Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000631404 |
Date of registration:
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16/05/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Learned Pacing for adults with Chronic Pain: A Randomised Controlled Trial Feasibility Study
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Scientific title:
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Learned Pacing for adults with Chronic Pain: A Randomised Controlled Trial Feasibility Study |
Date of first enrolment:
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04/08/2016 |
Target sample size:
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20 |
Recruitment status: |
Stopped early |
URL:
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https://anzctr.org.au/ACTRN12616000631404.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Ms Lauren Guy
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Address:
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Community Based Rehabilitation
Sunshine Hospital
Western Health
176 Furlong Rd
St Albans
Victoria 3021
Australia |
Telephone:
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+61 3 8345 0570 |
Email:
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lauren.guy@wh.org.au |
Affiliation:
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Name:
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Ms Lauren Guy
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Address:
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Community Based Rehabilitation
Sunshine Hospital
Western Health
176 Furlong Rd
St Albans
Victoria 3021
Australia |
Telephone:
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+61 3 8345 0570 |
Email:
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lauren.guy@wh.org.au |
Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Physical Medicine / Rehabilitation - Occupational therapy
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chronic pain; chronic pain
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Intervention(s)
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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 pa
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Primary Outcome(s)
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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).[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. ]
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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). [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. ]
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Secondary Outcome(s)
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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. [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. ]
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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. [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. ]
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Source(s) of Monetary Support
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Community Based Rehabilitation, Sunshine Hospital
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La Trobe University
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Ethics review
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Status: Approved
Approval date:
Contact:
Melbourne Health Human Ethics Committee
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Status: Not approved
Approval date:
Contact:
La Trobe University Human Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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