Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001757202
Ethics application status
Approved
Date submitted
17/10/2018
Date registered
25/10/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
5/11/2019
Date results information initially provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
In-person vs written patient information post carpal tunnel surgery
Scientific title
Single hand therapist consultation vs written patient information following carpal tunnel surgery: A pilot study
Secondary ID [1] 296353 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 310080 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308829 308829 0 0
Occupational therapy
Musculoskeletal 308914 308914 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After undergoing Carpal Tunnel release surgery all patients at the participating hospital currently receive a written leaflet developed by the hand therapy team. This is given to the patient at their first post-operative appointment with the nurse and surgeon, 10-14 days post-surgery. The leaflet describes the surgical procedure in plain language and includes a diagram of the anatomical structures. It provides information regarding wound care, timing of stitch removal, management of swelling, recommended hand exercises, and activity precautions.

Those randomised to the intervention group will also receive one face-to-face 30 minute hand therapy appointment on the same day (i.e. after their first post-operative appointment with the nurse and surgeon). In this appointment, the occupational therapy student researcher (under supervision of a senior hand therapist) will reiterate the information in the leaflet, ask about symptoms, check the recovery of the wound, demonstrate exercises and scar management and answer questions.
Intervention code [1] 312686 0
Rehabilitation
Comparator / control treatment
Control group will receive usual treatment (written leaflet only)

Comparator group will receive usual treatment (written leaflet) plus one face-to-face hand therapy appointment
Control group
Active

Outcomes
Primary outcome [1] 307803 0
1. For feasibility measures, we will report on:
a. Rates of recruitment and retention over the proposed 12 week follow-up; and
b. Whether participants understand and fully complete study questionnaires and data collection tools (e.g. do they provide no answer, multiple answers, qualified answers, or unanticipated answers to study questions?)
Timepoint [1] 307803 0
12 weeks post surgery
Secondary outcome [1] 352965 0
Boston Carpal Tunnel Questionnaire (BCTQ) - measures symptoms and function
Timepoint [1] 352965 0
6 and 12 weeks post surgery
Secondary outcome [2] 352966 0
Health related Quality of Life (as measured by EuroQol questionnaire (EQ-5D-5L and visual analogue scale)
Timepoint [2] 352966 0
6 and 12 weeks post surgery
Secondary outcome [3] 352967 0
days missed from work (related to this surgery) will be collected by participant report
Timepoint [3] 352967 0
6 and 12 weeks post surgery
Secondary outcome [4] 352968 0
health resource utilisation (appointments with GP, or other health professional relating to this surgery) will be collected using a Health Resource Utilisation Questionnaire designed by the researchers.
Timepoint [4] 352968 0
6 and 12 weeks post surgery
Secondary outcome [5] 352969 0
Satisfaction with outcome. Participants will be asked to rate their response to three questions using a 5-point scale

Q1: I am satisfied with the level of information and care I received after surgery.
Q2: I found the information leaflet useful for my recovery.
Q3: I am satisfied with the outcome of my surgery.
Timepoint [5] 352969 0
12 weeks post surgery

Eligibility
Key inclusion criteria
Adults who undergo elective Open Carpal Tunnel Release (OCTR) surgery at Frankston Hospital, Peninsula Health between November 2018 and April 2019.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with additional upper limb diagnoses requiring treatment or surgery
Those who have had additional surgery at the time of OCTR
Those who are unable to read and understand outcome measures due to limited functional English ability or known cognitive impairments

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer - this will be created by an independent blinded researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use block randomisation (in groups of eight) to allocate participants to one of two groups. Allocation will be determined using a computer generated random number sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Preliminary data for participant outcome measures collected pre-operatively and then at three post-operative appointment time points will be compared between groups using t tests for normally distributed data and Wilcoxon rank-sum tests for skewed data.

A cost-benefit comparison will include utility scores calculated from EQ-5D-5L and we will also compare health resource utilisation and days off work.

For all analyses, a two-sided p value < 0.05 was considered significant.

Data will be analysed by the student researcher (under supervision of supervisors blinded to group allocation) using Statistical package for the Social Sciences (SPSS) v 25.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2018
Actual
16/02/2019
Date of last participant enrolment
Anticipated
8/04/2019
Actual
24/03/2019
Date of last data collection
Anticipated
1/07/2019
Actual
1/07/2019
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12192 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 24364 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 300957 0
University
Name [1] 300957 0
Monash University
Country [1] 300957 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Occupational Therapy
Monash University,
McMahon's Road
Frankston 3199
Victoria
Country
Australia
Secondary sponsor category [1] 300536 0
None
Name [1] 300536 0
Address [1] 300536 0
Country [1] 300536 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301722 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 301722 0
Office for Research
Peninsula Health
PO Box 52
Frankston VIC 3199
Ethics committee country [1] 301722 0
Australia
Date submitted for ethics approval [1] 301722 0
09/10/2018
Approval date [1] 301722 0
13/12/2018
Ethics approval number [1] 301722 0

Summary
Brief summary
After undergoing Carpal Tunnel release surgery, Peninsula Health patients currently are provided with a written leaflet developed by the hand therapy team at their first post-operative appointment. This is usually 10-14 days post-surgery. It is possible that patients may recover faster if they also receive a face-to-face consultation with a hand therapist, however there is only low level evidence from a retrospective case series study (Mack et al., 2017) to support this.

We propose to complete a pilot study to see whether a randomised control trial would be feasible at Peninsula Health. The pilot study will take place over a 3 month data collection period, which is predicated on research honours student availability. Based on 2017 data, it is anticipated that the study could recruit a minimum of 20 patients (note: the original target of 50 was revised due to a downturn in the number of surgeries performed at this site, and a reduced recruitment period due to changed student project parameters).

In this pilot study, participants will be randomised to two groups:

1: control group who will receive usual treatment (written information provision)
2: treatment group who will receive usual treatment plus one face-to-face hand therapy appointment

We aim to collect data pre-operatively and then on three occasions over a 12 week timeframe: initial post-operative phase (10-14 days after surgery), 6 weeks and 12 weeks. Patient-rated outcome measures will include the Boston Carpal Tunnel Questionnaire; Quality of Life (using the EQ-5D-5L) and patient satisfaction with their recovery. We will also report on any complications such as Pillar Pain, infection and wound breakdown. Participants will be offered the choice of paper, on-line or phone-based completion of these measures.

We will also conduct a basic cost-benefit analysis using utility scores calculated from the EQ-5D-5L and information regarding time off work and other health resource usage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87886 0
A/Prof Lisa O'Brien
Address 87886 0
Department of Occupational Therapy
Monash University
Peninsula Campus
McMahon's Rd
Frankston 3199
Victoria
Country 87886 0
Australia
Phone 87886 0
+61 399044100
Fax 87886 0
Email 87886 0
[email protected]
Contact person for public queries
Name 87887 0
A/Prof Lisa O'Brien
Address 87887 0
Department of Occupational Therapy
Monash University
Peninsula Campus
McMahon's Rd
Frankston 3199
Victoria
Country 87887 0
Australia
Phone 87887 0
0399044100
Fax 87887 0
Email 87887 0
[email protected]
Contact person for scientific queries
Name 87888 0
A/Prof Lisa O'Brien
Address 87888 0
Department of Occupational Therapy
Monash University
Peninsula Campus
McMahon's Rd
Frankston 3199
Victoria
Country 87888 0
Australia
Phone 87888 0
0399044100
Fax 87888 0
Email 87888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
pilot project only


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 376207-(Uploaded-23-10-2019-09-45-59)-Basic results summary.docx
Plain language summaryNo Results We recruited 17 participants during our t... [More Details]

Documents added automatically
No additional documents have been identified.