None listed
Conditions
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.
Interventions
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 identi
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.
Sponsors
The Australian Hand Surgery Society
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 yrs or older Proficiency in English Capacity to comprehend the survey Capacity to attend follow up
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
Outcome results
None listed