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Trial registered on ANZCTR


Registration number
ACTRN12617000650392p
Ethics application status
Not yet submitted
Date submitted
10/04/2017
Date registered
5/05/2017
Date last updated
5/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Electric Nerve Stimulation to Enhance Functional Outcomes After Peripheral Nerve Injury Repair
Scientific title
Electric Nerve Stimulation to Enhance Functional Outcomes After Peripheral Nerve Injury Repair
Secondary ID [1] 291659 0
none
Universal Trial Number (UTN)
U1111-1195-3205
Trial acronym
ENSPN
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Peripheral Nerve Injury 302813 0
Condition category
Condition code
Injuries and Accidents 302309 302309 0 0
Other injuries and accidents
Surgery 302310 302310 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo microsurgical coaptation of injured peripheral nerves by the standard surgical technique with interrupted monofilament nylon suture of the epineruium. In our experimental group the repaired nerve will be stimulated by applying low frequency electric pulses to the nerve for 1 hour. After standard microsurgical repair of median or/and ulnar nerve injury is performed, two sterilized, stainless steel wires are placed proximal and distal to the coaptation site. These are secured to the skin with surgical suture material. The proximal wire is connected to the cathode and the distal wire to the anode port of the source of current calibrated to 20Hz balanced biphasic pulses, voltage: 3 volts, 1mA to 5mA current, duty cycle of 0.2%, continuous. Patients included in the trial will receive Low frequency continuous electric stimulation of the nerve for 1 hour as per protocol. In the placebo group, subjects will receive 5 seconds of similar intensity ES but the stimulator will be turned off for the remainder of the hour. In the mean time, surgical repair of other injury structures is performed. It is well documented that isolated traumatic nerve injury is frequently associated to vascular and musculoskeletal injuries. Standard closure of skin is performed . Electric stimulation wires are removed and standard dressings and immobilization applied. The entire procedure is performed under a general anaesthetic.
Intervention code [1] 297746 0
Treatment: Surgery
Intervention code [2] 297765 0
Treatment: Devices
Comparator / control treatment
All patients will receive current standard of care microsurgical repair of severed ulnar or median nerves. In the control group the electostimulation apparatus will be prepared and and applied as with the experimental group, but the machine will be turned off after 5 seconds of electrostimulation.
Control group
Placebo

Outcomes
Primary outcome [1] 301718 0
The primary outcomes assessed in this project will seek to quantify the effects of electric stimulation on motor and sensory nerve regeneration. This will be accomplished by assessing the following:

1) Motor Function - Hand Therapy assessment of motor function on a standard 0-5 power grading system for all relevant muscle groups / actions
Timepoint [1] 301718 0
We will collect data at 3 months , 6 months, 12 months and 24 months post intervention
Primary outcome [2] 301793 0
2) Sensory function --> Hand therapy assessment. Examination by formal SWME testing (semms - weinstein monofiliment examination )
Timepoint [2] 301793 0
We will collect data at 3 months , 6 months, 12 months and 24 months post intervention
Primary outcome [3] 301796 0
2) Neurophysiology --> Nerve conduction studies.
Timepoint [3] 301796 0
We will collect data at 3 months , 6 months, 12 months and 24 months post intervention
Secondary outcome [1] 333669 0
1) Patient Reported Outcomes (PRO) --> Michigan Hand Disability Test
Timepoint [1] 333669 0
We will assess patient reported outcomes at 3, 6, 12 and 24 months post-intervention
Secondary outcome [2] 333881 0
2) Pain and discomfort --> Hand therapy assessment. Standardised survey by assessment of pain on standard 0-10 analogue scale with 0 being no pain and 10 being the worst pain imaginable
Timepoint [2] 333881 0
We will assess pain discomfort in immediate postoperative setting 6h then at 3, 6, 12 and 24 months post-intervention

Eligibility
Key inclusion criteria
1. Age 18 to 70 years
2. Complete transection of the medial or/and ulnar nerve proximal to the wrist level.
3. Receiving surgery within 72 hours after injury.
4. Standard primary end-to-end nerve repair
5. Clinical indication for surgery under general anesthesia.
6. Informed, voluntary verbal and written consent obtained from patients.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Devascularization or amputation
2. Multilevel or segmental nerve injury
3. Diabetic and other polyneuropathies.
4. 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)
Allocation will be concealed by central randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2017
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7817 0
Dandenong Hospital - Dandenong
Recruitment hospital [2] 7818 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 7819 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 15750 0
3175 - Dandenong
Recruitment postcode(s) [2] 15751 0
3168 - Clayton
Recruitment postcode(s) [3] 15752 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 296160 0
Commercial sector/Industry
Name [1] 296160 0
Avant Mutual Group Limited - Avant medical Scholorship 2017
Country [1] 296160 0
Australia
Primary sponsor type
Individual
Name
Jeremy Wiseman
Address
Monash Health, Dandenong Hospital
135 David Street, Ward 1N, Department of Plastic and Reconstructive Surgery
Dandenong, Victoria 3175
Country
Australia
Secondary sponsor category [1] 295062 0
None
Name [1] 295062 0
Address [1] 295062 0
Country [1] 295062 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297404 0
Monash health HREC
Ethics committee address [1] 297404 0
Research Support Services I Monash Health
Level 2, I Block, Monash Medical Centre, Clayton, Victoria 3168
Ethics committee country [1] 297404 0
Australia
Date submitted for ethics approval [1] 297404 0
05/05/2017
Approval date [1] 297404 0
Ethics approval number [1] 297404 0

Summary
Brief summary
Functional outcomes of peripheral nerve injury using standard microsurgical repair alone are extremely poor despite the tremendous advances in surgery and medicine. These poor outcomes are due to the slow nerve regeneration process through the injury site and further growth to the target sites (muscle motor units, sensory and propioreceptors). In simple language, the muscle is an electric motor that needs continual supply of electricity to keep it running in good condition. The nerve is the electric wire and the nerve impulse is the electricity. When there is an injury to the nerve the electric wire is divided and the motor cannot work. The motor will deteriorate and weaken irreversibly if the re-establishment of electricity supply is too slow. When the electricity supply is re-established within a time interval short enough to prevent irreversible damage of the motor, the reconditioned and weaken motor will run again. We hypothesise that the process of regeneration can be enhanced and sped up by electrical stimulation of the repaired nerve intraoperatively. We plan to test this hypothesis in patients suffering from ulnar and median nerve injury. They will undergo microsurgical repair of the nerve under general aesthetic as routine practice and then receive intra-operative low frequency electric stimulation of the repaired nerve for 1 hour. Functional outcomes of patients randomised to receive the experimental treatment will be compared with controls (patients who receive nerve repair alone) over the course of a 24 month follow up period allowing us to determine if the added therapy translates into clinically beneficial outcomes.
Trial website
none
Trial related presentations / publications
none
Public notes
Attachments [1] 1624 1624 0 0
/AnzctrAttachments/372719-PatientInformationSheetElectricStimulationV1.docx (Participant information/consent)
Attachments [2] 1625 1625 0 0
/AnzctrAttachments/372719-Protocol.docx (Protocol)

Contacts
Principal investigator
Name 73934 0
Dr Jeremy Wiseman
Address 73934 0
Dandenong Hospital
135 David Street
Dandenong, Victoria 3175
Country 73934 0
Australia
Phone 73934 0
+61402605292
Fax 73934 0
+613 97927728
Email 73934 0
[email protected]
Contact person for public queries
Name 73935 0
Jeremy Wiseman
Address 73935 0
Dandenong Hospital
135 David Street
Dandenong, Victoria 3175
Country 73935 0
Australia
Phone 73935 0
+61 402605292
Fax 73935 0
+613 97927728
Email 73935 0
[email protected]
Contact person for scientific queries
Name 73936 0
Jeremy Wiseman
Address 73936 0
Dandenong Hospital
135 David Street
Dandenong, Victoria 3175
Country 73936 0
Australia
Phone 73936 0
+614 02605292
Fax 73936 0
+613 97927728
Email 73936 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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