Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000533099
Ethics application status
Approved
Date submitted
26/05/2010
Date registered
1/07/2010
Date last updated
26/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and Cognitive Behavioural Therapy for Knee Osteoarthritis
Scientific title
Addressing pain in knee osteoarthritis: physiotherapist-delivered exercise and cognitive behavioural therapy.
Secondary ID [1] 251924 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 257468 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257619 257619 0 0
Physiotherapy
Mental Health 257620 257620 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 257801 257801 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To investigate the benefits of a 12-week intervention involving 10 weekly treatment sessions delivered by a physiotherapist on a one-to-one basis.
This is a 12 week intervention because prior to meeting the physiotherapist at week 1 and week 12 the participant will attend the university for laboratory assesssment and we will request that the participant wear a pedometer for 7 days straight and record the number of steps they have taken on a data collection sheet during both periods. They will see the physiotherapist from weeks 2-11.

The study will examine the effectiveness of a combined exercise and Cognitive Behavioural Therapy (CBT) intervention compared to each intervention (CBT or Exercise) alone. All interventions will be delivered by a sole health care professional - specially trained physiotherapists. This means that the exercise and CBT components can be integrated and delivered in the same session.

Intervention Groups:

i) Exercise Alone - 25 minute treatment sessions X 10 sessions

This component is comprised of:
-quadraceps strengthening
-sitting knee extension
-hip abductor strengthening
-partial wall squats
-sit to stand exercise
-hamstring strengthening
-step up and step down exercise

ii) CBT Alone - 45 minute treatment sessions X 10 sessions

This component is comprised of:
-explanation of the gate control theory
-progressive muscle relaxation
-relaxation training and and explanation of its benefits
-identifying and challenging negative thoughts
-problem solving
-pleasant imagery and counting backwards

iii) CBT plus Exercise - 70 minute treatment sessions X 10 sessions

This component is comprised of a combination of i) & ii) above.
Intervention code [1] 256562 0
Rehabilitation
Intervention code [2] 256563 0
Behaviour
Intervention code [3] 256564 0
Treatment: Other
Comparator / control treatment
The groups are comprised of either CBT Alone, Exercise Alone or CBT & Exercise Combined.

There is no control group.
Control group
Active

Outcomes
Primary outcome [1] 258530 0
The primary outcome will be knee pain measured by the Visual analogue scale (VAS).
Timepoint [1] 258530 0
Baseline, 12, 32 and 52 weeks (post treatment)
Primary outcome [2] 258531 0
Self-report physical function subscale-Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
Timepoint [2] 258531 0
Baseline, 12, 32 and 52 weeks (post treatment)
Secondary outcome [1] 264362 0
Psychological parameters:
-Anxiety Subscale of the Arthritis Impact Measurement Scales (AIMS II)
Timepoint [1] 264362 0
Baseline, 12, 32 and 52 weeks (post treatment)
Secondary outcome [2] 264363 0
Physical parameters:

-Step Test
Timepoint [2] 264363 0
Baseline, Week 12, and at 52 weeks (post treatment)
Secondary outcome [3] 264364 0
Participant global rating of change questionnaire
Timepoint [3] 264364 0
Weeks 12, 32 and 52 (post treatment)
Secondary outcome [4] 264365 0
Physical activity levels and attitudes to exercise:

-Physical Activity Scale for the Elderly (PASE)
Timepoint [4] 264365 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [5] 264648 0
Pedometers:
-All participants will be asked to wear a pedometer for 7 days at each time point to assess the number of walking steps they take.
Timepoint [5] 264648 0
Baseline, Week 12, 32 and at 52 weeks (post treatment)
Secondary outcome [6] 264649 0
Attitudes and barriers to exercise:
-Self-Regulation Scale
Timepoint [6] 264649 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [7] 264650 0
The Self-Efficacy for Physical Activity Scale
Timepoint [7] 264650 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [8] 264651 0
The Benefits of Physical Activity Scale
Timepoint [8] 264651 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [9] 264652 0
Treatment Credibility Scale
-Participants will rate treatment credibility after the first and last session.
Timepoint [9] 264652 0
Treatment Credibility Scale-Weeks 1 and 12
Secondary outcome [10] 264653 0
Adherence
A logbook will be completed by all participants to record -adherence with the home programs.
Timepoint [10] 264653 0
Weeks 1-12
Secondary outcome [11] 264654 0
Health Related Quality of Life:
-Assesment of Quality of Life (AQoL II)
Timepoint [11] 264654 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [12] 264655 0
Patient Health/medications/co-interventions questionnaire
Timepoint [12] 264655 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [13] 264656 0
Self Efficacy:
-The Arthritis Self Efficacy Scale:
Timepoint [13] 264656 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [14] 264657 0
Pain catastrophising:
-The 13-item Pain Catastrophizing Scale.
Timepoint [14] 264657 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [15] 264658 0
Use of coping skills to manage pain:
-Coping Attempts Scale of the Coping Strategies Questionnaire.
Timepoint [15] 264658 0
Baseline, Week 12, 32 weeks and at 52 weeks (post treatment)
Secondary outcome [16] 264659 0
Physical parameters:

-40m Walk Test
Timepoint [16] 264659 0
Baseline, Week 12, and at 52 weeks (post treatment)
Secondary outcome [17] 264660 0
Physical parameters:

-Timed Up and Go Test
Timepoint [17] 264660 0
Baseline, Week 12, and at 52 weeks (post treatment)
Secondary outcome [18] 264661 0
Physical parameters:

-Hip Abduction Strength

Equipment:
Hand held Nicholas Manual Muscle Tester (NMMT)
Tape measure
Plinth
Towel and straps
Timepoint [18] 264661 0
Baseline, Week 12, and at 52 weeks (post treatment)
Secondary outcome [19] 264662 0
Physical parameters:

-Quadracep Strength


Equipment:

-Force gauge with chair attachments
-Suitable chair
-Triangular foam block
-Two straps to secure subject in chair
-Set square to check knee angle and measure lever length



This device was devised to provide a robust approach to isometric strength assessment of the quadriceps and hamstrings, ie superior than what can be achieved with instrumented hand-held dynamometry, but not so complex that it required extensive user training, elaborate apparatus, computer data collection, etc. The device is designed to be attached to a common style of office chair.
Timepoint [19] 264662 0
Baseline, Week 12, and at 52 weeks (post treatment)
Secondary outcome [20] 264663 0
Physical parameters:

-Hamstring Strength


Equipment:

-Force gauge with chair attachments
-Suitable chair
-Triangular foam block
-Two straps to secure subject in chair
-Set square to check knee angle and measure lever length
Timepoint [20] 264663 0
Baseline, Week 12, and at 52 weeks (post treatment)

Eligibility
Key inclusion criteria
-All participants will have knee joint osteoarthritis (OA) in at least one knee fulfilling the American College of Rheumatology classification criteria
- Over 50 years of age
- Pain on most days of the past month a
- Self-reported level of average pain in the past week of greater than or equal to 4 out of 10 on a numeric rating scale
- Greater than or equal to 25 on the WOMAC physical function scale
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-History of lower limb joint replacement
-Surgical waiting list for knee or hip replacement; knee surgery, intra-articular steroid or Synvisc (registered trademark) injection planned or within the past 6 months
-Systemic arthritic condition such as rheumatoid arthritis; received (within 6 months)
-Currently receiving any physiotherapy for knee OA; participation in a formal lower limb exercise program within the past 6 months or planning to commence exercise or other treatment for knee OA in the next 12 months
-Currently walking >15 minutes continuously more than 2 times per week
-Unable to walk without a gait aid
-Self-reported medical condition precluding safe exercise participation (excessive shortness of breath or any underlying condition)
-Previous CBT/pain coping skills training.

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 Project Examiner will conduct preliminary screening over the phone. A standardised knee x-ray will then be obtained. This will be used to determine eligibility and to grade osteoarthritis severity. Baseline testing will be performed following which the participant will be randomised into one of three groups: i) CBT Alone, ii) Exercise Alone, iii) CBT and Exercise. The randomisation schedule will be prepared by the study biostatistician. To conceal randomisation, consecutively numbered, sealed, opaque envelopes will be used and maintained centrally. The envelopes will be kept in a locked location accessible only be a research administrator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a 3-arm randomised controlled trial with a 12-week intervention period and measurements taken at baseline and immediately following the 12-week intervention. Randomization will be conducted by random permuted blocks stratified by site (Melbourne or Brisbane) and gender (Male or Female).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
222
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2934 0
3084
Recruitment postcode(s) [2] 2935 0
3033
Recruitment postcode(s) [3] 2936 0
3134
Recruitment postcode(s) [4] 2937 0
3108
Recruitment postcode(s) [5] 2938 0
3109
Recruitment postcode(s) [6] 2939 0
3196
Recruitment postcode(s) [7] 2940 0
3144
Recruitment postcode(s) [8] 2941 0
3145
Recruitment postcode(s) [9] 2942 0
3088
Recruitment postcode(s) [10] 2943 0
3079
Recruitment postcode(s) [11] 2944 0
3184
Recruitment postcode(s) [12] 2945 0
3741
Recruitment postcode(s) [13] 2946 0
3187
Recruitment postcode(s) [14] 2947 0
3175
Recruitment postcode(s) [15] 2948 0
3128
Recruitment postcode(s) [16] 2949 0
3124
Recruitment postcode(s) [17] 2950 0
3162
Recruitment postcode(s) [18] 2951 0
3101
Recruitment postcode(s) [19] 2952 0
4061
Recruitment postcode(s) [20] 2953 0
4000
Recruitment postcode(s) [21] 2954 0
4072
Recruitment postcode(s) [22] 2955 0
4007
Recruitment postcode(s) [23] 2956 0
4121
Recruitment postcode(s) [24] 2957 0
4053
Recruitment postcode(s) [25] 2958 0
4006
Recruitment postcode(s) [26] 2959 0
4051
Recruitment postcode(s) [27] 2960 0
4031
Recruitment postcode(s) [28] 2961 0
4060

Funding & Sponsors
Funding source category [1] 257062 0
Commercial sector/Industry
Name [1] 257062 0
Australian Health Management
Country [1] 257062 0
Australia
Primary sponsor type
University
Name
The University of Melbourne, School of Physiotherapy
Address
Melbourne School of Health Sciences
Department of Physiotherapy
200 Berkeley Street
Carlton
Melbourne
Victoria 3010
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 256315 0
University
Name [1] 256315 0
The University of Queensland
Address [1] 256315 0
National Health and Medical Research Council (NHMRC) Centre for Clinical Research Excellence in Spinal Pain, Injury and Health
School of Health and Rehab Sciences
The University of Queensland
Brisbane Qld 4072
Country [1] 256315 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259085 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 259085 0
Ethics committee country [1] 259085 0
Australia
Date submitted for ethics approval [1] 259085 0
01/03/2010
Approval date [1] 259085 0
21/04/2010
Ethics approval number [1] 259085 0
1033341
Ethics committee name [2] 259110 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 259110 0
Ethics committee country [2] 259110 0
Australia
Date submitted for ethics approval [2] 259110 0
17/03/2010
Approval date [2] 259110 0
31/03/2010
Ethics approval number [2] 259110 0
2010000340

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

Contacts
Principal investigator
Name 31227 0
Address 31227 0
Country 31227 0
Phone 31227 0
Fax 31227 0
Email 31227 0
Contact person for public queries
Name 14474 0
Professor Kim Bennell
Address 14474 0
The University of Melbourne
Centre for Health, Exercise and Sports Medicine
School of Physiotherapy
200 Berkeley Street
Carlton, Victoria 3010
AUSTRALIA
Country 14474 0
Australia
Phone 14474 0
+61 3 8344 4135
Fax 14474 0
+61 3 8344 3771
Email 14474 0
[email protected]
Contact person for scientific queries
Name 5402 0
Professor Kim Bennell
Address 5402 0
The University of Melbourne
Centre for Health, Exercise and Sports Medicine
School of Physiotherapy
200 Berkeley Street
Carlton, Victoria 3010
AUSTRALIA
Country 5402 0
Australia
Phone 5402 0
+613 8344 4135
Fax 5402 0
+61 3 8344 3771
Email 5402 0
[email protected]

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No Supporting Document Provided



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