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Trial registered on ANZCTR


Registration number
ACTRN12622000796785
Ethics application status
Approved
Date submitted
17/04/2022
Date registered
7/06/2022
Date last updated
25/07/2024
Date data sharing statement initially provided
7/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 306953 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Chronic neuropathic pain 326066 0
Phantom limb pain 326067 0
Lower limb amputation 326068 0
Targeted Muscle Re-innervation 326069 0
Condition category
Condition code
Surgery 323377 323377 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323399 0
Treatment: Surgery
Comparator / control treatment
The control group will also undergo medical management, which is essentially non-surgical or non-interventional. They are permitted to continue conservative measures, such as rehabilitation or analgesia.
This change was instigated once recruitment had started but before randomisation of patients into their groups.
Control group
Active

Outcomes
Primary outcome [1] 331113 0
Pain - this will be assessed via the Numerical rating scale
Timepoint [1] 331113 0
Pre-operatively

Post-operatively at 1, 3, 6, 12 months
Primary outcome [2] 331516 0
PROMIS pain scale
Timepoint [2] 331516 0
Pre-opertaively

Post-operatively at 1, 3, 6, 12 months
Primary outcome [3] 331517 0
Neuro-QOL - lower extremity function
Timepoint [3] 331517 0
Pre-operatively

Post-operatively at 1, 3, 6, 12 months
Secondary outcome [1] 408797 0
Functional brain MRI
Timepoint [1] 408797 0
TMR group: Pre-operatively and post- operatively at 12 months
Medical management group: patients will undergo two fMRI 12 months apart
Secondary outcome [2] 410145 0
Structural brain MRI
Timepoint [2] 410145 0
TMR group: Pre-operatively and post- operatively at 12 months
Medical management group: patients will undergo two fMRI 12 months apart

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
Patients will be recruited into the study by the Clinical Principle Investigator. At the time of recruitment, the Clinical Principle Investigator will be unaware to which group (control or treatment) the subject will be allocated to. Allocation will be determined at a later date in theatre, immediately following anaesthetic induction.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size and randomisation:
Change in NRS worst pain score from baseline to 12 months post-surgery is the primary end point. A difference of 2 points in NRS change is considered clinically significant (Dumanian et al 2019). Assuming a standard deviation of 3 points, 80 patients (53 treatment and 27 control) will be needed to show an average difference of 2 points in NRS change between treatment groups with 80% power at the 5% level of significance using a 2:1 allocation ratio such that 2/3 of participants will be randomly allocated to the treatment group and 1/3 of participants will be allocated to the control group.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
23/05/2023
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
80
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26863 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 42924 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 311271 0
University
Name [1] 311271 0
Monash University
Country [1] 311271 0
Australia
Funding source category [2] 317053 0
Hospital
Name [2] 317053 0
Department of Vascular Surgery, Monash Health
Country [2] 317053 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road, Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 312630 0
None
Name [1] 312630 0
Address [1] 312630 0
Country [1] 312630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310779 0
Monash Health
Ethics committee address [1] 310779 0
Ethics committee country [1] 310779 0
Australia
Date submitted for ethics approval [1] 310779 0
29/05/2022
Approval date [1] 310779 0
16/08/2022
Ethics approval number [1] 310779 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118834 0
Dr Mitra Rahmatzadeh
Address 118834 0
Department of Vascular Surgery
Monash Health
246 Clayton Road, Clayton, Victoria 3168
Country 118834 0
Australia
Phone 118834 0
+61 405141456
Fax 118834 0
Email 118834 0
[email protected]
Contact person for public queries
Name 118835 0
Mitra Rahmatzadeh
Address 118835 0
Department of Vascular Surgery
Monash Health
246 Clayton Road, Clayton, Victoria 3168
Country 118835 0
Australia
Phone 118835 0
+61 405141456
Fax 118835 0
Email 118835 0
[email protected]
Contact person for scientific queries
Name 118836 0
Mitra Rahmatzadeh
Address 118836 0
Department of Vascular Surgery
Monash Health
246 Clayton Road, Clayton, Victoria 3168
Country 118836 0
Australia
Phone 118836 0
+61 405141456
Fax 118836 0
Email 118836 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
Intellectual property ownership


What supporting documents are/will be available?

No Supporting Document Provided



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.