Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000140651p
Ethics application status
Submitted, not yet approved
Date submitted
13/12/2022
Date registered
9/02/2023
Date last updated
9/02/2023
Date data sharing statement initially provided
9/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Surgery Compared with Radiofrequency Ablation for Partial Wrist Denervation (SRAPiD) Trial
Scientific title
Pain outcomes after surgery compared with radiofrequency ablation for partial wrist denervation (SRAPiD) in adults with end-stage wrist osteoarthritis
Secondary ID [1] 308549 0
None
Universal Trial Number (UTN)
Trial acronym
SRAPiD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Painful end-stage wrist osteoarthritis 328463 0
Condition category
Condition code
Musculoskeletal 325496 325496 0 0
Osteoarthritis
Surgery 325497 325497 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiofrequency ablation will be used to denervate the terminal branches of the nerves in the wrist (terminal branches of the anterior interosseus nerve and posterior interosseus nerve) using a single dorsal approach. This will be performed by a single radiologist (SF), a consultant who specialises in musculoskeletal imaging and intervention. This will be performed at St Vincent’s Private Hospital on an outpatient basis without sedation. First, once the posterior interosseus nerve (PIN) is identified via ultrasound, local anaesthetic (2mL of 1% lidocaine) will be injected around the nerve for confirmation prior to ablation. A radiofrequency ablation probe will then be advanced at a 45 degree angle in a proximal to distal direction tangential to the major axis of the PIN. A 480Hz direct current will be applied, generating an ablation effect of 80°C/J, maintained for 60 seconds. Similarly, the anterior interosseus nerve (AIN) will be identified via ultrasound and confirmed via local anaesthetic. The radiofrequency probe will then be placed adjacent to the AIN and another 480Hz direct current applied, generating an ablation effect of 80°C/J, maintained for 60 seconds. This will be a once-only session lasting approximately 45 minutes. SF will be aware of which patients are assigned to this intervention and will confirm attendance.

The patient will commence guided range of motion exercises with hand therapy 1 week after the procedure (RP, SD, NA). The therapy will progress with weekly sessions (30-60mins) for 4 weeks. The therapy will be administered by certified hand therapists from either a physiotherapy or occupational therapy background. The protocol for hand therapy includes

Post Op Week 1
- removal post op dressings
- wound care and oedema control as required
- start early desensitization over dressings
- start early active range of motion exercises
- proprioceptive exercises – gentle and mid-range
- focus on education regarding importance normal movement patterns and integration of hand function during light ADLs

Post Op Week 2
- remove wound steri strips and commence scar massage
- ongoing oedema control as required (+/- intermittent use of tubigrip)
- increase desensitization program
- progress active range of motion exercises, add progressive end of range stretch and upgrade proprioceptive exercises
- ongoing focus functional use and normal movement patterns

Post Op Week 3
- discard any use of tubigrip or supports
- progress end of range stretches and proprioception exercises aiming for full range of motion
- commence light strengthening and further increase focus heavier functional use
- return to work or sports

Post Op Week 4
- upgrade strengthening program
- final review with expectation of full functional recovery
- discharge from hand therapy

Strategies to monitor patient adherence to therapy protocol include 1/ use of patient therapy diary for instructions for home program which requires patient to ‘tick the box’ when done prescribed program daily and 2/ at beginning of each session therapist to ask for demonstration of previous sessions home program.
Intervention code [1] 325042 0
Treatment: Other
Comparator / control treatment
Participants in this group will be treated with surgery to denervate the terminal branches of the nerves in the wrist (terminal branches of the anterior interosseus nerve and posterior interosseus nerve) using a single dorsal approach. This is the predominent technique currently used for patial wrist denervation. This will be performed by three consultant hand surgeons (PS, DR, RL) at St Luke's Hospital, Macquarie University Hospital and North Shore Private Hospital. Patients will receive either a regional anesthetic or local anesthesia with parenteral sedation. A pneumatic tourniquet will be applied to the upper arm. A 3-5cm longitudinal incision will be made dorsally over the interval between the distal radius and ulna. The soft tissue will be dissected and once the nerves are identified, they will be resected with bipolar cautery. The tourniquet is released and haemostasis is performed. A layered wound closure is completed and a soft, sterile dressing applied. Postoperatively, follow up will occur at 1-2 weeks for a wound check. This will be a once-only procedure lasting approximately 1 hour, The patient will commence guided range of motion exercises with hand therapy after the initial follow up appointment (RP, SD, NA). Hand therapy will be conducted in the same manner as for participants in the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 333348 0
Pain score using an 11-point numeric rating scale
Timepoint [1] 333348 0
Baseline, 3 months, 6 months and 12 months (primary timepoint) post treatment
Secondary outcome [1] 416691 0
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Timepoint [1] 416691 0
Baseline, 3 months, 6 months and 12 months post treatment
Secondary outcome [2] 416692 0
Patient satisfaction measured using the question ‘how would you describe the results of your operation’ with five options provided (‘excellent’, ‘very good’, ‘good’, ‘fair’ and ‘poor’)
Timepoint [2] 416692 0
3 months, 6 months and 12 months post treatment
Secondary outcome [3] 416693 0
Time taken to return to work using study-specific questionaire
Timepoint [3] 416693 0
Assessed at 3 months, 6 months and 12 months post treatment
Secondary outcome [4] 416694 0
Grip strength measured using a Jamar dynamometer (Lafayette Instrument Company, Lafayette, IN)
Timepoint [4] 416694 0
Baseline, 3 months, 6 months and 12 months post treatment
Secondary outcome [5] 416695 0
Range of motion (flexion) at the wrist
Timepoint [5] 416695 0
Baseline, 3 months, 6 months and 12 months post treatment
Secondary outcome [6] 416949 0
Range of motion (extension) at the wrist
Timepoint [6] 416949 0
Baseline, 3 months, 6 months and 12 months post treatment
Secondary outcome [7] 416950 0
Range of motion (pronation) at the wrist
Timepoint [7] 416950 0
Baseline, 3 months, 6 months and 12 months post treatment
Secondary outcome [8] 416951 0
Range of motion (supination) at the wrist
Timepoint [8] 416951 0
Baseline, 3 months, 6 months and 12 months post treatment

Eligibility
Key inclusion criteria
Age 18 yrs or older
Proficiency in English
Capacity to comprehend the survey
Capacity to attend follow up
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Wrist instability
Concomitant procedures (e.g. carpal tunnel release)
Patients with medical conditions that preclude anaesthesia or surgery
People with a cognitive impairment, an intellectual disability or a mental illness

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 independent person will place the allocation list in sequentially numbered, opaque, tamper-proof envelopes handled only by the independent person and the principal researcher. The researchers are blinded to the allocation sequence. As a patient is enrolled in the study, the associate researchers (hand surgeon, interventional radiologist) will contact the principal researcher, who will open the relevant envelope and reveal the randomised allocation to the associate researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation to surgery group or radiofrequency ablation group occurred according to computer-generated random numbers. The randomisation will be carried out by an independent person, who is unaware of the study protocol and not otherwise in control of the study.
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
Using SPSS Statistical Software and Microsoft Excel, descriptive statistics will be produced to analyse data obtained from the study. In this process, scores will be assigned to each question and univariate analysis will be used to examine mean values and confidence intervals for each response.

This study is a non-inferiority clinical trial, where we aim to show the intervention (radiofrequency ablation) to be non-inferior to the control (surgery). The mean clinical important difference (MCID) has been approximated as 2 for the primary outcome (pain score using VAS) based on previous literature. A power analysis was conducted using an alpha value of 5% and beta value of 80%. A standard deviation was assumed to be 2.3. A sample size of 34 patients (17 patients in each group) would be required to adequately power this trial. We aim to recruit 42 patients (21 in each group) to allow for 20% loss to follow up.

All data will be handled securely and in accordance with patient privacy. Each computer containing data will be password protected and paper records will be stored in a locked cabinet within the hand surgery department. After the data collection is completed, all identifiers will be removed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23703 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 23704 0
St Luke's Hospital - Potts Point
Recruitment hospital [3] 23705 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [4] 23706 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 39139 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 39140 0
2011 - Potts Point
Recruitment postcode(s) [3] 39142 0
2065 - St Leonards
Recruitment postcode(s) [4] 39141 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 312797 0
Charities/Societies/Foundations
Name [1] 312797 0
The Australian Hand Surgery Society
Country [1] 312797 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Australian Hand Surgery Society
Address
Level 3 Building C
St Vincent’s Hospital
41 Victoria Parade
Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 314485 0
None
Name [1] 314485 0
Address [1] 314485 0
Country [1] 314485 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312084 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 312084 0
Research Office
St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 312084 0
Australia
Date submitted for ethics approval [1] 312084 0
13/12/2022
Approval date [1] 312084 0
Ethics approval number [1] 312084 0

Summary
Brief summary
It is difficult to manage patients with end-stage wrist osteoarthritis. Though fusion of the wrist is effective in reducing pain, there are significant losses in range of motion and potential complications relating to healing or hardware. For these reasons, a more conservative approach for management of chronic wrist pain may be preferable. Partial wrist denervation, instead, is a procedure which targets the small nerves in the wrist to manage chronic pain, whilst still preserving baseline range of motion. This has traditionally been performed surgically, which involves a small incision and resecting the relevant nerves. Patients receive an anaesthetic and parenteral sedation. Recently, a technique using ultrasound and heat ablation through the skin has instead been described. This avoids the risks of surgery and can be done on an outpatient basis without sedation. The limited data thus far show similar benefits to surgery, however it is still an emerging technique without a direct comparison to surgery.

In this randomised control trial we look to compare two techniques of partial wrist denervation (surgery, radiofrequency ablation) for improvement of pain in end-stage wrist arthritis. Our hypothesis is that the intervention (radiofrequency ablation) is non inferior to the control (surgery). The primary outcome is to compare pain scores for the two groups using a visual analogue scale. The secondary outcomes include an assessment of function, motion, strength, satisfaction and return to work. We believe this study to have importance in guiding future management decisions for this complex clinical scenario.

This study is therefore designed to compare the effectiveness of partial wrist denervation through surgery or through ultrasound ablation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123414 0
Dr Abhinav Aggarwal
Address 123414 0
Sydney Hospital
8 Macquarie Street
Sydney, 2000
New South Wales
Country 123414 0
Australia
Phone 123414 0
+61 432927225
Fax 123414 0
Email 123414 0
aggarwal.abhinav@gmail.com
Contact person for public queries
Name 123415 0
Dr Abhinav Aggarwal
Address 123415 0
Sydney Hospital
8 Macquarie Street
Sydney, 2000
New South Wales
Country 123415 0
Australia
Phone 123415 0
+61 2 9382 7111
Fax 123415 0
Email 123415 0
info@handwrist.com.au
Contact person for scientific queries
Name 123416 0
Dr Abhinav Aggarwal
Address 123416 0
Sydney Hospital
8 Macquarie Street
Sydney, 2000
New South Wales
Country 123416 0
Australia
Phone 123416 0
+61 2 9382 7111
Fax 123416 0
Email 123416 0
info@handwrist.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not worked in a plan for data sharing at this point.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.