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Trial registered on ANZCTR


Registration number
ACTRN12614000243617
Ethics application status
Approved
Date submitted
19/02/2014
Date registered
7/03/2014
Date last updated
12/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet Mediated physiotherapy and Pain Coping skills Training for people with persistent knee pain - IMPACT trial
Scientific title
Effect of internet mediated physiotherapy and pain coping skills training on pain and physical function in people with persistent knee pain - IMPACT trial
Secondary ID [1] 284110 0
Nil
Universal Trial Number (UTN)
U1111-1153-4642
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent knee pain 291188 0
Condition category
Condition code
Musculoskeletal 291523 291523 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 291616 291616 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
13 week intervention: A package of on-line pain coping skills training (PCST), physiotherapy guided exercise delivered on-line via SKYPE and on-line general education. On-line pain coping skills training and online general education will commence in week 1. Physiotherapy SKYPE sessions will commence after this in week 2 in order for participants to complete 1-2 PainCOACH sessions prior to commencing the physiotherapy intervention.

PCST program - 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.

General education made available on-line - The on-line education component will consist of short fact sheets covering topics such as what is OA, healthy eating, importance of exercise, sleep etc. There will be 18 fact sheets in total which will be available to access online through a password protected site. There is no required access schedule. Participants may access the fact sheets at any time throughout the duration of the trial, 36weeks. They will take approximately 5 minutes each to read.

Physiotherapy guided exercise delivered on-line via SKYPE - participants will complete 7 Physiotherapy exercise based sessions using Skype over the 13 week intervention, commencing in week 2 at intervals of approximately 2 weeks. Session one will be 45 minutes in duration and all subsequent sessions will be 30 minutes. Participants will be prescribed a home exercise program of 4-6 exercises for knee strength and range of motion. Home exercises are to be completed 3 times a week and will take approximately 15 minutes. Participants will commence their home exercise program in week 2 and are encouraged to continue their exercise program until the end of the trial at 36 weeks.
We will monitor adherence to the home exercise program through participant log books. Pain coping skills training will be monitored using a PainCOACH specific logbook.
Intervention code [1] 288804 0
Rehabilitation
Comparator / control treatment
General on-line education as made available to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 291493 0
Average walking knee pain in the past week - 11 point numeric rating scale
Timepoint [1] 291493 0
13 weeks
Primary outcome [2] 291494 0
Physical function - WOMAC Osteoarthritis Index physical function subscale
Timepoint [2] 291494 0
13 weeks
Secondary outcome [1] 306895 0
Overall pain - WOMAC Osteoarthritis Index pain subscale
Timepoint [1] 306895 0
13weeks
Secondary outcome [2] 306896 0
Perceived change overall - 7 point ordinal scale
Timepoint [2] 306896 0
13 weeks
Secondary outcome [3] 306897 0
Perceived change in pain - 7 point ordinal scale
Timepoint [3] 306897 0
13 weeks
Secondary outcome [4] 306898 0
Perceived change in function - 7 point ordinal scale
Timepoint [4] 306898 0
13 weeks
Secondary outcome [5] 306899 0
Health related quality of life - AQoL2 questionnaire
Timepoint [5] 306899 0
13 weeks
Secondary outcome [6] 306900 0
Self reported psychological measures:

Arthritis Self Efficacy Scale
Coping Strategies Questionnaire
Pain Catastrophising Scale
Depression, Anxiety and Stress (DASS-21) Questionnaire
Timepoint [6] 306900 0
13 weeks

Eligibility
Key inclusion criteria
Aged 50 years and over

Persistent knee 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

WOMAC physical function score of >20 (at least mild-moderate dysfunction)

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

Able to commit approximately 12 months to the study and willing to do regular home exercises and pain coping skills training practice if allocated to the combined intervention or education only groups.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have had or on the waiting list for a knee or hip joint replacement on the painful knee side

Have had or are planning knee joint surgery, intra-articular injection therapy on the painful knee within the past/next 6 months

Have seen a health practitioner and had treatment (e.g. physiotherapy, chiropractic, osteopathy, acupuncture etc) for knee pain, or participated in a muscle strengthening exercise program or a pain coping skills program, in the past 6 months

Systemic arthritic condition

Any neurological conditions such as a stroke, Multiple sclerosis, polio, neuropathy, peripheral nerve disease or Parkinson’s disease that affects the lower-limb and limits the ability to exercise safely

Any other major joint pain (e.g. back, hip or ankle) that currently limits the ability to exercise

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

People without a good level of written and spoken English

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: on-line education alone; or (ii) intervention: on-line PCST “PainCOACH”, exercise based physiotherapy delivered on skype and general on-line education.

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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary endpoint of the trial is change in knee pain on walking (NRS) and change in physical function (WOMAC) between the combined treatment group and the control group. Sample size calculations are based on a two-arm trial with 80% power and significance level at 0.05. The minimum clinically important difference to be detected in OA trials is a change in pain of 1.8 units (out of 10) 32 and change in function of 6 points (out of 68) 33. Based on data from our recently completed RCT of face-to-face physiotherapist-delivered exercise and PCST with a comparable patient population in 67 people with chronic knee pain), we estimate a between-participant standard deviation of 2.2 for pain and 11.0 for WOMAC physical function and a baseline to 6-month correlation in scores of 0.29 for pain and 0.51 for physical function. Using these estimates would enable the detection of treatment effects of 0.8 for pain and 0.55 for function. As smaller treatment effects of around 0.5 have also been found for pain and function following individual exercise programs in people with knee OA, this study will be adequately powered to also detect these smaller effect sizes. Therefore allowing for 15% attrition rate, to enable the detection of at least a 0.5 effect size in either pain or function, we will recruit 74 participants in each group or a total of 148 participants.

Our biostatistician will analyse data in a blinded manner. Main comparative analyses between groups will be performed using intention-to-treat. For continuous outcomes (e.g. pain, physical function), differences in mean change (baseline minus follow-up) will be compared between groups using linear regression modelling adjusted for baseline values of the outcome. Proportional odds models will compare improvement between groups based on perceived ratings of change. We will also perform a per protocol analysis as appropriate. Linear regression modelling will assess associations between treatment group and other follow-up measures at each time-point, adjusted for baseline values. Effects of patient characteristics related to treatment outcomes will be assessed by including relevant terms in the models. Variables will be included if they are significant at the 5% level.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/03/2014
Actual
17/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
148
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 7794 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 288744 0
Government body
Name [1] 288744 0
National Health and Medical Research Council
Country [1] 288744 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Victoria 3010
Country
Australia
Secondary sponsor category [1] 287439 0
None
Name [1] 287439 0
Address [1] 287439 0
Country [1] 287439 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290577 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 290577 0
Ethics committee country [1] 290577 0
Australia
Date submitted for ethics approval [1] 290577 0
15/04/2013
Approval date [1] 290577 0
20/12/2013
Ethics approval number [1] 290577 0
1339459.1

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

Contacts
Principal investigator
Name 46306 0
Prof Kim Bennell
Address 46306 0
Centre for Health, Exercise and Sports Medicine Department of
Physiotherapy University of Melbourne Alan Gilbert Building Victoria 3010
Country 46306 0
Australia
Phone 46306 0
+ 61 3 83444135
Fax 46306 0
Email 46306 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 46307 0
Fiona Dobson
Address 46307 0
Centre for Health, Exercise and Sports Medicine Department of
Physiotherapy University of Melbourne Alan Gilbert Building Victoria 3010
Country 46307 0
Australia
Phone 46307 0
+61 3 83448802
Fax 46307 0
Email 46307 0
fdobson@unimelb.edu.au
Contact person for scientific queries
Name 46308 0
Kim Bennell
Address 46308 0
Centre for Health, Exercise and Sports Medicine Department of
Physiotherapy University of Melbourne Alan Gilbert Building Victoria 3010
Country 46308 0
Australia
Phone 46308 0
+ 61 3 83444135
Fax 46308 0
Email 46308 0
k.bennell@unimelb.edu.au

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
EmbaseAn online exercise program plus automated coping skills training improved pain and function in chronic knee pain.2017https://dx.doi.org/10.7326/ACPJC-2017-166-12-067
EmbaseEffectiveness of an internet-delivered exercise and pain-coping skills training intervention for persons with chronic knee pain: A randomized trial.2017https://dx.doi.org/10.7326/M16-1714
EmbaseModerators of Effects of Internet-Delivered Exercise and Pain Coping Skills Training for People With Knee Osteoarthritis: Exploratory Analysis of the IMPACT Randomized Controlled Trial.2018https://dx.doi.org/10.2196/10021
N.B. These documents automatically identified may not have been verified by the study sponsor.