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Trial registered on ANZCTR

Registration number

ACTRN12614000563662

Ethics application status

Approved

Date submitted

20/05/2014

Date registered

27/05/2014

Date last updated

3/11/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Does temporarily altering visual perception of limb size have a modulatory effect on deep pain perception?

Scientific title

Does temporarily altering visual perception of limb size have a modulatory effect on deep pain perception? A repeated-measures randomised trial of normal subjects.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1156-9036

Trial acronym

Linked study record

Health condition

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

Experimental Deep tissue pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: Participant observes the quadriceps muscle during quadriceps muscle contraction
Arm 2: Participant observes the quadriceps muscle through magnifying lenses during quadriceps muscle contraction
Arm 3: Participant observes the contralateral thigh during quadriceps muscle contraction
Arm 4: Participant observes a neutral object during quadriceps muscle contraction

Each contraction will be held for 5 seconds and the contractions will be performed 3 times for each visual condition.

There will be a 5 minute wash-out period between each condition

Intervention code [1]

Treatment: Other

Comparator / control treatment

Observation of a neutral object during a quadricpes muscle contraction.

Control group

Active

Outcomes

Primary outcome [1]

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]

Immediately post-intervention

Secondary outcome [1]

Subjects estimated the effect of the glasses using a nine-point scale from -4 (extremely shrunken) to 4 (extremely enlarged) where 0 reflects no perceived change in the mid-thigh width.

Timepoint [1]

This amendment was made prior to commencing data collection. The subjects were asked to rate the degree of magnification they perceived prior to removing the glasses, and immediately after testing, in the magnified condition only. The other 3 conditions did not involve attempts to magnify the preceived view of the mid-thigh and thus this scale was not assessed following testing.

Eligibility

Key inclusion criteria

Proficiency in written and spoken English
Able to provide informed written consent

Minimum age

18 Years

Maximum age

50 Years

Sex

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 of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

Potential subjects that fulfil the inclusion criteria will be given the Plain Language Statement and will need to sign the consent form. Every subject will undergo the same process to induce DOMS in their non-dominant quadriceps muscle. They will then be required to return 48 hours later and will need to score >3 on a validated modified Likert scale to be included in the study. The scale reflects the current level of pain experienced in the quadriceps muscle.If included in the study, each subject will undergo the muscle testing procedures under all 4 visual conditions. A five minute washout period will be used between each condition At the time of determining whether the subject has sufficient DOMS to continue the study, the researcher will not know the order of visual conditions that the next subject will be exposed to, should s/he be accepted. Allocation concealment will be ensured by randomising the sequence of visual conditions. This randomisation will be computer generated by an independent person and will be counter balanced.

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

The randomisation sequence will be computer generated by an independent person; randomisation will be concealed and counter balanced.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Randomised, crossover, repeated-measures controlled experiment.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Carry-over and cross-over effects will be explored. Primary analysis will compare pain intensity scores across the 4 conditions.

The number of participants has been extimated to be approximately 30, however the final numbers for the study will be calculated after performance of the pilot study. From the pilot study we will be able to determine the standard error of measurement (using the ICC as the reliability measure), which will be used as the minimal detectable difference, as well as data on the within subject correlation of scores. These data will inform a power calculation to arrive at the final sample size. A statistician will be consulted in calculating the final sample size.

Prior to this research study, a pilot study, involving 10 subjects, will be undertaken to ensure the stability of the intensity of DOMS over a period of 1 hour, so that any changes recorded in intensity of DOMS during the research study may not be attributed to the factor of time. Forty-eight hours after the induction of DOMS, using the same protocol as the research study, subjects will repeat the 4 identical muscle contraction tests separated by a 15 minute washout period. The conditions will replicate the process described except that the same visualisation condition will be used across all 4 conditions. Data from this pilot will also inform the power calculation for the final study.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2015

Actual

3/08/2015

Date of last participant enrolment

Anticipated

Actual

26/11/2015

Date of last data collection

Anticipated

Actual

27/11/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

UNDA Student Project Costs
University of Notre Dame

Address [1]

19 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, University of Notre Dame

Ethics committee address [1]

19 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/03/2014

Approval date [1]

08/05/2014

Ethics approval number [1]

014036F

Summary

Brief summary

Recent work has demonstrated that non-informative visualisation of the body part (visualisation of the body part without visualisation of the stimulus) decreases our perception of pain when the stimulus is delivered to the skin. Subsequent investigations by the same group verified this finding, as well as demonstrating that the effect is greater when the body part is magnified and less when the area is minified, suggesting a relationship between body image and pain perception. This is important because there is mounting evidence of disrupted body image in people with persistent pain problems, and the degree of disruption seems to be related to the severity of the clinical condition. These results suggest that normalisation of the size of perception of the painful body part might have potential as a treatment strategy.

The mechanisms underlying the perception of superficial pain produced by noxious stimulation of the skin are thought to be distinct from those mechanisms that underlie perception of pain mediated by noxious stimulation of deep tissues. Importantly, most clinical pain states are associated with noxious input from deep tissue rather than the skin. Moreover, the one study that has investigated visual distortion in a clinical population noted an effect opposite to those noted above. When patients with complex regional pain syndrome performed a task with their painful upper limb, pain was less when their arm was viewed through minifying goggles and more when magnified. 

While there are likely to be numerous differences in the mechanisms underpinning clinical and experimental pain, it is possible and theoretically plausible that the contrasting results were a result of the difference between superficial and the more clinically-relevant deep pain. We wish to explore this possibility by investigating the effect non-informative visualisation of the body area has on experimental deep tissue pain. 
Our primary hypothesis is that visualisation of the body area will have an analgesic effect on experimentally-induced deep tissue pain.  We further hypothesise that visually altering the perceived size of the body part will alter the perception of pain when compared with the baseline condition of no alteration in perceived body part size.

This research is important as it may provide insight into the role body image plays in influencing deep tissue pain as well as suggesting possible management strategies for pain problems.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Benedict Wand

Address

University of Notre Dame
19 Mouat Street, Fremantle, WA 6959

Country

Australia

Phone

+61 894330203

Fax

[email protected]

Contact person for public queries

Name

Megan van Selm

Address

University of Notre Dame
19 Mouat Street, Fremantle, WA 6959

Country

Australia

Phone

+61894330009

Fax

[email protected]

Contact person for scientific queries

Name

Megan van Selm

Address

University of Notre Dame
19 Mouat Street, Fremantle, WA 6959

Country

Australia

Phone

+61 894330009

Fax

[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	Visually induced analgesia in a deep tissue experimental pain model: A randomised crossover experiment.	2018	https://dx.doi.org/10.1002/ejp.1234

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

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