Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000043235
Ethics application status
Approved
Date submitted
14/12/2017
Date registered
15/01/2018
Date last updated
23/01/2020
Date data sharing statement initially provided
23/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of self-efficacy of patients with chronic pain attending a community based exercise program.
Scientific title
An evaluation of self-efficacy of patients with chronic pain attending a community based exercise program.
Secondary ID [1] 293608 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 305871 0
Condition category
Condition code
Musculoskeletal 305069 305069 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 305074 305074 0 0
Physiotherapy
Neurological 305228 305228 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project is a prospective observational study of participants in a pre existing group exercise program (called Physiocise ) for people with chronic pain. It aims to evaluate the self-efficacy of participants in regards to their pain during a 10 week combined cognitive behavioural therapy and exercise program and whether any changes seen, continue to a three month follow up. This study also aims to understand which components of the Physiocise program, if any, are associated with changes in self efficacy.

Standard Physiocise Protocol: Participants attend a one hour exercise class once a week for ten weeks. The classes will be held at the Physiocise studios in Willoughby Sydney and will have the same physiotherapist teaching each week as well as the same participants. Participants are encouraged to read specific educational material or watch a Physiocise exercise clip that is emailed to them on the Monday of each week. The educational component of classes is taught by the Physiotherapist and includes teaching participants about chronic pain, CBT strategies, strategies for relieving their pain, postural advice and movement advice. The exercise component of the classes involves postural re-education as well as teaching better movement patterns whilst also practising strengthening exercises. Classes are planned to focus on functional tasks such as standing, sitting, bending, walking, lifting and stairs. The information is presented by the class physiotherapist then practised in the classroom as a group.
The sessions in weeks 1, 2, 3 and 4 consist of approximately 40 minutes of education and 20 minutes of movement re-education and exercise. The sessions in weeks 5 - 10 consist of approximately 15 minutes of education and 45 minutes of movement re-education and exercise.

As this study is evaluating possible changes to self-efficacy of patients attending a preexisting exercise program the majority of the data being used is collected by Physiocise as a normal part of their program. The only additional questionnaires are a pain self-efficacy questionnaire and a goal attainment scale (GAS). A confidence visual analogue score has been added to the existing homework sheets provided in weeks 1, 5 and 10 of the program.
Intervention code [1] 300035 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304241 0
changes in self efficacy as measured by VAS confidence scores
Timepoint [1] 304241 0
Immediately post-program at Week 10 (primary endpoint) and at 3 month follow up
Primary outcome [2] 304242 0
changes in pain self-efficacy as measured with PSEQ (Pain Self Efficacy Questionnaire) . PSEQ is a validated study developed by Michael Nicholas
Timepoint [2] 304242 0
Immediately post-program at Week 10 (primary endpoint) and at 3 month follow up
Primary outcome [3] 304243 0
changes in goal attainment score as measured with GAS
Timepoint [3] 304243 0
Immediately post-program at Week 10 (primary endpoint) and at 3 month follow up
Secondary outcome [1] 341341 0
changes to pain bothersomeness as measured with the 'bothersome score' which is a scale that has been validated for use.
Timepoint [1] 341341 0
Immediately post-program at Week 10 and at 3 month follow up
Secondary outcome [2] 341342 0
changes to patient function as measured with the PSFS (patient specific functional score) which is validated scale.
Timepoint [2] 341342 0
Immediately post-program at Week 10 and at 3 month follow up
Secondary outcome [3] 341343 0
changes to fear avoidance behaviours as measured with tampa questionnaire
Timepoint [3] 341343 0
Immediately post-program at Week 10 and at 3 month follow up
Secondary outcome [4] 341344 0
changes to disability as measured with roland morris disability questionnaire
Timepoint [4] 341344 0
Immediately post-program at Week 10 and at 3 month follow up
Secondary outcome [5] 341345 0
changes to pain as measured with a pain visual analogue score
Timepoint [5] 341345 0
Immediately post-program at Week 10 and at 3 month follow up

Eligibility
Key inclusion criteria
1 Chronic pain which may or may not be back pain (is pain lasting > 3 months duration)
2 VAS greater than or equal to 2
3 Be able to read and understand written and spoken English
4 Have completed their Initial Assessments at Physiocise in the four weeks prior to the commencement of the exercise class.
5 Be 18 years or older
6 Have access to the internet for the 3 month email follow up
7 Be able to participate the full ten weeks of the Physiocise Foundations program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Currently pregnant
2 Low back pain that is attributable to a recognisable known specific pathology (eg infection, tumour, fracture, inflammatory disorder).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We expect to recruit into the research, 60 participants who are completing the ten week program at Physiocise. Recruitment could continue up to 100 participants should more people enroll in the program who meet the inclusion criteria. Standard participation in the Physiocise Foundations program is 100 people per term and 60-100 participants is a good representation of this population. As this study is an evaluation of an existing program and not an experimental design the recruitment number of 60 -100 was based on the number of people who enroll in the program per term rather than for a power analysis. The researchers feel that the recruitment of a possible 50%-60% of the standard enrollments is a strong representation of the population.

All statistical analyses will be conducted using IBM Statistical Package for Social Sciences (SPSS) version 24 for Macintosh and Microsoft Excel for Mac 2011 (version 14.7.0). Descriptive statistics will be used to characterise participants demographic data and present primary and secondary outcomes measure. This will be presented as mean with standard deviation or median and interquartile range as appropriate for all continuous data, with presentation of frequencies, percentages and proportions for categorical variables.
Correlational analyses will be conducted using Pearson’s Coefficient for continuous data and Spearman’s Rank Coefficient for categorical data, or Pearson Chi-Square for binomial data.
Comparisons between pre-and post-program data will be conducted using Pearson’ Coefficent or Spearman’s rank coefficient where appropriate or McNemar’s Test for binomial data.
Pre-post tests for change: Paired t-tests will be used for continuous data and ANOVA will be used for multiple time points.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial was completed within the time available for a Master Of Research
Date of first participant enrolment
Anticipated
19/01/2018
Actual
19/01/2018
Date of last participant enrolment
Anticipated
27/04/2018
Actual
24/07/2018
Date of last data collection
Anticipated
13/10/2018
Actual
11/12/2018
Sample size
Target
60
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 18317 0
2068 - Willoughby

Funding & Sponsors
Funding source category [1] 298223 0
University
Name [1] 298223 0
Macquarie University
Country [1] 298223 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Department of Health Professions
Faculty of Medicine & Health Sciences
Ground Floor, 75 Talavera Rd
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 297339 0
None
Name [1] 297339 0
Address [1] 297339 0
Country [1] 297339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299231 0
Macquarie University Human Research Ethics Committee (Medical Sciences).
Ethics committee address [1] 299231 0
Ethics committee country [1] 299231 0
Australia
Date submitted for ethics approval [1] 299231 0
11/10/2017
Approval date [1] 299231 0
30/11/2017
Ethics approval number [1] 299231 0
5201700991

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2268 2268 0 0
/AnzctrAttachments/374170-5201700991_Jones - Approval 30-11-2017.pdf (Ethics approval)
Attachments [2] 2269 2269 0 0
/AnzctrAttachments/374170-MQ_PICF Physiocise foundations_v2.doc (Participant information/consent)

Contacts
Principal investigator
Name 79738 0
A/Prof Taryn Jones
Address 79738 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 79738 0
Australia
Phone 79738 0
612 9850 2796
Fax 79738 0
612 9850 6630
Email 79738 0
[email protected]
Contact person for public queries
Name 79739 0
Kate Roberts
Address 79739 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 79739 0
Australia
Phone 79739 0
612 9850 2796
Fax 79739 0
Email 79739 0
[email protected]
Contact person for scientific queries
Name 79740 0
Kate Roberts
Address 79740 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 79740 0
Australia
Phone 79740 0
612 9850 2796
Fax 79740 0
Email 79740 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.