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Trial registered on ANZCTR


Registration number
ACTRN12616000337471
Ethics application status
Approved
Date submitted
18/02/2016
Date registered
16/03/2016
Date last updated
8/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Frequency of manual therapy treatment for people with knee osteoarthritis
Scientific title
How does the frequency of manual therapy treatment influence outcome for people with knee osteoarthritis? A feasibility study
Secondary ID [1] 288568 0
None
Universal Trial Number (UTN)
U1111-1179-8313
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 297698 0
Condition category
Condition code
Musculoskeletal 297876 297876 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 298135 298135 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual therapy provided by a physiotherapist at a frequency of once per week for six weeks or twice per week for three weeks. For the once per week group, the target treatment interval will be seven days (minimum six days, maximum nine days). For the twice per week group intervals between treatments will be three or four days (minimum two days, maximum five days). Reasons for not booking appointments on the target day will be recorded, as will the reasons for selection of an alternative day within the acceptable range. If appointments cannot be scheduled within the acceptable range, they will be recorded as "missed", with a reason. Each manual therapy treatment session will last for 45 minutes and include mobilisation of joints by the physiotherapist, and stretching applied to the soft tissues. During the sessions the physiotherapist will deliver a standardised information package including education about osteoarthritis, and advice such as control of body weight and maintenance of regular exercise. This will be done as per usual practice of conversing with the participant as treatment is performed, and will include a summary at the end of the session. The participants will be encouraged to repeat back the information to ensure they have understood it, and will also be given a flyer containing the same information. On completion of the course of manual therapy, participants will be prescribed an individualised home exercise programme in line with best practice for osteoarthritis. They will attend for an additional 45 min treatment session following either the three week or six week assessment, depending on group allocation. The physiotherapist will teach the exercise programme and check the performance of the exercises by the participant. The programme will be multi modal and include aerobic, strengthening, stretching and neuromuscular coordination exercises. Participants will be advised to perform the home exercise programme two to three times per week, and should be completed in 20-30 mins.
Following six month follow-up assessment, the home exercise programme will be checked for accuracy of performance, difficulty due to pain, or exercises becoming too easy. Participants will be asked to estimate how often per week they completed the home exercise programme. When participants have improved their strength, flexibility or general fitness, exercises will be progressed to ensure they are still tailored to produce therapeutic benefit.
Intervention code [1] 293954 0
Treatment: Other
Intervention code [2] 293955 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care for six weeks. This includes anything they choose to do to manage their condition, or any usual medication including pain relief. Following the six-week follow-up assessment, control group participants will be invited to attend for a 45 minute treatment session at the School of Physiotherapy Clinic. They will be prescribed and taught an individualised home exercise programme by a physiotherapist, in line with best practice for osteoarthritis. This will be multi modal and include aerobic, strengthening, stretching and neuromuscular coordination exercises. Participants will be advised to perform the home exercise programme two to three times per week, and should be completed in 20-30 mins. During this session the physiotherapist will deliver a standardised information package including education about osteoarthritis, and advice such as control of body weight and maintenance of regular exercise. This will be done as per usual practice of conversing with the participant as they are performing exercises, and will include a summary at the end of the session. The participants will be encouraged to repeat back the information to ensure they have understood it, and will also be given a flyer containing the same information.
Following six month follow-up assessment, the home exercise programme will be checked for accuracy of performance, difficulty due to pain, or exercises becoming too easy. Participants will be asked to estimate how often per week they completed the home exercise programme. When participants have improved their strength, flexibility or general fitness, exercises will be progressed to ensure they are still tailored to produce therapeutic benefit.
Control group
Active

Outcomes
Primary outcome [1] 297402 0
Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate pain, function, joint stiffness and quality of life
Timepoint [1] 297402 0
3 weeks or 6 weeks depending on group allocation AND 6 months
Primary outcome [2] 297403 0
Knee range of movement measured with a long-arm goniometer
Timepoint [2] 297403 0
3 weeks or 6 weeks depending on group allocation AND 6 months
Secondary outcome [1] 320968 0
Patient Global Rating of Change
Timepoint [1] 320968 0
3 weeks or 6 weeks depending on group allocation AND 6 months
Secondary outcome [2] 321674 0
Physical Performance Measure - 40 metre self-paced walk
Timepoint [2] 321674 0
3 OR 6 weeks depending on group allocation AND 6 months for all groups
Secondary outcome [3] 321675 0
Physical Performance Measure - Stair Climb Test
Timepoint [3] 321675 0
3 OR 6 weeks depending on group allocation AND 6 months for all groups
Secondary outcome [4] 321676 0
Physical Performance Measure - 30 second sit to stand
Timepoint [4] 321676 0
3 OR 6 weeks depending on group allocation AND 6 months for all groups
Secondary outcome [5] 321677 0
Feasibility measure:physiotherapist compliance with study protocols. Review of treatment chart
Timepoint [5] 321677 0
3 OR 6 weeks depending on group allocation AND 6 months for all groups
Secondary outcome [6] 321678 0
Feasibility measure: Physiotherapist satisfaction with study protocols. By interview.
Timepoint [6] 321678 0
6 months
Secondary outcome [7] 321679 0
Feasibility measure: Participant compliance with study protocol, specifically frequency of treatment sessions maintained according to group allocation. Review of attendance record.
Timepoint [7] 321679 0
6 months
Secondary outcome [8] 321680 0
Feasibility measure: Participant satisfaction with study protocols. Inclusion of question in 6-month follow-up session.
"How satisfied were you with the study protocols?" Response in 5 point likert scale:Very dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, very satisfied.
Plus space for additional comments.
Timepoint [8] 321680 0
6 months
Secondary outcome [9] 321681 0
Feasibility measure: success of recruitment. 30 participants recruited in 4 months.
Timepoint [9] 321681 0
4 months
Secondary outcome [10] 321682 0
Feasibility measure: success of retention. 90% of participants retained at 6 months
Timepoint [10] 321682 0
6 months
Secondary outcome [11] 321683 0
Feasibility measure: recording and management of adverse events.
All adverse events reported in timely manner to trial monitoring team (PI and AIs) < 24hrs, and successful management implemented, including referral to medical practitioner if necessary.
Adverse events include exacerbation of knee pain or swelling that does not subside in 48 hrs.
Timepoint [11] 321683 0
Will be monitored on an ongoing basis with review at 6 months

Eligibility
Key inclusion criteria
Adults (greater than 18yrs) with persistent knee pain meeting the clinical classification criteria for knee osteoarthritis (ACR) . In addition the nominated knee must lack full extension (at least 5 degrees loss of extension).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous lower limb joint arthroplasty, lower limb injury/surgery/knee osteoarthritis (OA) treatment in previous 12 months, consultation with orthopaedic specialist for knee OA, or commencement of new medication for OA (previous 1 month); other forms of arthritis, plus comorbidities that will preclude safe application of manual therapy.

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)
Randomisation will be conducted by a research administrator in the research centre who is not otherwise involved in the trial. It will be done using randomly generated identification numbers and allocation using opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (randomisation.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This is a three arm study with one control group and two intervention groups receiving the same treatment but at different treatment frequency. This is equivalent to a study of medication dose.
It is a feasiblity study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For the feasibility study the main emphasis will be on gathering information to inform sample size calculation for a subsequent fully powered RCT. Thus identification of variance, consideration of the minimal clinically important difference (MCID) of outcome measures, and the attrition rate of participants are all important factors. Repeated measures ANOVA analysis will be performed to detect changes in primary outcome over the multiple time-points. Descriptive stats will be used to present baseline characteristics, investigate comparability of groups. report secondary outcome measures and feasibility data. Data from individual interviews with physiotherapists about satisfaction with trial protocols will be transcribed and analysed for common themes using a general inductive approach. As this is a feasibility study, and hence does not have statistical power to detect between-group differences, little emphasis will be placed on whether a significant difference is detected between the groups. The sample size is considered adequate for a pilot/feasibility study.

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 outside Australia
Country [1] 7602 0
New Zealand
State/province [1] 7602 0
Otago

Funding & Sponsors
Funding source category [1] 292918 0
University
Name [1] 292918 0
University of Otago
Address [1] 292918 0
Clocktower Building
362 Leith St
Dunedin, 9016

PO Box 56
Dunedin 9054
Country [1] 292918 0
New Zealand
Funding source category [2] 295303 0
Charities/Societies/Foundations
Name [2] 295303 0
New Zealand Manipulative Physiotherapy Association
Address [2] 295303 0
PO Box 35-602
Browns Bay
Auckland 0753
Country [2] 295303 0
New Zealand
Primary sponsor type
Individual
Name
Dr Cathy Chapple
Address
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291675 0
None
Name [1] 291675 0
Address [1] 291675 0
Country [1] 291675 0
Other collaborator category [1] 278840 0
Individual
Name [1] 278840 0
Dr Steve Tumilty
Address [1] 278840 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country [1] 278840 0
New Zealand
Other collaborator category [2] 278841 0
Individual
Name [2] 278841 0
Associate Professor J. Haxby Abbott
Address [2] 278841 0
Orthopaedic Division, Department of Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country [2] 278841 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294424 0
Health and Disability Ethics Committees
Ethics committee address [1] 294424 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 294424 0
New Zealand
Date submitted for ethics approval [1] 294424 0
14/06/2016
Approval date [1] 294424 0
29/06/2016
Ethics approval number [1] 294424 0
16/NTA/87

Summary
Brief summary
This study will investigate the frequency of manual therapy treatment for people with knee osteoarthritis (OA). The hypothesis is that frequency of treatment will influence patient outcomes.
It is a feasibility study with a small number of participants that will not be able to determine if frequency does influence outcome, but will evaluate whether there is justification for conducting a similar large scale randomised controlled trial. It will evaluate study procedures, and acceptability as well as provide data to calculate how big a future trial may need to be.
This will be a three-arm intervention study with two intervention groups and one control group. Ten participants will be randomly assigned to each group.
Group A: standardized intervention, manual therapy to the knee, one 45 minute session per week for six weeks, at a targeted treatment interval of seven days. (Six treatments). Two further treatment sessions of 45 minutes each, to teach an individualised home exercise programme, and to progress the programme. These will take place after the follow-up assessments at six weeks and six months.
Group B: standardized intervention, manual therapy to the knee, two 45 minute sessions per week for three weeks (six treatments). Target treatment interval will be three or four days. Two further treatment sessions of 45 minutes each, to teach an individualised home exercise programme, and to progress the programme. These will take place after the follow-up assessments at three weeks and six months.
Group C (control): Two treatment sessions of 45 minutes each, to teach an individualised home exercise programme, and to progress the programme. These will take place after the follow-up assessments at six weeks and six months. Standardized intervention (minus manual therapy) will also be delivered in these two sessions.
Standardised intervention will include education about OA and general recommended advice regards self-management, such as control of body weight, and maintenance of regular exercise.
Manual therapy includes physiotherapist-generated techniques to mobilise the knee joint and stretch soft tissues. These techniques are commonly used in routine physiotherapy practice.
Outcome will be measured at three weeks, six weeks, and six months to evaluate symptoms such as pain, stiffness and function, knee movement, physical performance, and feasibility of study design and processes.
Trial website
http://www.otago.ac.nz/physio/research/ageing/otago597806.html
or
otago.ac.nz/osteoarthritisknee
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63646 0
Dr Cathy Chapple
Address 63646 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 63646 0
New Zealand
Phone 63646 0
+64 3 4795428
Fax 63646 0
Email 63646 0
cathy.chapple@otago.ac.nz
Contact person for public queries
Name 63647 0
Dr Cathy Chapple
Address 63647 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 63647 0
New Zealand
Phone 63647 0
+64 3 4795428
Fax 63647 0
Email 63647 0
cathy.chapple@otago.ac.nz
Contact person for scientific queries
Name 63648 0
Dr Cathy Chapple
Address 63648 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 63648 0
New Zealand
Phone 63648 0
+64 3 4795428
Fax 63648 0
Email 63648 0
cathy.chapple@otago.ac.nz

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