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Trial registered on ANZCTR


Registration number
ACTRN12623001323617
Ethics application status
Approved
Date submitted
22/11/2023
Date registered
18/12/2023
Date last updated
31/05/2024
Date data sharing statement initially provided
18/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypermobile Online Pain managemEnt (HOPE) for people with hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): a pilot randomised controlled trial of feasibility, acceptability and effectiveness
Scientific title
Hypermobile Online Pain managemEnt (HOPE) for people with hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): a pilot randomised controlled trial of feasibility, acceptability and effectiveness
Secondary ID [1] 311013 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypermobile Ehlers-Danlos Syndrome (hEDS) 332123 0
Hypermobility Spectrum Disorder (HSD) 332124 0
Joint Hypermobility Syndrome 332125 0
Ehlers-Danlos Syndrome - Hypermobile Type 332126 0
Condition category
Condition code
Musculoskeletal 328852 328852 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online pain management program for hEDS or HSD (HOPE program). The content in this program were developed based on a previous modified Delphi study of participants with the conditions and healthcare professionals who have experience treating the conditions. We are in the process of preparing as a manuscript for submission and it has not been published, we are therefore unable to provide a reference. The HOPE program is an online, 12 modules, 30-45 minutes each module, 2 modules/week program. Participants read through word content including topics like pain neuroscience education, medical and conservative pain management strategies, and lifestyle and behavioural suggestions. There are images and some downloadable pdf files to supplement the word content. Most modules have reflective questions that participants can choose to answer that prompts them reflect on their own pain experiences and to create their own pain action plans. Participants will have access to the program for 8 weeks (2 weeks extra in case they need it, for example due to unexpected health problems). They will be given a login name and password. Participants can access the program at their own time (self-paced) and in their location of choice over 8 weeks. They will also be allowed to continue treatment-as-usual for their pain. After 8 weeks, their access to the program will be discontinued.
Intervention code [1] 327450 0
Rehabilitation
Intervention code [2] 327451 0
Lifestyle
Intervention code [3] 327452 0
Behaviour
Comparator / control treatment
The treatment-as-usual (control) group will not receive the intervention, instead, they will be encouraged to continue their usual treatments for the pain due to their condition. Usual treatment may consist of treatment such as regular pain medication, regular allied health interventions for pain (such as physiotherapy, massage therapy, clinical psychology), exercise.
Control group
Active

Outcomes
Primary outcome [1] 336646 0
Feasibility
Timepoint [1] 336646 0
At post-completion of intervention (T1)
Primary outcome [2] 336647 0
Acceptability
Timepoint [2] 336647 0
At post-completion of intervention (T1)
Primary outcome [3] 336648 0
Appropriateness
Timepoint [3] 336648 0
At post-completion of intervention (T1)
Secondary outcome [1] 429156 0
Change in use of pain medication and/or other healthcare pain treatment (such as GP, pain specialist, physiotherapy, psychology) over the course of the intervention period
Timepoint [1] 429156 0
At post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [2] 429157 0
Pain
Timepoint [2] 429157 0
at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [3] 429158 0
Impact of joint hypermobility
Timepoint [3] 429158 0
at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [4] 429159 0
Depression
Timepoint [4] 429159 0
at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [5] 429160 0
Impression of change
Timepoint [5] 429160 0
At post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [6] 429161 0
Self-efficacy
Timepoint [6] 429161 0
at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [7] 429162 0
Adverse event
Timepoint [7] 429162 0
at post-completion of intervention (T1)
Secondary outcome [8] 429163 0
Participant expectation of change in pain outcome following intervention (Minimal clinically important difference, MCID of the Brief Pain Inventory - Short Form (BPI-SF) score)
Timepoint [8] 429163 0
at pre-intervention (T0), at post-completion of intervention (T1)
Secondary outcome [9] 429652 0
Anxiety
Timepoint [9] 429652 0
at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [10] 429653 0
Stress
Timepoint [10] 429653 0
at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
Secondary outcome [11] 430028 0
Participant expectation of change in impact of hypermobility outcome following intervention (Minimal clinically important difference, MCID of the Bristol Impact of Hypermobility (BIoH))
Timepoint [11] 430028 0
at pre-intervention (T0), at post-completion of intervention (T1)
Secondary outcome [12] 430029 0
Participant expectation of change in depression outcome following intervention (Minimal clinically important difference, MCID of the Depression, Anxiety and Stress Scale (DASS-21))
Timepoint [12] 430029 0
at pre-intervention (T0), at post-completion of intervention (T1)
Secondary outcome [13] 430030 0
Participant expectation of change in anxiety outcome following intervention (Minimal clinically important difference, MCID of the Depression, Anxiety and Stress Scale (DASS-21))
Timepoint [13] 430030 0
at pre-intervention (T0), at post-completion of intervention (T1)
Secondary outcome [14] 430031 0
Participant expectation of change in stress outcome following intervention (Minimal clinically important difference, MCID of the Depression, Anxiety and Stress Scale (DASS-21))
Timepoint [14] 430031 0
at pre-intervention (T0), at post-completion of intervention (T1)
Secondary outcome [15] 430032 0
Participant expectation of change in global impression of change following intervention (Minimal clinically important difference, MCID of the Patient Global Impression of Change (PGIC))
Timepoint [15] 430032 0
at pre-intervention (T0), at post-completion of intervention (T1)
Secondary outcome [16] 430033 0
Participant expectation of change in pain self-efficacy following intervention (Minimal clinically important difference, MCID of the Patient Self-Efficacy Questionnaire (PSEQ))
Timepoint [16] 430033 0
at pre-intervention (T0), at post-completion of intervention (T1)

Eligibility
Key inclusion criteria
• Adults aged 18 and over
• Australian residents
• Diagnosed with hEDS or HSD or Joint Hypermobility Syndrome (JHS) or Ehlers-Danlos Syndrome – Hypermobility Type (EDS-HT) by a medical doctor (e.g. rheumatologist, geneticist, general practitioner)
• Presence of pain for more than 3 months
• Sufficient English proficiency to engage with program and interview
• Have access to a desktop/laptop and internet over the course of the program
• Stable dosage and type of pain medication in the last 3 months
• Stable medical or allied health interventions for pain (such as Physiotherapy, Psychology) in the last 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe depression (Patient Health Questionnaire (PHQ-9) score >=20)
• Significant suicidal ideation (PHQ-9 score >2 on item 9)
• Co-existing medical conditions causing pain not known to be associated with hEDS/HSD such as active cancer, active inflammatory joint conditions

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)
Allocation is concealed. We were able to perform allocation concealment by having member A (not involved in the recruitment) create the allocation sequence via an online sequence generator, and another member B (involved in the recruitment but blinded to the allocation sequence) would ask member A for an allocation each time a participant was enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into either control group or intervention group using a permuted block randomisation, using a computer-generated random sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
30/01/2024
Date of last participant enrolment
Anticipated
30/04/2024
Actual
13/03/2024
Date of last data collection
Anticipated
4/10/2024
Actual
Sample size
Target
70
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315276 0
University
Name [1] 315276 0
Macquarie University
Country [1] 315276 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Ground floor, 75 Talavera Road, Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 317313 0
None
Name [1] 317313 0
Address [1] 317313 0
Country [1] 317313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314195 0
Macquarie University HREC Medical Sciences Committee
Ethics committee address [1] 314195 0
Ethics committee country [1] 314195 0
Australia
Date submitted for ethics approval [1] 314195 0
14/10/2023
Approval date [1] 314195 0
21/11/2023
Ethics approval number [1] 314195 0
520231630154261

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

Contacts
Principal investigator
Name 130750 0
A/Prof Cliffton Chan
Address 130750 0
Ground Floor, 75 Talavera Rd, Macquarie University, NSW 2109, Australia
Country 130750 0
Australia
Phone 130750 0
+61 2 98506618
Fax 130750 0
Email 130750 0
[email protected]
Contact person for public queries
Name 130751 0
Cliffton Chan
Address 130751 0
Ground Floor, 75 Talavera Rd, Macquarie University, NSW 2109, Australia
Country 130751 0
Australia
Phone 130751 0
+61 2 98506618
Fax 130751 0
Email 130751 0
[email protected]
Contact person for scientific queries
Name 130752 0
Cliffton Chan
Address 130752 0
Ground Floor, 75 Talavera Rd, Macquarie University, NSW 2109, Australia
Country 130752 0
Australia
Phone 130752 0
+61 2 98506618
Fax 130752 0
Email 130752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified outcome measures
When will data be available (start and end dates)?
Data will be made available in the Macquarie University data repository within 18 months after publication in a peer-reviewed journal, with no end date
Available to whom?
Data is open and will be licensed CC-BY International 4.0, requiring citation.
Available for what types of analyses?
Any analyses but subject to consultation with Principal Investigator
How or where can data be obtained?
Macquarie Research Data Repository and correspondence with Principal Investigator Cliffton Chan (email address: [email protected], phone +61 2 9850 6618)


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.