Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000605594
Ethics application status
Approved
Date submitted
20/05/2015
Date registered
9/06/2015
Date last updated
25/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of using silicone oil for hand exercises as a home based rehabilitation program following Dupuytrens contracture release surgery.
Scientific title
Dupuytrens contracture release patients post operatively using silicone oil for home hand rehabilitation exercises compared to standard hand exercises using primary outcomes of SEGUE scores, pain scores, and patient acceptability with CSQ8S as an RCT feasibility study.
Secondary ID [1] 286736 0
None
Universal Trial Number (UTN)
U1111-1170-1432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dupuytrens Disease affecting the fingers 295098 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295344 295344 0 0
Physiotherapy
Musculoskeletal 295454 295454 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A small container of medical grade silicone oil (dimethyl silicone fluid) with a viscosity of 350 centistokes is used to immerse the operated hand into for 20 minutes while a series of finger exercises are completed. The intervention commences on day 3 after finger contracture release surgery and terminates at 14 days post surgery when wound healing is achieved. The exercises are taught at the first visit in a single 45 minute session with the physiotherapist. The patient is instructed to make a full fist as able, hold, then slowly straighten the fingers. Repeat this slowly for 10 repetitions, then rest for 2 minutes. Repeat the above routine 4 times, during the total immersion period of 20 minutes once daily. The patient will have the container of oil at home with them.
The patient will complete a treatment diary to monitor the intervention.
Intervention code [1] 291891 0
Rehabilitation
Intervention code [2] 291906 0
Treatment: Other
Comparator / control treatment
The active control group will perform the same protocol of exercises for 20 minutes per day, from day 3-14 post-operatively at home without using an immersion medium.
This treatment constitutes usual care.
Control group
Active

Outcomes
Primary outcome [1] 295095 0
Physiotherapy delivery of intervention assessed using a SEGUE score.
Timepoint [1] 295095 0
Timepoint:Day 3 post surgery.
Primary outcome [2] 295096 0
Patient receipt and enactment of intervention assessed by
number of finger flexions completed within the 20 minute exercise period. This composite outcome involves (a) an independent researcher making one video recording of each participant completing their exercises at home and (b) a daily self recorded treatment diary by the patient.
Timepoint [2] 295096 0
Daily diary from day 3 to day 14 post-operatively with one video recording occurring between days 3-14.
Primary outcome [3] 295097 0
Patient acceptability of the intervention assessed using CSQ8 survey and focus group discussion.
Timepoint [3] 295097 0
3 months after surgery
Secondary outcome [1] 314762 0
Health related quality of life questionnaire, The Michigan Hand Outcome Questionnaire (MHOQ) and URAM.
Timepoint [1] 314762 0
Baseline ie pre-operatively and final outcome 3 months after surgery.
Secondary outcome [2] 314763 0
Range of motion and measurement of fixed flexion deformities in the affected fingers will be done using goniometry.
Timepoint [2] 314763 0
Measured on four occasions:
baseline (1 week pre-operatively) with repeated measures taken at three and fourteen days post-operatively, and the final outcome at twelve weeks after surgery.
Secondary outcome [3] 315115 0
Level of pain while completing 20 minutes of finger exercises assessedusing numerical pain rating scale (NPRS).
Timepoint [3] 315115 0
Daily from days 3 -14.
Secondary outcome [4] 315116 0
Level of difficulty completing intervention assessed using a Likert scale
where 0 = Easy, 5= someone helped me a little, 10= needed another person to change my wound dressings.
Timepoint [4] 315116 0
Daily from day 3-14 post operatively.

Eligibility
Key inclusion criteria
Those individuals who are scheduled to:
1. Undergo surgical release of DD with or without associated proximal inter-phalangeal (PIP) joint contracture and, with no prior history of a DD intervention.
2. An ability to understand English and complete the required forms associated with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those individuals with:
1. Pre-existing finger injuries or conditions that affect range of motion, such as carpal tunnel syndrome, rheumatoid arthritis or other medical conditions that could confound the health related quality of life assessment.
2. Previous hand surgery, needling or injections for DD.
3. DD surgery requiring skin grafts.

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)
Participants will provided with a written information sheet and have an opportunity to ask questions at a pre-operative appointment. Written informed consent documents will be completed at this point to enroll a participant into the study. The assessment will be conducted at the physiotherapy clinic in the week prior to the patients scheduled surgery.The physiotherapy practice receptionist will allocate participants to either Group I or Group II when they phone to book their first appointment. Allocation to the two groups - Group I (usual care-without SO) or Group II ( usual care with SO) will be carried out by the receptionist whereby the sequentially numbered sealed envelopes will determine which arm of the study the participant enters into.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequentially numbered sealed envelopes will be used that contain the allocation sequence generated from the website Randomisation.com.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
An RCT to investigate feasibility, treatment fidelity and patient satisfaction when SO is randomly assigned into a post-operative home based hand exercise program.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Base line demographics and characteristics of participants will be analyzed with descriptive statistics. The mean SEGUE scores will be compared between study Group I and Group II to evaluate the degree of uniformity in delivery of both interventions using independent t-tests.
How receptive the patient is to the intervention will be assessed using the numerical rating scale for pain, and the Likert scale for level of difficulty. A comparison between the intervention groups I and II will be made using independent t-tests to identify if the SO intervention was thought to be significantly more difficult, or painful, from the patient perspective. Enactment will be measured by comparing patient diaries with the protocol for daily exercises and number of minutes spent in oil for variances from the protocol. The number of finger flexion and extensions will be counts from video footage compared to the number specified in the protocol and will be analyzed using a t-test.
Acceptability of Intervention from the patient perspective will be determined by the satisfaction survey CSQ-8. Independent t tests between the 2 study groups will be performed to identify if a significant difference exists. Free text from the open ended questions will be analyzed by grouping the data into clusters and themes then classified by frequencies. Qualitative data collected from the focus group will be analyzed using the same method. Quality of life questionnaires (MHOQ and URAM) will be analyzed using t tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/06/2015
Actual
18/02/2016
Date of last participant enrolment
Anticipated
18/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6887 0
New Zealand
State/province [1] 6887 0
Wellington

Funding & Sponsors
Funding source category [1] 291288 0
Charities/Societies/Foundations
Name [1] 291288 0
Proposed funding from:
New Zealand Association of Hand Therapist Research Fund.
Physiotherapy New Zealand, Wellington Branch.
Country [1] 291288 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
School of Phyiotherapy
PO Box 56
Dunendin 9054
Country
New Zealand
Secondary sponsor category [1] 289971 0
None
Name [1] 289971 0
Address [1] 289971 0
Country [1] 289971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292855 0
Heath and Disabilities Ethics Committes
Ethics committee address [1] 292855 0
Ethics committee country [1] 292855 0
New Zealand
Date submitted for ethics approval [1] 292855 0
19/05/2015
Approval date [1] 292855 0
17/07/2015
Ethics approval number [1] 292855 0
15/CEN/69

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 459 459 0 0
/AnzctrAttachments/368572-Study Outline for Silicone Oil Intervention GD.docx
Attachments [2] 460 460 0 0
/AnzctrAttachments/368572-Appendix 1 Maori Ethics Consultation.pdf

Contacts
Principal investigator
Name 57346 0
Ms Gail Donaldson
Address 57346 0
Wellhand
28 Waterloo Quay
Wellington 6011
Country 57346 0
New Zealand
Phone 57346 0
+64 4 4711012
Fax 57346 0
+64 4 4711013
Email 57346 0
[email protected]
Contact person for public queries
Name 57347 0
Gail Donaldson
Address 57347 0
Wellhand
28 Waterloo Quay
Wellington 6011
Country 57347 0
New Zealand
Phone 57347 0
+64 4 4711012
Fax 57347 0
+64 4 4711013
Email 57347 0
[email protected]
Contact person for scientific queries
Name 57348 0
Meredith Perry
Address 57348 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 57348 0
New Zealand
Phone 57348 0
+64 3 4795424
Fax 57348 0
+64 3 4798414
Email 57348 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
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