ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001141437

Ethics application status

Approved

Date submitted

12/08/2016

Date registered

22/08/2016

Date last updated

12/06/2019

Date data sharing statement initially provided

12/06/2019

Date results information initially provided

12/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The influence of pain education on pain responses to exercise in people with chronic pain and healthy individuals

Scientific title

The influence of pain education on pain responses to exercise in people with chronic pain and healthy individuals

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Fibromyalgia

Knee osteoarthritis

Hip osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will involve general education about pain during exercise followed by explicit education about pain relieving effects of exercise. The education will be delivered face to face by an Accredited Exercise Physiologist on an individual basis but will not be personalised for each participant. The intervention education component of the experiment will last approximately 15 minutes and the entire experimental session will last approximately 60 - 90 minutes with the rest of the experimental session to consist of participants completing questionnaires relating to their health and level of physical activity (30 min), a bout of aerobic exercise (20 min), and assessments of pressure pain threshold before and after exercise (10 min). All testing will be performed at Neuroscience Research Australia. For participants in the chronic pain group, abstinence from analgesic medication(s) must begin 23 hours prior to the start of their experimental session.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The comparator treatment will involve the same general pain education that is delivered to the intervention group but, in place of explicit education about pain relieving effects of exercise, greater emphasis will be placed on the nature of pain during exercise and the distinction between pain intensity and pain unpleasantness. The comparator treatment will be delivered face to face by an Accredited Exercise Physiologist on an individual basis but will not be personalised to each participant. The comparator education component of the experiment will last approximately 15 minutes and the entire experimental session will last approximately 60 - 90 minutes with the rest of the experimental session to consist of participants completing questionnaires relating to their health and level of physical activity (30 min), a bout of aerobic exercise (20 min), and assessment of pressure pain threshold before and after exercise (10 min). All testing will be performed at Neuroscience Research Australia. For participants in the chronic pain group, abstinence from analgesic medication(s) must begin 23 hours prior to the start of their experimental session.

Control group

Active

Outcomes

Primary outcome [1]

Change in pressure pain threshold assessed using a handheld algometer.

Timepoint [1]

Immediately prior to exercise and immediately following exercise

Secondary outcome [1]

Change in self-reported pain assessed using a 0-10 numerical and categorical pain scale

Timepoint [1]

Immediately before exercise, every 5 minutes during exercise (e.g. at 5, 10, 15 and 20 minutes of the exercise protocol), and then 5 minutes following exercise cessation.

Secondary outcome [2]

Assessment of knowledge and beliefs about exercise and pain arising from the education intervention assessed using a questionnaire designed specifically for this study. The questionnaire consists of 5 questions that are each scored on a 7-point Likert scale anchored at one end with "Strongly agree" and at the other end with "Strongly disgaree".

Timepoint [2]

The questionnaire is administered immediately after the education intervention prior to the assessment of pressure pain thresholds and the exercise bout.

Eligibility

Key inclusion criteria

Participants in the chronic pain group must be able to speak, read and write English and have a specialist diagnosis of knee or hip osteoarthritis or fibromyalgia. Participants in the chronic pain group must also be able to refrain from analgesic medications for 24 hours.

Participants in the healthy group must be able to speak, read and write English.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

For both groups: presence of a severe psychiatric, cardiovascular, pulmonary, metabolic and/or neurological disease or any other reason that it is not medically suitable for them to perform aerobic exercise.

For the chronic pain group: any other type of arthritis apart from osteoarthritis of the knee or hip or another cause of chronic pain other than osteoarthritis or fibromyalgia.

For the healthy group: currently experiencing pain, experienced musculoskeletal pain in the past 3 months, or have a history of chronic pain.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

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

Screening to determine eligibility for the study will be performed without knowledge of the allocation for an enrolled participant. Allocation concealment will be done using sealed opaque envelopes.

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

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size planning:
Sample size calculations were made on the basis of detecting a difference in the magnitude of the change in pain by exercise (measured by the change in pressure pain threshold) between the intervention and comparator education arms within each group (chronic pain and healthy). In people with chronic pain, exercise has a small-moderate effect on pain and we estimate a change in pressure pain threshold of approximately 0.4 kg/cm2 to represent a clinically meaningful difference (Naugle et al, 2012). Assuming a difference in the change in pressure pain threshold of 0.4 +/- 0.4 kg/cm2 between the intervention and comparator arms (Naugle et al, 2012; Burrows et al, 2014; Newcomb et al 2011), 17 participants are needed per arm (i.e. 34 people with chronic pain) with a power of 80%, alpha of 0.05 and an independent samples t-test. For the healthy group, exercise has a larger effect on pain than for people with chronic pain (Naugle et al, 2012), but this could potentially limit the scope for pain responses to exercise to be changed by the intervention. There is also no context to determine a 'clinically meaningful' difference in pain threshold for this population. Consequently, we have assumed a smaller difference in pressure pain threshold of 0.25 +/- 0.25 kg/cm2 to represent a meaningful change. 20 participants are needed per arm (i.e. 40 healthy participants) to detect a difference of this magnitude between the intervention and comparator arms, with a power of 80% and alpha of 0.05. Therefore, a total of 74 participants are needed for this experiment (34 with chronic pain and 40 healthy individuals).

Analysis of outcomes:
The primary outcome, which is the change in pressure pain threshold from before to after exercise compared between the intervention and comparator arms within each group (healthy and chronic pain), will be analysed using effect sizes and independent t-tests on the change scores. Differences in pressure pain threshold between the intervention and comparator arms at baseline will be determined using independent t-tests. Subsidiary analyses of the effect of exercise on pressure pain thresholds within each study arm will be done using paired t-tests. No inferential statistical tests are planned to compare the healthy and chronic pain groups for the primary or secondary outcome measures.

The secondary outcomes are the 0-10 change in pain during exercise and the assessment of knowledge and beliefs about exercise and pain. Differences between the intervention and comparator arms for the 0-10 change in pain during exercise will be analysed using independent t-tests. Descriptive statistics will be generated from the Likert scale responses to the questions regarding exercise and pain; differences between the intervention and comparator arms for these responses will be analysed using Mann-Whitney U tests. Chronic exercise has hypoalgesic effects in both fibromyalgia and knee osteoarthritis (Fransen et al, 2015; Busch et al, 2007), but the effect of acute exercise on pain in these two conditions is more variable. Subgroup analyses will be performed on differences in the effects of the education intervention, and of exercise, on the primary and secondary outcome measures between people with fibromyalgia and knee osteoarthritis. This will be done using independent sample t-tests.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/08/2016

Actual

30/08/2016

Date of last participant enrolment

Anticipated

Actual

1/11/2016

Date of last data collection

Anticipated

1/11/2019

Actual

1/11/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke St
Canberra ACT 2061

Country [1]

Australia

Primary sponsor type

University

Name

The University of New South Wales

Address

The University of New South Wales
Sydney, NSW, 2052. Australia

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

Neuroscience Research Australia

Address [1]

Margarete Ainsworth Building
Neuroscience Research Australia
Barker St, Randwick, NSW 2031

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW Human Research Ethics Committee

Ethics committee address [1]

UNSW Research Ethics Compliance & Support
The University of New South Wales
Sydney, NSW, 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/08/2015

Approval date [1]

15/12/2015

Ethics approval number [1]

HC15438

Summary

Brief summary

Pain is multifactorial and involves both biological and psychological components. Multi-disciplinary treatment approaches incorporating drugs, cognitive-behavioural therapy and exercise interventions are the most efficacious for managing chronic pain. Single sessions of exercise and pain education are both demonstrated to have positive effects on pain in people with chronic pain such as fibromyalgia and osteoarthritis, however it is not known whether pain education delivered immediately prior to exercise can enhance the efficacy of exercise in relieving pain. Recent studies from our group have identified that the pain relieving effects of exercise involve a psychological component that influences the appraisal of pain; this would likely be augmented by a combination of exercise and education. The current project will examine the effect of explicit pain education about the pain relieving effect of exercise, compared to more general exercise and pain education, on pain responses to exercise in people with chronic pain (fibromyalgia and osteoarthritis) and healthy individuals. The results will provide insight into: 1) the impact of pain education on the pain response to exercise; and 2) whether this differs between healthy individuals and people with chronic pain. The outcomes may have implications for how exercise and pain education are combined in clinical practice in the management of chronic pain.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Janet Taylor

Address

Margarete Ainsworth Building
Neuroscience Research Australia
Barker St, Randwick, NSW, 2031

Country

Australia

Phone

+61 2 9399 1716

Fax

[email protected]

Contact person for public queries

Name

Mr Matthew Jones

Address

School of Medical Sciences
The University of New South Wales
Sydney, NSW, 2052

Country

Australia

Phone

+61 2 9385 9032

Fax

[email protected]

Contact person for scientific queries

Name

Mr Matthew Jones

Address

School of Medical Sciences
The University of New South Wales
Sydney, NSW 2052

Country

Australia

Phone

+61 2 9385 9032

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Study results article	Yes	Jones, MD., Valenzuela, T., Booth, J., Taylor, JL.... [More Details]
Basic results	No		371275-(Uploaded-11-06-2019-14-24-26)-Basic results summary.docx
Plain language summary	No	The mechanisms through which acute exercise reduce... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Explicit Education About Exercise-Induced Hypoalgesia Influences Pain Responses to Acute Exercise in Healthy Adults: A Randomized Controlled Trial.	2017	https://dx.doi.org/10.1016/j.jpain.2017.07.006

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

Trial Review

Documents added manually

Documents added automatically