Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000230651
Ethics application status
Approved
Date submitted
19/02/2014
Date registered
4/03/2014
Date last updated
13/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Hip Osteoarthritis: effect of combining Pain coping skills training with Exercise and education - HOPE trial
Scientific title
Effect of exercise, education and pain coping skills training on hip pain and physical function in people with persistent hip pain: HOPE trial
Secondary ID [1] 283853 0
NIL
Universal Trial Number (UTN)
U1111-1151-8587
Trial acronym
HOPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hip pain 290830 0
Condition category
Condition code
Musculoskeletal 291195 291195 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 291619 291619 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Pain coping skills training (PCST) delivered on-line combined with general online education followed by physiotherapist prescribed home exercises.

PCST program will be completed in weeks 1-8. Participants will complete on-line pain coping skills training (PCST) in the form of the PainCOACH program consisting of 8 interactive modules, each taking approximately 45 minutes. Participants will be asked to complete one module per week. At the completion of the 8 week modules participants will be asked to continue applying their pain coping skills. Pain coping skills training will be monitored using a PainCOACH specific logbook.

General Education will be received in weeks 1-8. The on-line education component will consist of short fact sheets. These will be presented once a week and will cover topics such as what is OA, healthy eating, importance of exercise, sleep etc. They will take approximately 5 minutes to read.

Participants will attend 5 x 30 minute physiotherapy guided exercise sessions, between weeks 8-24 (approximately one every 3 weeks). The session will focus on developing a home exercise program focused on hip muscle strength and hip joint range of motion. The home exercise program, developed by the project physiotherapist should consist of 4-6 exercises and take approximately 15 minutes to complete. Home exercises are to be completed three times per week from week 8 to week 52. Home exercise practice will be recorded by participants in a log book.
Intervention code [1] 288532 0
Behaviour
Intervention code [2] 288850 0
Rehabilitation
Comparator / control treatment
General online education followed by physiotherapy prescribed home exercise therapy.

General online education and physiotherapy guided exercise is the same as in the intervention group as described above.
Control group
Active

Outcomes
Primary outcome [1] 291185 0
Average walking hip pain - Numeric rating scale
Timepoint [1] 291185 0
Baseline, 8, 24 and 52 weeks after baseline
Primary outcome [2] 291186 0
Self reported physical function - Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC)
Timepoint [2] 291186 0
Baseline, 8, 24 and 52 weeks after baseline
Secondary outcome [1] 306199 0
Global rating of change. Participant perceived response to treatment - Participants will rate their perceived change in pain, physical function and change overall with treatment (compared to baseline) on a 7-point ordinal scale.
Timepoint [1] 306199 0
Baseline, 8, 24 and 52 weeks after baseline
Secondary outcome [2] 306200 0
Self reported pain - Pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC)
Timepoint [2] 306200 0
Baseline, 8, 24 and 52 weeks after baseline
Secondary outcome [3] 306201 0
Habitual physical activity - Physical activity for the elderly (PASE)
Timepoint [3] 306201 0
Baseline, 8, 24 and 52 weeks after baseline
Secondary outcome [4] 306202 0
Health related quality of life assessed using the Quality of Life instrument version 2 (AQoLII)
Timepoint [4] 306202 0
Baseline, 8, 24 and 52 weeks after baseline
Secondary outcome [5] 306203 0
Self reported psychological measures

Arthritis Self Efficacy Scale
Pain Catastrophising Scale
Coping Strategies Questionnaire
Depression, Anxiety and Stress (DASS-21) Questionnaire
Timepoint [5] 306203 0
Baseline, 8, 24 and 52 weeks after baseline

Eligibility
Key inclusion criteria
Persistent hip pain for more than 3 months and for most days of the past month

Self-reported average walking pain level over the past week of equal to or greater than 4 out of 10 on a numeric rating scale

Ability to travel to one of the study Physiotherapy clinics

Current email address and access to a computer with broadband internet connection

Able to commit approximately 12 months to the study
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hip joint replacement on the painful side

Knee replacement on either side within the previous 6 months

Planning hip joint or knee surgery within the past/next 12 months

Current or past (within 3 months) oral or intra-articular corticosteroid use

Systemic arthritic conditions

Self-reported high-level depression (score of >21 on the depression subscale of the Depression, Anxiety and Stress Scale (DASS-21)

Other muscular, joint or neurological condition affecting lower limb function

Undertaken a previous behavioural treatment program in the past 12 months

Physiotherapy treatment or exercises specifically for the back, hip and knee in past 6 months

Unable to comply with protocol

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)
A trained research assistant will conduct telephone screening of volunteers. Eligible consenting participants will complete baseline questionnaires online following which they will be randomised into one of two treatment groups: (i) control: exercise and on-line education; or (ii) intervention: exercise and on-line education plus on-line PCST “PainCOACH”.
To conceal randomization, consecutively numbered, sealed, opaque envelopes will be prepared by a researcher with no other involvement in the study. The envelopes will be stored in a locked location and will be opened in sequence to reveal group allocation by a different researcher not involved in the sequence generation or concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the study biostatistician. Randomisation will be by random permuted blocks of varying size stratified according to therapist (to control for therapist variation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The minimum clinically important difference in OA trials is a change in pain of 1.8 units and a change of six physical function WOMAC units (out of 68). Based on our previous data from a RCT of a physiotherapy intervention for hip OA, we assumed a between-participant standard deviation of 1.2 for pain and 8.8 units for physical function, and a baseline to week 24 follow-up correlation of 0.45 for pain and 0.35 for physical function. The required sample size for analysis of covariance of change controlling for the baseline value with power set at 90%, and type I error at .05 is 59 participants per group for physical function and 11 per group for pain. To be adequately powered for both primary outcomes and allowing for an approximate 20% drop-out rate, we will recruit 71 participants per group.

Our biostatistician will analyse the data in a blinded manner. Main comparative analyses between groups will be performed using an intention-to-treat analysis. For continuous outcomes (eg pain, physical function), differences in mean change (follow-up minus baseline) will be compared between groups using linear regression modelling adjusted for baseline values of the outcome. The proportion of 'improved' participants in each group will be compared using the relative risk (RR) from a generalised linear binomial model with a log link. We will also perform a per protocol analysis as appropriate. Linear regression modelling will assess relationships between psychological factors and treatment outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
27/03/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
14/04/2015
Date of last data collection
Anticipated
Actual
9/05/2016
Sample size
Target
142
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 288503 0
Government body
Name [1] 288503 0
National Health and Medical Research Council
Country [1] 288503 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Victoria 3010
Australia
Country
Australia
Secondary sponsor category [1] 287208 0
None
Name [1] 287208 0
Address [1] 287208 0
Country [1] 287208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290361 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 290361 0
Melbourne Research
The University of Melbourne
Level 5, Alan Gilbert Building
VIC 3010
Ethics committee country [1] 290361 0
Australia
Date submitted for ethics approval [1] 290361 0
28/10/2013
Approval date [1] 290361 0
20/12/2013
Ethics approval number [1] 290361 0
1341124.1

Summary
Brief summary
Persistent hip pain in individuals over 50 years of age is most often due to underlying hip osteoarthritis (OA). Hip osteoarthritis (OA) is a chronic musculoskeletal condition causing pain, physical dysfunction, psychological impairments and reduced quality-of-life. There is currently no cure, thus hip OA is a major public health problem contributing to substantial patient morbidity, health care costs and lengthy surgical waiting lists.

Although exercise is recommended by all clinical guidelines for managing hip OA, clinical trials have shown that exercise is either not effective or has only modest benefits. Exercise, typically aimed at addressing muscle strength deficits and restricted joint range of motion, does not directly address psychological factors that are significantly increased in people with hip OA and are associated with higher pain levels and poorer function. Pain coping skills training (PCST), a form of cognitive behavioural therapy, is effective but its clinical application is limited because of poor access to appropriately-trained health professionals and high treatment costs. There is an urgent need to evaluate alternate delivery methods of PCST as an adjunctive treatment to exercise in OA.

There are no studies in hip OA that have evaluated the efficacy of PCST (or any other behavioural intervention) either alone, or combined with biomedical treatments such as exercise.

This study has two main aims comparing two interventions; Intervention A = Online general education and online PCST, followed by exercise, compared to Intervention B = online education, followed by exercise. In both interventions exercise commences in week 8, on completion of the online educational component. Both interventions are assessed at two separate time points, week 24 and week 8. The first aim is to assess and compare at 24 weeks the effect of the two interventions on pain and physical function. The second aim is to assess and compare the effect of Intervention A and B on pain and physical function prior to the commencement of exercise which is introduced in week 8 in both groups.
Trial website
Trial related presentations / publications
Trial is currently under consideration for publication.
Public notes

Contacts
Principal investigator
Name 45330 0
Prof Kim Bennell
Address 45330 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Alan Gilbert Building
Victoria 3010
Country 45330 0
Australia
Phone 45330 0
+ 61 3 83444135
Fax 45330 0
Email 45330 0
[email protected]
Contact person for public queries
Name 45331 0
Miss Rachel Nelligan
Address 45331 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Alan Gilbert Building
Victoria 3010
Country 45331 0
Australia
Phone 45331 0
+61 3 8344 9411
Fax 45331 0
Email 45331 0
[email protected]
Contact person for scientific queries
Name 45332 0
Prof Kim Bennell
Address 45332 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Alan Gilbert Building
Victoria 3010
Country 45332 0
Australia
Phone 45332 0
+ 61 3 83444135
Fax 45332 0
Email 45332 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.2015https://dx.doi.org/10.2522/ptj.20150119
N.B. These documents automatically identified may not have been verified by the study sponsor.