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Trial registered on ANZCTR


Registration number
ACTRN12616000857404
Ethics application status
Approved
Date submitted
27/06/2016
Date registered
30/06/2016
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Culturally informed assessment and treatment of chronic pain
Scientific title
A randomised controlled pilot study investigating the feasibility of, adherence to and satisfaction with a culturally informed physiotherapy assessment and treatment of chronic pain.
Secondary ID [1] 289493 0
Nil
Universal Trial Number (UTN)
U1111-1184-4401
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 299190 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299198 299198 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be evaluated is 'culturally adapted physiotherapy assessment and treatment'. This intervention arm will be delivered by the physiotherapist who developed the culturally adapted pain management physiotherapy protocols from extensive qualitative enquiry, clinical expertise and review of the literature. This treating physiotherapist has a Bachelor of Physiotherapy, a Masters of Manual Therapy and ten years of clinical practice. Participants randomised to this intervention arm will attend a combination of group therapy sessions (approximately two hours’ duration, once a week, for 6 weeks) and up to 4 individualised physiotherapy sessions of 30 minute duration, until treatment conclusion at 3 months. The group sessions will be facilitated by a bilingual health educator and conducted at a local community venue that is accessible by patients from culturally and linguistically diverse backgrounds. The individual physiotherapy sessions will be delivered by the same physiotherapist and with the assistance of an interpreter as required.

The program content is based on current evidence based guidelines for the management of chronic pain that aim to improve patients physical and socio-occupational functioning using CBT principles. In our trial, evidence based pain management content has been adapted to reflect the beliefs, values and behaviours of the three communities of interest. This has included the following components:
- Locating educational material within the unique explanatory model of disease held by each community
- Modifying the educational materials to suit the language and reflect the health literacy of each community
- Using culturally appropriate examples and metaphors for problem solving and activity pacing
- Delivering exercise interventions using culturally specific examples such as traditional dance components
- Locating interventions in familiar and accessible settings
- Emphasising traditional and ethnoculturally relevant coping strategies such as the use of prayer, natural remedies and spiritual relaxation strategies
- Involving family or community members in goal setting and skill implementation
Patients will be given a log book to complete to evaluate compliance with the program content.

The individual sessions will be tailored by the physiotherapist to suit the specific needs of the patient, following a culturally informed assessment protocol. The assessment will explore cultural beliefs and values, degree of alignment with ethnocultural community, spiritual domains and extracting the patient's explanatory model of illness.

Intervention code [1] 295079 0
Rehabilitation
Intervention code [2] 295158 0
Treatment: Other
Comparator / control treatment
The control group in this trial is 'evidence informed usual care'. Patients allocated to this treatment arm will receive treatment delivered by a physiotherapist who has not been trained in the culturally adapted assessment or treatment protocols used in this trial. Importantly, all treating physiotherapists will have over two years of clinical experience and will attend a training session familiarising them with evidence based guidelines for the management of chronic pain, including CBT approaches, prior to commencing the trial. This session will incorporate concepts including explaining mechanisms of pain, goal setting, ergonomics, pacing, flare-up management, active coping strategies and exercise prescription for chronic pain.

The mode of delivery of the treatment (individual or group) is at the discretion of the therapist and what is usual practice for the specific community at each site. All participants will have access to professional health interpreting services to facilitate therapy sessions if required and will be delivered in a hospital outpatient setting. Physiotherapists will be able to use their clinical judgement to determine the specific dose and type of treatment for each patient according to their assessment. A maximum of 10 sessions of physiotherapy, of up to 1 hour duration (as needed), over the 3-month intervention period will be set to ensure comparability. The key distinguishing feature between the two interventions is the addition of cultural adaptation assessment and treatment. Treating physiotherapists will be asked to complete a treatment diary to allow adherence to the ‘evidence based’ care to be established
Control group
Active

Outcomes
Primary outcome [1] 298680 0
Adherence: Adherence to the intervention and its specific components will be calculated in two ways: 1) The proportion of the sessions attended relative to the number of sessions scheduled and 2) The average number of home exercise sessions completed a week. The number of home exercise sessions per week will be calculated by review of participant log-books and patient self-report.
Timepoint [1] 298680 0
Both attendance and adherence will be assessed weekly from the start of treatment to treatment conclusion at 3 months.
.
Primary outcome [2] 298681 0
Patient satisfaction with treatment - Patient satisfaction will be evaluated using the Client Satisfaction Questionnaire (CSQ-8) (Attkisson and Zwick 1982). The CSQ-8 is an 8 item instrument, available in Vietnamese and Arabic, with demonstrated reliability and excellent internal consistency for evaluating satisfaction with health services.
Timepoint [2] 298681 0
Calculated at end point - 3 months following treatment commencement.
Primary outcome [3] 298682 0
Feasibility data - 1) The number of referrals screened, 2) the number meeting the inclusion criteria, 3) the number that agree to be randomised, 4) the number of drop out's and 5) the number that attend the final outcome assessment.
Timepoint [3] 298682 0
1, 2, and 3 will be collected during the recruitment phase, each time a new referral is assessed until the target sample is achieved.
4) Will be evaluated each week, from the start of treatment to treatment conclusion at 3 months, to assess if any participants withdraw of fail to attend their sessions
5) Will be assessed at treatment conclusion (3 months)

Secondary outcome [1] 324947 0
The six minute walk test (6MWT). The 6MWT is a reliable and valid tool that has been used to detect changes in functional performance following exercise-based interventions.
Timepoint [1] 324947 0
Baseline assessment (pre-randomisation) and end point - 3 months following treatment commencement.
Secondary outcome [2] 324948 0
Physical function as measured using the one-minute sit to stand test.
Timepoint [2] 324948 0
Baseline (pre-randomisation) and 3 months following treatment commencement.
Secondary outcome [3] 324949 0
The Pictorial Representation of Illness and Self-Measure (PRISM). The PRISM a reliable pictorial tool to measure the burden of suffering due to an illness and has been validated for use with a range of chronic conditions including chronic pain (Kassardjian, Gardner-Nix et al. 2008).
Timepoint [3] 324949 0
Baseline (pre-randomisation) and 3 months following treatment commencement.
Secondary outcome [4] 324950 0
The Brief Pain Inventory
Timepoint [4] 324950 0
Baseline (pre-randomisation) and 3 months following treatment commencement.
Secondary outcome [5] 324951 0
The Depression, Anxiety and Stress Scale (DASS).
Timepoint [5] 324951 0
Baseline (pre-randomisation) and 3 months following treatment commencement.
Secondary outcome [6] 324952 0
Physiotherapist adherence to evidence based principles in the usual care arm. This will be calculated as the percentage of core components used by the physiotherapist over the treatment period. This will be calculated from therapist treatment diaries.
Timepoint [6] 324952 0
End point - 3 months following treatment commencement.

Eligibility
Key inclusion criteria
1) Referred to physiotherapy for treatment of their chronic pain condition
2) Self-identifying as Vietnamese, Mandaean or Assyrian
3) 18 years of age or older
4) Diagnosis of non-specific musculoskeletal pain
5) Pain that has lasted more than 3 months
6) Agree to participate in physiotherapy treatment and able to attend a pain management program if randomised to this treatment arm.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Specific diagnoses necessitating other treatment such as complex regional pain syndrome, radiculopathy, wait listed for surgery for their pain condition or complex psychological disorders,
2) Surgery within the last 3 months
3) Patients requiring assistance for mobility including the use of an aid other than a walking stick.

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)
The randomisation schedule will be prepared by an independent investigator not involved in participant recruitment or the delivery of interventions. Labelled pieces of paper with the intervention arm will be placed in sealed opaque envelopes according to the random sequence. The envelopes will be labelled with a participant number according to their entry sequence in the study. The envelopes will be managed by a central administrative officer at one site and kept in a secure location. This officer will be contacted once a participant is consented and will be responsible for allocating to the treatment arm and arranging an initial appointment with the appropriate physiotherapist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random allocation will be used to allocate participants into each group. A computer generated sequence with a 1:1 allocation ratio will be used for each ethnocultural community to ensure equal numbers of Assyrian, Mandaean and Vietnamese participants are included in each treatment arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS). A baseline table (descriptive statistics and frequencies) will compare the demographic and clinical characteristics between the two arms. An independent samples t-test will be used to determine the significance of any differences between the two groups at baseline. Data for feasibility will be analysed using descriptive statistics. The percentage of participants who (1) meet the inclusion criteria, (2) agree to be randomised, (3) complete the intervention and (4) attend the follow-up assessment will be calculated. Feasibility will be measured as (1) the number of sessions attended by each participant, (2) number of drop-outs in each group, (3) proportion of participants recruited from the total number screened, and (4) the number of home exercise sessions completed. Acceptability of the novel protocol will be measured using the CSQ-8 and satisfaction between groups assessed using an independent samples t-test.

To determine trends of effectiveness a between groups comparison for the change in each secondary outcome measure over time will be analysed using a repeated measures analysis of variance (ANOVA). Repeated measures ANOVA will be used with factors of intervention (usual care/culturally adapted intervention) and time (pre-intervention/post-intervention). Intention to treat analysis will be used and a will be set at 0.05. The data will be used to generate between group means and variances to inform a future RCT.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6003 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 6004 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 13425 0
2170 - Liverpool
Recruitment postcode(s) [2] 13426 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 293878 0
Charities/Societies/Foundations
Name [1] 293878 0
Physiotherapy Research Foundation
Address [1] 293878 0
Physiotherapy Research Foundation National Office
PO Box 437 Hawthorn BC VIC 3122 Australia
Country [1] 293878 0
Australia
Funding source category [2] 293933 0
Hospital
Name [2] 293933 0
Liverpool Hospital
Address [2] 293933 0
Liverpool Hospital
Locked Bag 7103
Liverpool BC, NSW, 1871
Country [2] 293933 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Liverpool Hospital
Department of Pain Medicine
Locked Bag 7103
LIVERPOOL BC NSW 1871
Country
Australia
Secondary sponsor category [1] 292707 0
University
Name [1] 292707 0
Western Sydney University
Address [1] 292707 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country [1] 292707 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295306 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 295306 0
Research and Ethics Office
Locked Bag 7103, Liverpool BC
NSW, 1871
Ethics committee country [1] 295306 0
Australia
Date submitted for ethics approval [1] 295306 0
26/04/2016
Approval date [1] 295306 0
13/06/2016
Ethics approval number [1] 295306 0
HREC/16/LPOOL/194
Ethics committee name [2] 295337 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [2] 295337 0
Locked Bag 1797
Penrith, NSW
2751
Ethics committee country [2] 295337 0
Australia
Date submitted for ethics approval [2] 295337 0
21/06/2016
Approval date [2] 295337 0
24/06/2016
Ethics approval number [2] 295337 0
RH11741

Summary
Brief summary
Primary aim:
The aim of this project is to pilot a culturally adapted physiotherapy assessment and treatment approach for use with three CALD communities living in Australia and contrast it with ‘usual’ evidence based physiotherapy care. This project will seek to identify aspects of trial design that may need to be modified in a larger RCT. This includes establishing community acceptance and satisfaction with the novel treatment approaches and determining community willingness to participate in randomised research. It will also generate outcome data that will be used for sample size estimates and predicting the magnitude of treatment effects for a future clinical trial.

Hypothesis
It is hypothesised that the culturally adapted approaches will be well accepted by participants and significantly more effective at improving function, burden of suffering and patient adherence, when compared to usual care.

Proposed research design
Pilot Randomised Controlled Trial. Two group pre-test, post-test design.

Methods:
Potential participants will be identified from physiotherapy wait-lists and assessed to ascertain eligibility for trial inclusion. Those who meet the inclusion criteria and consent to participate will be randomly assigned to either the culturally adapted physiotherapy treatment or evidence based usual physiotherapy care.
The culturally adapted physiotherapy treatment approach will be a combination of group physiotherapy education and exercise, and individual treatment. Participants allocated to this treatment arm will attend a group session for two hours a week, for six weeks and up to four individual sessions over three months with a qualified physiotherapist.
The control group is evidence based usual care and will include treatment by a qualified physiotherapist who has not been trained in cultural adaptation methods. Participants randomised to this treatment arm will attend up to ten physiotherapy sessions that incorporate evidenced based physiotherapy management, over three months.
Data that will help determine the feasibility of future trials will be collected including recruitment rates, drop-out rates, adherence and patient satisfaction will be collected at three months. Physical performance outcomes (six minute walk distance and the number of sit to stand’s performed in 1 minute) and pain related questionnaires (Brief Pain Inventory, Pictorial Representation of Illness and Self-Measure, Depression Anxiety and Stress Scale) will collected at pre and post treatment to inform treatment efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66766 0
Ms Bernadette Brady
Address 66766 0
Department of Pain Medicine
Liverpool Hospital
Locked Bag 7103, Liverpool BC
NSW, 1871
Country 66766 0
Australia
Phone 66766 0
+61 2 87387200
Fax 66766 0
Email 66766 0
bernadette.brady@sswahs.nsw.gov.au
Contact person for public queries
Name 66767 0
Ms Bernadette Brady
Address 66767 0
Department of Pain Medicine
Liverpool Hospital
Locked Bag 7103, Liverpool BC
NSW, 1871
Country 66767 0
Australia
Phone 66767 0
+61 2 87387200
Fax 66767 0
Email 66767 0
bernadette.brady@sswahs.nsw.gov.au
Contact person for scientific queries
Name 66768 0
Miss Bernadette Brady
Address 66768 0
Department of Pain Medicine
Liverpool Hospital
Locked Bag 7103, Liverpool BC
NSW, 1871
Country 66768 0
Australia
Phone 66768 0
+61 2 87387200
Fax 66768 0
Email 66768 0
bernadette.brady@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary