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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94599670

Enrollment

100

Registered

2024-09-17

Start date

2025-02-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis Musculoskeletal Diseases

Interventions

Wearable Textile with Integrated Electrotherapy for Joint Pain Management. Participants will be randomly allocated to treatment or control (sham treatment) in a 1:1 ratio according to a randomisation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 20/01/2025: 1. Adults between 45 and 75 years of age 2. Diagnosed with knee OA according to American College of Rheumatology criteria 3. 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 unaided 6. Willing and able to give informed consent _____ Previous inclusion criteria: 1. Adults between 45 and 70 years of age 2. Diagnosed with knee OA according to American College of Rheumatology criteria 3. 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 unaided 6. Willing and able to give informed consent

Exclusion criteria

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 problems 4. Uncontrolled epilepsy 5. Those who are pregnant; planning to become pregnant or are breastfeeding 6. An active device implant (e.g. pacemaker user) 7. A stent in the lower limb

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Countries

England, United Kingdom

Contacts

Public ContactKai Yang

ky2e09@soton.ac.uk+44 (0)2380591654

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026