OA-Tex TENS Stimulator
Research type
Research Study
Full title
Wearable textile with integrated electrotherapy for joint pain management - Efficacy of electronic textile based transcutaneous nerve stimulation (TENS) in patients with knee pain due to osteoarthritis: a pilot randomised controlled trial
IRAS ID
335669
Contact name
Elaine Dennison
Contact email
Sponsor organisation
University Hospital Southampton
ISRCTN Number
ISRCTN94599670
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Osteoarthritis (OA) is the most common musculoskeletal condition, with knee OA being the most prevalent. People with knee OA in the UK are predicted to increase from 4.7 to 8.3 million by 2035. Knee joint pain typically reduces physical activity, independence, and quality of life. Currently knee OA pain is managed by medication (NSAIDs/opioids) which costs £195.3 million p.a. However, medication may cause serious side effects. Uncontrolled pain ultimately may necessitate joint arthroplasty. 106,572 primary knee replacements were performed in 2019, 98% of which resulted from knee OA, costing ~£800 million p.a. in the UK.
This project aims to develop an electrotherapy product, based on a wearable garment, to relieve knee OA pain through transcutaneous electrical nerve stimulation (TENS).
The TENS is integrated into a discreet and aesthetic garment for everyday use. The product is operated by a wired controller unit. The product will allow users to manage their pain wherever and whenever required. This will lead to better patient outcomes while reducing healthcare costs.
The product will be co-developed with end users who will iteratively feedback their user requirements and test prototypes.
A home usability test will be conducted to ensure the product is suitable for independent use in the home environment.
A pilot Randomized Controlled Trial (RCT) will be conducted to establish efficacy in pain management and inform a future definitive RCT. An ISO13485 Quality Management System (QMS) and technical documentation will be developed to demonstrate compliance with UK and EU Medical Device Regulations.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0358
Date of REC Opinion
20 Dec 2024
REC opinion
Further Information Favourable Opinion