Trial Review

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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] 287899 0
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 1475 0
Condition category
Condition code
Musculoskeletal 1571 1571 0 0

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] 1477 0
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] 2167 0
Quantitative sensory testing battery including: Mechanical pressure pain sensitivity in muscles
Timepoint [1] 2167 0
Pre and post exercise at Day 0 and pre, during and post hypertonic saline induced muscle pain at Day 1and 2.
Primary outcome [2] 2168 0
Quantitative sensory testing battery including: Pain intensity profile (VAS, onset, duration), and referred pain areas.
Timepoint [2] 2168 0
During hypertonic saline induced muscle pain at Day 1and 3.
Primary outcome [3] 2169 0
Quantitative sensory testing battery including: McGill Pain Questionnaire
Timepoint [3] 2169 0
Post hypertonic saline induced muscle pain at Day 1 and 4.
Primary outcome [4] 2170 0
Quantitative sensory testing battery including: Maximal grip strength and maximal wrist extension force.
Timepoint [4] 2170 0
Pre and post exercise at Day 0 and at Day 1 pre, during and post hypertonic saline induced muscle pain
Secondary outcome [1] 3782 0
Muscle soreness (modified Likert scale).
Timepoint [1] 3782 0
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?
No
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
40
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 1713 0
University
Name [1] 1713 0
Curtin University
Country [1] 1713 0
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] 1512 0
Individual
Name [1] 1512 0
Professor Tony Wright
Address [1] 1512 0
School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth, WA 6845
Country [1] 1512 0
Australia
Secondary sponsor category [2] 1513 0
Individual
Name [2] 1513 0
Professor Stephan Schug
Address [2] 1513 0
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] 1513 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3171 0
School of Physiotherapy, Curtin University of Technology
Ethics committee address [1] 3171 0
Ethics committee country [1] 3171 0
Australia
Date submitted for ethics approval [1] 3171 0
Approval date [1] 3171 0
12/10/2006
Ethics approval number [1] 3171 0
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 27411 0
A/Prof Helen Slater
Address 27411 0
School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth WA 6845
Country 27411 0
Australia
Phone 27411 0
+61 8 9266 3099
Fax 27411 0
Email 27411 0
[email protected]
Contact person for public queries
Name 10666 0
A/prof Helen Slater
Address 10666 0
School of Physiotherapy and Exercise Science, Curtin University
Country 10666 0
Australia
Phone 10666 0
+61 8 92663099
Fax 10666 0
+61 8 92663699
Email 10666 0
[email protected]
Contact person for scientific queries
Name 1594 0
A/Prof Helen Slater
Address 1594 0
School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth WA 6845
Country 1594 0
Australia
Phone 1594 0
+61 8 92663099
Fax 1594 0
+61 8 92663699
Email 1594 0
[email protected]

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