Wearable textile with integrated electrotherapy for joint pain management

Not Applicable

• Conditions: Musculoskeletal Diseases; Knee osteoarthritis

• Registration Number: ISRCTN94599670
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-17
• Last Update Posted: 30 September 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Adults between 45 and 70 years of age2. Diagnosed with knee OA according to American College of Rheumatology criteria3. Pain score ranging from 3 to 7 on the Visual Analog Scale (VAS)4. Participants will not have prior experience with TENS or other electrotherapy (e.g. interferential therapy) 5. Able to stand up unaided6. Willing and able to give informed consent

Exclusion Criteria

1. Prior major knee surgery (i.e. partial or total knee arthroplasty)2. Anticipated surgery during the study (no anticipated surgery during the 12 weeks of the study)3. Skin sensitivities and sensation problems4. Uncontrolled epilepsy5. Those who are pregnant; planning to become pregnant or are breastfeeding6. An active device implant (e.g. pacemaker user)7. A stent in the lower limb

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured using a Visual Analogue Scale (VAS) at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures will be assessed at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks 1. Patient-reported pain, joint stiffness and physical function measured using the VAS, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Oxford Knee Score (OKS)2. Health-related quality of life measured using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)