RecruitingACTRN12622000796785

The Conceal Trial - Targeted Muscle Re-innervation (TMR) in the treatment of chronic neuropathic and phantom limb pain following a major lower limb amputation; a functional brain MRI study

Sponsor

Monash Health

Enrollment

80 participants

Start Date

May 23, 2023

Study Type

Interventional

Conditions

Phantom limb pain Lower limb amputation Targeted Muscle Re-innervation

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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 Criteria4

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

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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 inner

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.