Trial Review

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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 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] 289901 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 299862 0
Knee osteoarthritis 299863 0
Hip osteoarthritis 299990 0
Condition category
Condition code
Musculoskeletal 299768 299768 0 0
Osteoarthritis
Other 299769 299769 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Neurological 299883 299883 0 0
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] 295582 0
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] 299233 0
Change in pressure pain threshold assessed using a handheld algometer.
Timepoint [1] 299233 0
Immediately prior to exercise and immediately following exercise
Secondary outcome [1] 326570 0
Change in self-reported pain assessed using a 0-10 numerical and categorical pain scale
Timepoint [1] 326570 0
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] 326666 0
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] 326666 0
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
74
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294266 0
Government body
Name [1] 294266 0
National Health and Medical Research Council
Country [1] 294266 0
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] 293123 0
Other Collaborative groups
Name [1] 293123 0
Neuroscience Research Australia
Address [1] 293123 0
Margarete Ainsworth Building
Neuroscience Research Australia
Barker St, Randwick, NSW 2031
Country [1] 293123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295695 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 295695 0
Ethics committee country [1] 295695 0
Australia
Date submitted for ethics approval [1] 295695 0
03/08/2015
Approval date [1] 295695 0
15/12/2015
Ethics approval number [1] 295695 0
HC15438

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68158 0
A/Prof Janet Taylor
Address 68158 0
Margarete Ainsworth Building
Neuroscience Research Australia
Barker St, Randwick, NSW, 2031
Country 68158 0
Australia
Phone 68158 0
+61 2 9399 1716
Fax 68158 0
Email 68158 0
[email protected]
Contact person for public queries
Name 68159 0
Matthew Jones
Address 68159 0
School of Medical Sciences
The University of New South Wales
Sydney, NSW, 2052
Country 68159 0
Australia
Phone 68159 0
+61 2 9385 9032
Fax 68159 0
Email 68159 0
[email protected]
Contact person for scientific queries
Name 68160 0
Matthew Jones
Address 68160 0
School of Medical Sciences
The University of New South Wales
Sydney, NSW 2052
Country 68160 0
Australia
Phone 68160 0
+61 2 9385 9032
Fax 68160 0
Email 68160 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExplicit Education About Exercise-Induced Hypoalgesia Influences Pain Responses to Acute Exercise in Healthy Adults: A Randomized Controlled Trial.2017https://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.