Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000426684
Ethics application status
Approved
Date submitted
7/04/2014
Date registered
17/04/2014
Date last updated
31/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomized clinical trial of physiotherapy intervention in early hip osteoarthritis
Scientific title
Is a physiotherapy intervention feasible for people with early hip osteoarthritis?
Secondary ID [1] 284033 0
None
Universal Trial Number (UTN)
Trial acronym
HIPO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early hip osteoarthritis 291085 0
Condition category
Condition code
Musculoskeletal 291429 291429 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 291988 291988 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions
Each participant will be treated by experienced physiotherapists who will be trained and proficient in both interventions (physiotherapy; education).

Physiotherapy
The physiotherapy intervention will be delivered in 8 sessions each of 30 minutes duration over 3-months (1/week for 4 weeks, 1/fortnight for 8 weeks). This consists of (i) manual hip joint and soft tissue mobilisation and stretching; (ii) hip muscle retraining; (iii) trunk muscle retraining; (iv) functional, proprioceptive and sports- or activity- specific retraining; (v) enhancing physical activity; and (vi) education. Education will consist of topics including exercise, weight loss if appropriate, and appropriate stretching. This will be provided during thwe physiotherapy session. Based on our pilot data, the treatment will be tailored according to each patient’s clinical presentation (e.g. strength, pain severity, sporting and functional needs), presence of co-morbidities (e.g. back and other lower-limb pain or pathology) and progressed based on response to exercise load, thus maximising the training effects. The physiotherapist will supervise exercises during each visit for 15 minutes. A home exercise program will be performed independently at home 4 times per week for 60 minutes per session. An exercise manual will be produced and made accessible to each participant. Participants will complete a self report diary which will be checked at each visit and include adherence to home exercise program, use of medications and additional activity undertaken.
Intervention code [1] 288724 0
Rehabilitation
Comparator / control treatment
Education
In order to control for the psychosocial contact inherent with the physiotherapy treatment, the education group will encompass individualised health education sessions covering topics such as exercise, diet, weight loss and appropriate stretching, in a similar fashion to previously published clinical trials looking at physiotherapy management in older people with advanced hip OA. The information sheets will be modified to be appropriate for this younger age group. The control sessions will be provided with the same frequency and duration as the physiotherapy sessions.
Control group
Active

Outcomes
Primary outcome [1] 291414 0
Primary outcome measure: Feasibility of full-scale RCT
Feasibility will be assessed by evaluating willingness of participants to enrol; number of eligible participants; recruitment rate; compliance with intervention, home exercises and log-book completion; and drop-out rate.
Timepoint [1] 291414 0
Treatment conclusion at 3 months post treatment commencement.
Secondary outcome [1] 306718 0
Hip dysfunction and Osteoarthritis Outcome Score (HOOS)-pain subscale.
This is a hip-specific patient reported outcome measure of pain.
Timepoint [1] 306718 0
Baseline and 3 months from commencement of intervention
Secondary outcome [2] 307736 0
Perceived global change score
This is a likert measure of patient reported perceived change between baseline and follow-up assessments.
Timepoint [2] 307736 0
Baseline and 3 months from commencement of intervention
Secondary outcome [3] 307737 0
International Hip Outcome Tool
This is a hip specific patient reported outcome measure which measures symptoms, job related activity, sporting activity and social activity.
Timepoint [3] 307737 0
Baseline and 3 months from commencement of intervention
Secondary outcome [4] 307738 0
HOOS-QoL subscale
This is a hip-specific patient reported outcome measure of quality of life.
Timepoint [4] 307738 0
Baseline and 3 months from commencement of intervention
Secondary outcome [5] 307739 0
Tampa Scale for Kinesiophobia.
Timepoint [5] 307739 0
Baseline and 3 months from commencement of intervention
Secondary outcome [6] 307740 0
Hip muscle strength and hip flexion and internal rotation range. This will be measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer. Hip flexion and internal range of motion will be an active measure measured with an inclinometer.
Timepoint [6] 307740 0
Baseline and 3 months from commencement of intervention
Secondary outcome [7] 307874 0
AQoL-4D. This is a generic questionnaire based measure of patient-reported quality of life.
Timepoint [7] 307874 0
Baseline and 3 months from commencement of intervention.

Eligibility
Key inclusion criteria
Inclusion Criteria:
(i) aged 18-50 yr; (ii) arthroscopy for intra-articular hip pathology during the past 12 to 36 months; (iii) evidence of early-onset hip OA (defined as chondropathy greater than or equal to Outerbridge grade 1) at time of hip arthroscopy; (iv) hip-related pain > 30 on a 100mm Visual Analogue Scale (VAS).
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
(i) pain that is not confirmed by physical examination of the hip; (ii) concurrent symptoms of hip bursitis or tendinitis; (iii) surgical complications including infection; (iv) planned lower limb surgery in the following 12 months (eg arthroplasty); (v) physical inability to weight-bear fully or undertake testing procedures; (vi) inability to understand 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)
Potential participants will be identified by the surgeon, and invited to contact the Project co-ordinator. Volunteers will be screened via telephone interview, followed by a clinical examination to confirm eligibility. The randomisation schedule (permuted blocks of varying sizes), generated and maintained centrally by the University of Queensland, School of Health and Rehabilitation Sciences, will be revealed via telephone following baseline assessment. The blinded researcher will perform outcome assessments at baseline and 3 months, and participants will be instructed not to divulge their group allocation to the assessor. The research group will access patient’s past medical and surgical records to obtain details of surgical intervention and pre-operative radiological findings.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule (permuted blocks of varying sizes), will be generated and maintained centrally by the University of Queensland, School of Health and Rehabilitation Sciences
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Statistical methods / analysis
The primary outcomes measured at 3 months will include recruitment rate, compliance with all aspects of intervention and drop-out rate. Secondary outcomes will be analysed using linear mixed regression models, including their respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Participant characteristics (e.g.; gender, age) will be included as covariates. We aim to detect the minimum clinically important improvement on this outcome as reported by Kemp et al.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2014
Actual
5/05/2014
Date of last participant enrolment
Anticipated
29/08/2014
Actual
30/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 7741 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 288664 0
Charities/Societies/Foundations
Name [1] 288664 0
Physiotherapy Research Foundation
Country [1] 288664 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Health and Rehabiliation Sciences
St Lucia
QLD 4067
Country
Australia
Secondary sponsor category [1] 287372 0
Commercial sector/Industry
Name [1] 287372 0
Bodysystem PL
Address [1] 287372 0
38 Collins St
Hobart TAS 7000
Country [1] 287372 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290514 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 290514 0
University of Queensland
St Lucia
Queensland 4067
Ethics committee country [1] 290514 0
Australia
Date submitted for ethics approval [1] 290514 0
Approval date [1] 290514 0
05/02/2014
Ethics approval number [1] 290514 0
20130001553

Summary
Brief summary
Hip osteoarthritis (OA) is associated with significant personal and societal burden, which is rising with increased life expectancy. Early hip OA is commonly seen during hip arthroscopic surgery, and can affect younger adults (age<55 years) with peak work and family commitments. Whilst hip arthroscopy is commonly undertaken for pain associated with early hip OA, no studies have examined best practice for post-operative rehabilitation. An effective intervention for early-onset hip OA will potentially have great personal and societal impact. The primary aim of this study is to establish the feasibility of a randomised clinical trial (RCT) of physiotherapy, targeted to improve hip joint range and hip-related symptoms in early-onset hip OA. This study is a blinded pilot RCT conforming to CONSORT guidelines. Twenty people with early hip OA who had hip arthroscopy surgery six to 12 months previously will be recruited and randomized to the intervention group (individualized manual therapy, exercise therapy and education) or the control group (education only). Eight interventions will occur for both groups over three months, with outcomes collected at baseline and three months. Primary outcome measure - feasibility of a full scale RCT. Secondary outcome measures - symptoms, quality-of-life and range-of-motion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46034 0
A/Prof Kay Crossley
Address 46034 0
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia
QLD 4067
Country 46034 0
Australia
Phone 46034 0
+61733653008
Fax 46034 0
Email 46034 0
k.crossley@uq.edu.au
Contact person for public queries
Name 46035 0
Ms Joanne Kemp
Address 46035 0
Bodysystem
38 Collins St
Hobart TAS 7000
Country 46035 0
Australia
Phone 46035 0
+61362315991
Fax 46035 0
Email 46035 0
joannekemp@bodysystem.com.au
Contact person for scientific queries
Name 46036 0
A/Prof Kay Crossley
Address 46036 0
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia
QLD 4067
Country 46036 0
Australia
Phone 46036 0
+61733653008
Fax 46036 0
Email 46036 0
k.crossley@uq.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
EmbaseA pilot randomised clinical trial of physiotherapy (manual therapy, exercise, and education) for early-onset hip osteoarthritis post-hip arthroscopy.2018https://dx.doi.org/10.1186/s40814-017-0157-4
N.B. These documents automatically identified may not have been verified by the study sponsor.