None listed
Conditions
Brief summary
The aim of the conceal trial is to determine the mechanism underlying phantom limb pain in lower limb amputees using targeted muscle re-innervation and functional brain MRI. Patients will be randomised to TMR or medical management groups in a 2:1 ratio and undergo functional brain MRI pre-operatively and 12 months post-operatively (12 months apart if they are randomised to the medical management group). They will also complete pain and function questionnaires NRS, PROMIS, Neuro-QOL pre-operatively and 1, 3, 6, 9 and 12 months post-operatively.
Interventions
Targeted Muscle re-innervation (TMR):
In this technique, the neuroma is excised and the distal end of the newly freshened nerve in the amputated stump is coapted to nearby motor nerves that now innervate redundant muscle
The operating team will be plastic surgeons trained in performing TMR surgery.
The operation is expected to take approximately 1.5 - 2 hours.
Operative technique as well as use of torniquet, paralytic agents, nerve blocks and drains will be at the discretion of the operating
Targeted Muscle re-innervation (TMR): In this technique, the neuroma is excised and the distal end of the newly freshened nerve in the amputated stump is coapted to nearby motor nerves that now innervate redundant muscle The operating team will be plastic surgeons trained in performing TMR surgery. The operation is expected to take approximately 1.5 - 2 hours. Operative technique as well as use of torniquet, paralytic agents, nerve blocks and drains will be at the discretion of the operating team. These changes were made at the start of the trial once patient recruitment had started but before randomisation of patients.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have undergone a major lower limb amputation in the last 5 years and currently diagnosed with chronic neuropathic and phantom limb pain, but who have not undergone previous surgical intervention to treat their neuropathic and phantom limb pain
Exclusion criteria
Patients who are double amputees Patients who have already undergone TMR Patients unable to proceed with a functional brain MRI for any reason Patients with cognitive impairment
Outcome results
None listed