code

Musculoskeletal

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Ketamine (25mg sublingual) will be administered prior to an intense bout of eccentric exercise used to induce delayed onset muscle soreness (DOMS) in the wrist extensors of healthy control subjects. Verum and placebo lozenges will look identical to maintain double blinding. Twenty four hours post-exercise, subjects will receive an infusion of hypertonic saline (1.0mls @ 5%) into the extensor carpi radialis brevis muscle.
Methodology: 1. Induced delayed onset muscle soreness:
The exercise protocol will be performed using the isokinetic mode of the Kin-Com dynamometer (Chattecx Corp. Hixson, TN) as previously described (Slater et al. 2005). The total exercise period will be 25 minutes, with 5 bouts each of 5 minutes duration (60 repetitions per bout), with each bout separated by a minute rest interval; 2. Intramuscular infusion of hypertonic saline: Hypertonic saline will be infused using a computer-controlled pump (IVAC, model 770, USA), with a 10 ml plastic syringe (Graven-Nielsen et al. 1997). A tube (IVAC G30303, extension set with polyethylene inner line) will be connected from the syringe to the disposable needle (27G, 20mm). A bolus injection of 1.0 ml of sterile hypertonic (5.8%) saline will be injected over 40 seconds.
The duration of the total experimental time will therefore be approximately 26 hours with the drug intervention (if active) peaking at 45 minutes after administration. Subjects will partake in one experimental session only and receive either ketamine or placebo, NOT both.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo will be administered prior to an intense bout of eccentric exercise used to induce delayed onset muscle soreness (DOMS) in the wrist extensors of healthy control subjects. Verum and placebo lozenges will look identical to maintain double blinding. Twenty four hours post-exercise, subjects will receive an infusion of hypertonic saline (1.0mls @ 5%) into the extensor carpi radialis brevis muscle. In healthy control subjects, DOMS will be induced with repeated eccentric wrist extension contractions in the non-dominant arm.

Control group

Placebo

Outcomes

Primary outcome [1]

Quantitative sensory testing battery including: Mechanical pressure pain sensitivity in muscles

Timepoint [1]

Pre and post exercise at Day 0 and pre, during and post hypertonic saline induced muscle pain at Day 1and 2.

Primary outcome [2]

Quantitative sensory testing battery including: Pain intensity profile (VAS, onset, duration), and referred pain areas.

Timepoint [2]

During hypertonic saline induced muscle pain at Day 1and 3.

Primary outcome [3]

Quantitative sensory testing battery including: McGill Pain Questionnaire

Timepoint [3]

Post hypertonic saline induced muscle pain at Day 1 and 4.

Primary outcome [4]

Quantitative sensory testing battery including: Maximal grip strength and maximal wrist extension force.

Timepoint [4]

Pre and post exercise at Day 0 and at Day 1 pre, during and post hypertonic saline induced muscle pain

Secondary outcome [1]

Muscle soreness (modified Likert scale).

Timepoint [1]

Pre and post exercise at Day 0 and at Day 1 pre, during and post hypertonic saline induced muscle pain.

Eligibility

Key inclusion criteria

Healthy controls; comprehensive musculoskeletal physical examination will be performed on both upper limbs to ensure full pain free range of elbow and wrist motion, and no abnormal tenderness to palpation of the soft tissues in the extensor muscles of the forearm and wrist (Haker 1993), or abnormally reduced muscle length.

Minimum age

18 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Involvement of the contralateral arm, cervicothoracic spinal pathology, other upper limb musculoskeletal disorders or neurological disorders.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation involves contacting the holder of the allocation schedule who is at central administration

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

Simple randomisation by using a randomization table

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Subjects and assessor (CI) will be blinded. Drug randomisation will be performed independently by Curtin Pharmacy ensuring blinding of allocation. Initial data analysis of will be performed by a research assistant blinded to subject allocation.

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/12/2006

Actual

3/12/2006

Date of last participant enrolment

Anticipated

Actual

20/12/2007

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

GPO Box U1987, Perth WA 6845

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Helen Slater

Address

School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth WA 6845

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Tony Wright

Address [1]

School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth, WA 6845

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Professor Stephan Schug

Address [2]

Chair of Anaesthesiology,
Pharmacology, Pharmacy and Anaesthesiology Unit,
School of Medicine and Pharmacology, University of Western Australia
Director of Pain Medicine, Royal Perth Hospital
Faculty of Medicine, Dentistry & Health Sciences | The University of Western Australia¦
UWA Anaesthesiology¦Level 2, MRF Building, Royal Perth Hospital, GPO Box X2213, Perth, 6847

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

School of Physiotherapy, Curtin University of Technology

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/10/2006

Ethics approval number [1]

107/2006

Summary

Brief summary

The primary aim of this study is to quantitatively measure, in healthy controls, the effects of a pharmacologic agent in attenuating experimentally induced responses simulating the clinical characteristics of lateral epicondylalgia (“tennis elbow”). The primary hypothesis to be tested in this study is: in comparison with a placebo intervention, a pharmacological intervention targeting processes of central sensitisation via blockade of the N-methyl-D-asparate (NMDA) receptor will attenuate the somatosensory and motor effects of experimentally induced pain in healthy control subjects with simulated characteristics of clinical lateral epicondylalgia

Lay version: In the experiment we will investigate what happens to forearm muscle function and pressure pain sensitivity when given a lozenge containing either an active medication or placebo prior to experimentally induced pain in those muscles. These muscles are involved in “tennis elbow” problems in occupational and sporting settings. 

What does it involve? This experiment will be conducted over two days taking about 1.5 hour per session. At the first session you will be given a lozenge (either placebo or an active drug) 1 hour prior to undertaking an intense bout of eccentric exercise in your non-dominant arm. One day later, a muscle in your exercised arm will be injected with hypertonic saline. This injection may generate a short period of muscle pain. Before and after each session a number of measures will be taken:
1. Pressure pain sensitivity at sites around forearm muscles and tendons using a device to measure mechanical pressure sensitivity (pressure algometer); 2. muscle strength of specific elbow muscles. These measures will also be repeated at Day 1 during the hypertonic saline-induced pain.

Trial website

Trial related presentations / publications

Slater H, Graven-Nielsen T, Wright A, Schug SA, Low-Dose Sublingual Ketamine Does Not Modulate Experimentally Induced Mechanical Hyperalgesia in Healthy Subjects, Pain Medicine 2012; 13: 1235–1246

Public notes

Contacts

Principal investigator

Name

A/Prof Helen Slater

Address

School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth WA 6845

Country

Australia

Phone

+61 8 9266 3099

Fax

h.slater@curtin.edu.au

Contact person for public queries

Name

A/prof Helen Slater

Address

School of Physiotherapy and Exercise Science, Curtin University

Country

Australia

Phone

+61 8 92663099

Fax

+61 8 92663699

h.slater@curtin.edu.au

Contact person for scientific queries

Name

A/Prof Helen Slater

Address

School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth WA 6845

Country

Australia

Phone

+61 8 92663099

Fax

+61 8 92663699

h.slater@curtin.edu.au

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

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