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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000566639
Ethics application status
Approved
Date submitted
26/05/2014
Date registered
28/05/2014
Date last updated
29/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the perceived intensity of pain experienced with Delayed Onset Muscle Soreness change noticeably over the course of one hour?
Scientific title
Does the perceived intensity of pain experienced with Delayed Onset Muscle Soreness change noticeably over the course of one hour? A longitudinal cohort pilot study involving normal subjects.
Secondary ID [1] 284652 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Experimental deep tissue pain 291969 0
Condition category
Condition code
Musculoskeletal 292318 292318 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Arm 1: Participant contracts the quadriceps muscle and scores their experienced pain according to VAS.
Arm 2: Participant contracts the quadriceps muscle and scores their experienced pain according to VAS.
Arm 3: Participant contracts the quadriceps muscle and scores their experienced pain according to VAS.
Arm 4: Participant contracts the quadriceps muscle and scores their experienced pain according to VAS.
Each contraction will be held for 5 seconds and the contractions will be performed 3 times for each arm.
There will be a 15 minute wash-out period between each arm.
Intervention code [1] 289434 0
Not applicable
Comparator / control treatment
No control in this experiment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292181 0
Pain intensity using Visual Analogue Scale (VAS)
The experimentally-induced deep tissue pain will be induced by inducing DOMS in our subject's quadricep's muscles. This will be done at the first session, 48 hours prior to the testing session. DOMS will be achieved by taking the subjects through a specific protocol involving several repetitions of eccentric contractions of the quadricpes muscle.
Timepoint [1] 292181 0
Testing will involve the participants contracting their affected quadriceps muscle, and reporting their experienced level of pain. This will be done at 15 minute intervals for the duration of one hour, 48 hours after the eccentric exercise protocol.
Secondary outcome [1] 308381 0
nil
Timepoint [1] 308381 0
nil

Eligibility
Key inclusion criteria
Proficiency in written and spoken English
Able to provide informed written consent
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Leg pain that has required a visit a health care professional in the previous 12 months.
Fractures or dislocations in the leg within the last 5 years.
Any neurological disorder.
Ongoing lumbar spine problems.
Abnormal tenderness to palpation of the soft tissues of the thigh.
Reduced or excessive knee or hip movement.
Regular consumption of anticoagulant medication or medications known to influence pain sensitivity (e.g. painkillers, anti-inflammatories, antidepressants).
Recent quadriceps strength training (previous 6 months).
Any ongoing medical problems.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The stability of the pain measure will be assessed over time using ICC's, and we will also calculate SEM.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289277 0
University
Name [1] 289277 0
UNDA Student Project Costs University of Notre Dame
Address [1] 289277 0
19 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959
Country [1] 289277 0
Australia
Primary sponsor type
University
Name
University of Notre Dame
Address
19 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959
Country
Australia
Secondary sponsor category [1] 287950 0
None
Name [1] 287950 0
Address [1] 287950 0
Country [1] 287950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291046 0
Human Research Ethics Committee, University of Notre Dame
Ethics committee address [1] 291046 0
19 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959
Ethics committee country [1] 291046 0
Australia
Date submitted for ethics approval [1] 291046 0
31/03/2014
Approval date [1] 291046 0
08/05/2014
Ethics approval number [1] 291046 0
014036F

Summary
Brief summary
Prior to our research study, we need to perform a pilot study to ensure the stability of the intensity of the DOMS in our subjects over a period of 1 hour, so that any changes recorded in intensity of DOMS during the main study may not be attributed to the factor of time. These data will be used to calculate the sample size in the main study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48638 0
A/Prof Benedict Wand
Address 48638 0
University of Notre Dame 19 Mouat Street, Fremantle, WA 6959
Country 48638 0
Australia
Phone 48638 0
+61 894330203
Fax 48638 0
Email 48638 0
Benedict.Wand@nd.edu.au
Contact person for public queries
Name 48639 0
Mrs Megan van Selm
Address 48639 0
University of Notre Dame 19 Mouat Street, Fremantle, WA 6959
Country 48639 0
Australia
Phone 48639 0
+61894330009
Fax 48639 0
Email 48639 0
megan.vanselm@nd.edu.au
Contact person for scientific queries
Name 48640 0
Mrs Megan van Selm
Address 48640 0
University of Notre Dame 19 Mouat Street, Fremantle, WA 6959
Country 48640 0
Australia
Phone 48640 0
+61894330009
Fax 48640 0
Email 48640 0
megan.vanselm@nd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary