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Trial registered on ANZCTR


Registration number
ACTRN12609000776202
Ethics application status
Approved
Date submitted
9/11/2008
Date registered
7/09/2009
Date last updated
7/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of interactive neurostimulation in the management of acute postoperative pain following a total hip replacement – a pilot randomized controlled trial
Scientific title
The effect of Interactive Neurostimulation in altering acute pain following a total hip replacement as measured by pain scores on a numerical rating scale
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total hip replacement 3956 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4150 4150 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interactive neurostimulation will be applied using the InterX 5002 device, to the skin anterior to the surgical incision, inferior to the surgical incision and the buttock area. Using a minimal intensity of stimulation, the area will be scanned to identify the area with lowest impedance. At this location, the device will be held stationary and the intensity will be increased until the patient feels a strong but comfortable sensation. The interactive neurostimulation will be administered once a day, in the morning for the five days following the participant’s total hip replacement, or until discharged. Each session will be 20-30 mins, determined when the device registers an adequate change in impedance level."
Intervention code [1] 3670 0
Treatment: Devices
Comparator / control treatment
Interactive Neurostimulation (INS) sham device – The sham group will receive the same treatment protocol using an InterX 5002 sham device, which has an identical appearance to the active device with lights, buzzing and beeps, but does not deliver INS. Participants will be administered the sham treatment once a day in the morning on the five days following total hip replacement or until discharged. Each session will be 20-30 mins.
Control group
Placebo

Outcomes
Primary outcome [1] 5046 0
Pain scores collected on a numerical rating score.
Timepoint [1] 5046 0
Every day for five days post surgery.
Primary outcome [2] 5047 0
Analgesic consumption - Total daily consumption (mg) obtained from patient's daily case notes.
Timepoint [2] 5047 0
Every day for five days post surgery.
Secondary outcome [1] 8492 0
Range of motion at the affected hip joint - Assessed before and after intervention by a physiotherapist using a goniometer to measure degrees of movement into flexion, extension abduction and adduction.
Timepoint [1] 8492 0
Every day for five days post surgery.
Secondary outcome [2] 8493 0
Length of hospital stay - As determined by patient's case notes. Length of hospital stay will be calculated by considering the number of days from the operation until discharge. Day 1 will be the day of the operation and that night. The day the patients are discharged will be counted as the final day.
Timepoint [2] 8493 0
When discharged from the hospital where surgery was performed.

Eligibility
Key inclusion criteria
Aged between 40 and 75 years old.
Undergoing a standard total hip replacement (THR) and available day 1 post-operatively.
Capable and willing to give informed consent during pre-admission.
Minimum age
40 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any condition that is a contra-indication to the application of electrical stimulation including the presence of an insulin pump or implanted functioning device, history of epilepsy or seizure, presence of active cancerous tissue or undergoing chemotherapy.
A THR for systemic arthritides such as Rheumatoid Arthritis, or trauma such as a fractured neck of femur.
A revision THR.
Any intra-operative or post-operative complications such as bone grafts, deep vein thrombosis, post operative confusion that may affect post operative rehabilitation

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)
All attendants at the total hip replacement pre-admission clinic at the Repatriation General Hospital in and January 2009 will be approached. Those who meet the inclusion criteria and do not meet the exclusion criteria will be accepted, until numbers are filled. Allocation concealment via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Participants will be stratified into male and female groups. Within these groups, each participant will receive a random envelope, assigned after shuffling.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4135 0
Self funded/Unfunded
Name [1] 4135 0
Address [1] 4135 0
Country [1] 4135 0
Primary sponsor type
Individual
Name
Catherine Norman
Address
8 Grenada Court WEST LAKES SA 5021
Country
Australia
Secondary sponsor category [1] 3720 0
Individual
Name [1] 3720 0
Lucy Chipchase
Address [1] 3720 0
Level 8 (C8-54) Centenary building, University of South Australia, City East Campus, North Terrace
ADELAIDE SA 5000
Country [1] 3720 0
Australia
Other collaborator category [1] 470 0
Hospital
Name [1] 470 0
Repatriation General Hospital
Address [1] 470 0
Repatriation General Hospital
216 Daws Road
Daw Park SA 5041
Country [1] 470 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6205 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 6205 0
University of South Australia, City East Campus, North Terrace
ADELAIDE SA 5000
Ethics committee country [1] 6205 0
Australia
Date submitted for ethics approval [1] 6205 0
10/09/2008
Approval date [1] 6205 0
25/09/2008
Ethics approval number [1] 6205 0
P239/08

Summary
Brief summary
To determine the effectiveness of an electrotherapy device called Interactive Neurostimulation (INS), in providing pain relief following a total hip replacement.

Outcome measures are pain scores, length of hospital stay, analgesic use and/or increase range of movement in the acute period following a total hip replacement.

The null hypothesis is that there will be no difference in each variable between the active INS and sham groups five days after surgery.

The research hypothesis is that there will be a difference in each variable between the active INS and sham groups five days after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29113 0
Address 29113 0
Country 29113 0
Phone 29113 0
Fax 29113 0
Email 29113 0
Contact person for public queries
Name 12270 0
Catherine Norman
Address 12270 0
University of South Australia, Department of Health Sciences, Level 8 Centenary Building, City East Campus, North Terrace
ADELAIDE SA 5000
Country 12270 0
Australia
Phone 12270 0
+61 410 853 483
Fax 12270 0
Email 12270 0
norca003@students.unisa.edu.au
Contact person for scientific queries
Name 3198 0
Catherine Norman
Address 3198 0
University of South Australia, Department of Health Sciences, Level 8 Centenary Building, City East Campus, North Terrace
ADELAIDE SA 5000
Country 3198 0
Australia
Phone 3198 0
+61 410 853 483
Fax 3198 0
Email 3198 0
norca003@students.unisa.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary