None listed
Conditions
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.
Interventions
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 d
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."
Sponsors
Catherine Norman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
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.
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
Outcome results
None listed