Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000631404
Ethics application status
Approved
Date submitted
5/05/2016
Date registered
16/05/2016
Date last updated
17/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Learned Pacing for adults with Chronic Pain: A Randomised Controlled Trial Feasibility Study
Scientific title
Learned Pacing for adults with Chronic Pain: A Randomised Controlled Trial Feasibility Study
Secondary ID [1] 287774 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 298652 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298716 298716 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A common intervention used to treat Chronic Pain in clinical practice is ‘pacing’. A key pain management strategy, pacing aims to enable individuals with Chronic Pain to reduce pain severity and to improve ability to participate in chosen occupations. Pacing involves preplanning, alternating between participating in an occupation, and taking a break, before pain escalates to a flare up (Sternbach, 1978). Pacing can be used over time to gradually build up tolerances in occupational participation (Nielson, Jensen, Karsdorp, & Vlaeyen, 2013) within existing or reintroduced occupations. Pacing as a learned strategy significantly differs from how individuals naturally pace (Andrews, Strong, & Meredith, 2012). For example, Murphy, Smith, and Alexander (2008) found that the way women with osteoarthritis naturally pace their occupations might be a reaction to exacerbating pain and fatigue severity.

The intervention group will receive a Learned Pacing intervention which will be provided individually and face to face by associate researcher Lauren Guy, over three separate sessions lasting between 60- 90 minutes, which will be provided over three consecutive weeks. All intervention sessions will take place at the Community Based Rehabilitation Center at Sunshine Hospital. All resources provided within the intervention are based on the book ‘Explain Pain’ by Butler and Moseley (2013).

Objectives for intervention session 1:

- To understand the background and rationale for pacing, see pg. 106 & 107 (Butler & Moseley, 2013), for information for which the education will be based on)
- To understand what pacing is, see pg. 116- 119 (Butler & Moseley, 2013), for information for which the education will be based on)
- To understand the proposed benefits of pacing, see pg. 116- 119 (Butler & Moseley, 2013), for information for which the education will be based on)
- To understand how to implement pacing into daily occupations, including the identification of baseline times, see pg. 116- 119 (Butler & Moseley, 2013), for information for which the education will be based on.
- To understand the concept of pacing up occupational tolerances over time, see pg. 116- 119 (Butler & Moseley, 2013), for information for which the education will be based on.
- To receive a homework task which will enable participants to log their pacing implementation into daily occupations and to identify pacing baseline times.
- To provide pages 106 & 107, 116- 119 (Butler & Moseley, 2013) for clients to take home to read
- To identify a meaningful occupation/s to practically implement pacing into in the following session

Objectives for intervention session 2:

- To reflect on the implementation of pacing into daily occupations.
- To discuss identification of pacing baseline times.
- To troubleshoot barriers to the implementation of pacing into daily occupations.
- To practically implement pacing into an occupation (identified in the previous session).
- To receive homework to continue to log implementation of pacing into daily occupations and to begin pacing up to improve occupational tolerances.

Objectives for intervention session 3:

- To reflect on the implementation of pacing into daily occupations.
- To reflect on the pacing up of occupational tolerances.
- To troubleshoot barriers to the implementation of pacing into daily occupations and increasing occupational tolerances.
- To practically implement pacing into the occupation practiced in the previous session, with increased tolerances.
- To be encouraged to continue implementation of pacing into daily occupations and increasing occupational tolerances.

Intervention adherence will be monitored through the use of a pacing log sheet (as mentioned above).

Reference

Butler, D., & Moseley, L. (2013). Explain Pain (Second ed., pp. 106-107, 116- 119). Adelaide City West, Australia Noigroup Publications.
Intervention code [1] 294659 0
Rehabilitation
Comparator / control treatment
The Waitlist Control group will not receive the experimental intervention, however participants allocated to this group will receive usual care subsequently with a current wait list time of approximately 3 months. Usual care is the service the participants were originally referred for, which is a multidisciplinary pain management service. The multidisciplinary pain management service comprises allied health professionals (e.g. psychology, physiotherapy, occupational therapy) who work with clients to facilitate improvement in their ability to self manage their chronic pain.

There is no direct incentive for participants to complete data collection, however participants will be made aware that their participation will support the research base for the Learned Pacing intervention.
Control group
Active

Outcomes
Primary outcome [1] 298194 0
Occupational performance will be assessed through the use of the Canadian Occupational Performance Measure (COPM). The COPM is a standardized outcome measure designed to assist individuals to identify difficulties with occupational performance and satisfaction in relation to their meaningful occupations (McColl & Pollock, 2005). The COPM involves a therapist conducting a semi-structured interview, goal setting and goal scoring with the participant (McColl & Pollock, 2005).
Timepoint [1] 298194 0
Week one (prior to learned pacing intervention) and five (post learned pacing intervention). Please note that the learned pacing intervention will occur at weeks 2, 3 and 4.
Primary outcome [2] 298195 0
Occupational satisfaction will be assessed through the use of the Canadian Occupational Performance Measure (COPM). The COPM is a standardized outcome measure designed to assist individuals to identify difficulties with occupational performance and satisfaction in relation to their meaningful occupations (McColl & Pollock, 2005). The COPM involves a therapist conducting a semi-structured interview, goal setting and goal scoring with the participant (McColl & Pollock, 2005).
Timepoint [2] 298195 0
Week one (prior to learned pacing intervention) and five (post learned pacing intervention). Please note that the learned pacing intervention will occur at weeks 2, 3 and 4.
Secondary outcome [1] 323452 0
Pain severity will be assessed through the use of the Brief Pain Inventory Short From (BPI). The BPI is a self-administered questionnaire outcome measure.
Timepoint [1] 323452 0
Week one (prior to learned pacing intervention) and five (post learned pacing intervention). Please note that the learned pacing intervention will occur at weeks 2, 3 and 4.
Secondary outcome [2] 323453 0
Pain interference will be assessed through the use of the Brief Pain Inventory Short From (BPI). The BPI is a self-administered questionnaire outcome measure.
Timepoint [2] 323453 0
Week one (prior to learned pacing intervention) and five (post learned pacing intervention). Please note that the learned pacing intervention will occur at weeks 2, 3 and 4.

Eligibility
Key inclusion criteria
- Participants with Chronic Pain as diagnosed by a medical practitioner. The study will include participants with Chronic Pain, which has originated from any source. Using a broad inclusion criterion will support the aim that the participants are representative of the population of interest (Pocock, 1983).
- Pain has persisted for greater than or equal to 3 months. Pain, which has persisted for greater than or equal to 3 months, is considered Chronic Pain, as opposed to Acute Pain.
- Aged greater than or equal to 18 years old, secondary to the intervention being targeted to an adult level of health literacy.
- Participants must be able to attend 5 visits to the Community Rehabilitation Center where the study is being conducted.
- Participants are happy to be randomly assigned.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Surgery within the last (less than or equal to) 3 months secondary to post surgical pain being treated as Acute Pain, which differs from the treatment of Chronic Pain.
- Participants, who are unable to read, write or understand English secondary to the outcome measures and intervention being provided in English. The funding of interpreters is not feasible given insufficient funds.
- Past or current treatment with a multidisciplinary Pain Management Service, given the possible affects of the Learned Pacing intervention may be diminished (Pocock, 1983).
- Participants who are unable to collaboratively complete the primary outcome measure with the researcher (e.g. develop goals, score goals). This will only be able to be confirmed once the outcome measure is attempted with the client.
- Participants who are due to commence usual care within the following 5 weeks
- Participants with any cognitive impairment. If a participant’s medical history includes cognitive impairment they will be excluded to ensure participants are able to provide informed consent to participate in the research project.
- Participants who are pregnant.

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)
- At first contact, following data collection and collation of demographic information, the associate researcher Lauren Guy will open the participants corresponding envelope to reveal their group allocation. All participants will be made aware of their group allocation at this time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
- As eligible participants are entered into the trial, they will be consecutively allocated a trial number, 1 to 20.
- Principle researcher Chris Bruce, who is not involved in the data collection or provision of intervention, will use a random number generator to generate simple random allocation according to participant trial numbers, with a 1:1 allocation ratio. To prevent selection bias allocations will be concealed in a separate non-transparent envelope labelled with the participant trial number. Envelopes will then be sealed before being provided to the associate researcher Lauren Guy. The envelope will only be opened following data collection at week 1, to reveal which group the participant is allocated.
- Participants will be randomly assigned to either the Learned Pacing intervention or Waitlist Control group.
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
- Data analysis will be conducted using IBM SPSS Statistics (IBM Corporation Software Group, Somers, NY). Data analysis will be conducted by principle researchers Dr Carol McKinstry, Mr Chris Bruce, and by associate researcher Lauren Guy.

- A feasibility study design is being used because an effect size cannot be estimated from the literature. Therefore this research project will use a power-based approach that will yield an effect size of the treatment. This will enable a priori power analysis that will enable the calculation of an adequate sample size for future trials.

- Nonparametric analysis for dependent variable ordinal data will be used.

- The main analysis used will be summary statistics. Data will be presented as descriptive statistics and findings will be treated as being preliminary (Lancaster et al., 2004). The size of the intervention effect size will be analysed within subjects and between groups, and will be reported as the difference between the means in addition to the 95% confidence interval.

- In addition to the main analysis, inferential analysis will be used with the Wilcoxon signed-ranks test and Mann-Whitney U test.

- Wilcoxon signed-ranks test will be used to determine if there is a difference between paired results in relation to the direction and magnitude of change (Portney & Watkins, 2009). This data analysis approach will enable comparison of pre and post scores within the same participant in relation to the outcomes of interest.

- Mann-Whitney U test will be used to determine the difference between two independent samples (Portney & Watkins, 2009). This data analysis approach will enable comparison between the LP and WC groups, in relation to the outcomes of interest.

- The primary analysis will be intention-to-treat, where participants' data will be analysed according to which group the participant was allocated to.

- The primary end point for the study is a mean improvement, of at least + 2 points, in both occupational performance and satisfaction in the intention to treat population in the Learned Pacing intervention group.

- Data analysis will confirm whether there has been a statistically significant change in outcome scored over two time points: pre intervention and post intervention.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Slow rate of recruitment.
Aims of the feasibility study achieved.
Time restriction secondary to university requirements.
Date of first participant enrolment
Anticipated
19/05/2016
Actual
4/08/2016
Date of last participant enrolment
Anticipated
4/04/2017
Actual
28/03/2017
Date of last data collection
Anticipated
9/05/2017
Actual
9/05/2017
Sample size
Target
20
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5743 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 13212 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 293520 0
Hospital
Name [1] 293520 0
Community Based Rehabilitation, Sunshine Hospital
Country [1] 293520 0
Australia
Funding source category [2] 293546 0
University
Name [2] 293546 0
La Trobe University
Country [2] 293546 0
Australia
Primary sponsor type
Hospital
Name
Community Based Rehabilitation, Sunshine Hospital
Address
Community Based Rehabilitation
Sunshine Hospital
Western Health
176 Furlong Rd
St Albans
Victoria 3021
Country
Australia
Secondary sponsor category [1] 292342 0
University
Name [1] 292342 0
La Trobe University
Address [1] 292342 0
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora,
Victoria 3086
Country [1] 292342 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294960 0
Melbourne Health Human Ethics Committee
Ethics committee address [1] 294960 0
Level 6
East
300 Grattan Street
Royal Melbourne Hospital
Parkville
Victoria 3050
Ethics committee country [1] 294960 0
Australia
Date submitted for ethics approval [1] 294960 0
24/01/2016
Approval date [1] 294960 0
28/04/2016
Ethics approval number [1] 294960 0
HREC/16/MH/13
Ethics committee name [2] 294961 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 294961 0
Plenty Road & Kingsbury Drive,
Melbourne VIC 3086
Ethics committee country [2] 294961 0
Australia
Date submitted for ethics approval [2] 294961 0
Approval date [2] 294961 0
Ethics approval number [2] 294961 0

Summary
Brief summary
Primary aim:

- To determine whether the performance and satisfaction within meaningful occupations for adults with Chronic Pain improves in response to a Leaned Pacing intervention in comparison to Waitlist Control conditions.

Hypotheses:
- The Learned Pacing intervention group will have greater occupational performance and satisfaction in comparison to the Waitlist Control group

Proposal research design:
- Pilot Randomised Controlled Trial Two Group Pretest- Posttest Design.

Methods:
- Potential participants will be identified from a Community Based Rehabilitation Centre Multidisciplinary Pain Service waitlist and potential participants who consent to participating in the research project will be screened for eligibility based on inclusion/ exclusion criteria,
- Eligible participants will be randomly assigned to either the Learned Pacing intervention or Waitlist Control
- The experimental group intervention is a Learned Pacing intervention and will be provided over three separate sessions lasting between 60- 90 minutes, which will be provided over three consecutive weeks by a qualified Occupational Therapist. Participants allocated to this group will receive usual care subsequently with a current wait list time of approximately 3 months.
- The Waitlist Control group will not receive the experimental intervention, however participants allocated to this group will receive usual care subsequently with a current wait list time of approximately 3 months.
- The Canadian Occupational Performance Measure and the Brief Pain Inventory will be used as the outcome measures to record data, pre and post intervention, according to participant's occupational performance and satisfaction, as well as pain severity and interference.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61290 0
Dr Carol Elizabeth McKinstry
Address 61290 0
La Trobe Rural Health School,
Edwards Rd,
Flora Hill VIC 3550
Country 61290 0
Australia
Phone 61290 0
+61 3 5448 9111
Fax 61290 0
+61 3 5444 7977
Email 61290 0
c.mckinstry@latrobe.edu.au
Contact person for public queries
Name 61291 0
Ms Lauren Guy
Address 61291 0
Community Based Rehabilitation
Sunshine Hospital
Western Health
176 Furlong Rd
St Albans
Victoria 3021
Country 61291 0
Australia
Phone 61291 0
+61 3 8345 0570
Fax 61291 0
+ 61 3 83451339
Email 61291 0
lauren.guy@wh.org.au
Contact person for scientific queries
Name 61292 0
Ms Lauren Guy
Address 61292 0
Community Based Rehabilitation
Sunshine Hospital
Western Health
176 Furlong Rd
St Albans
Victoria 3021
Country 61292 0
Australia
Phone 61292 0
+61 3 8345 0570
Fax 61292 0
+ 61 3 83451339
Email 61292 0
lauren.guy@wh.org.au

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