Electrical Stimulation treating knee osteoarthritis for pain, function and strength

A double blind, randomised, sham-controlled trial investigating the effects of combining electrical stimulation of the calf and thigh muscles in patients with osteoarthritis of the knee

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12112819

Enrollment

193

Registered

2019-05-01

Start date

2019-05-20

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Osteoarthritis of the knee Musculoskeletal Diseases Arthrosis

Interventions

Participants are randomised by a computer-generated system to one of two groups: 1. Revitive device 2. Sham device This will be a blinded study, therefore, participants will not know which device the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. OA diagnosed clinically in accordance with NICE guidance. 2. Aged 45-85 years.

Exclusion criteria

Exclusion criteria: 1. Fitted with an electronic implant such as a pacemaker or defibrillator. 2. Pregnant. 3. Existing or undergoing treatment for DVT. 4. Significantly impaired cognitive ability. 5. Inflammatory arthritis. 6. Dermatological conditions affecting the feet or legs. 7. Neurological disorder affecting the feet or legs. 8. Significant osteoarthritis of the hip, ankle or foot. 9. Current or recent knee surgery, trauma or injury (last 3 months). 10. Previous corticosteroid or hyaluronic acid injections (last 6 months). 11. BMI over 40. 12. Use of transcutaneous electrical stimulation. 13. Use of neuromuscular electrical stimulation device.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 13/05/2022: The pain domain of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. The primary end point of the trial is week 8. Previous primary outcome measure: Osteoarthritis is measured using The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 1 and week 8.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 13/05/2022: 1. Self-Reported Knee Pain, Function and Stiffness is measured by the WOMAC and Oxford Knee score 2. Health status will be measured by the 36-Item Short Form Survey (SF-36), EuroQol 5-Dimension 5-Level health questionnaire (EQ-5D-5L), Medical Outcome Study Sleep Scale (MOS Sleep) and Hospital Anxiety and Depression Score (HADS) 3. Muscle strength will be measured by means of isokinetic dynamometer at week 1 and week 8. 4. Swelling will be measured through joint line circumferences of the knee and ankle at week 1 and week 8. 5. Pain at rest and during movement will be measured using the visual analogue scale (VAS) at week 1 and week 8. 6. Physical activity will be measured using accelerometers worn around the waist at week 0 and week 7. (added 19/05/2022) 7. Functional performance is measured via the incremental shuttle walk (ISWT), endurance shuttle walk (ESWT)and the short performance physical battery (SPPB) at week 1 and week 8 Previous secondary outcome measures: 1. Health-related quality of life is measured via the Oxford Knee Score, EQ-5D, SF-36 and Pittsburgh sleep quality index at week 1 and week 8. 2. Functional performance is measured via the incremental shuttle walk (ISWT), endurance shuttle walk (ESWT)and the short performance physical battery (SPPB) at week 1 and week 8. 3. Muscle strength will be measured by means of isokinetic dynamometer at week 1 and week 8. 4. Swelling will be measured through joint line circumferences of the knee and ankle at week 1 and week 8. 5. Pain at rest and during movement will be measured using the visual analogue scale (VAS) at week 1 and week 8. 6. Physical activity will be measured using accelerometers worn around the waist at week 0 and week 7.	—

Measure

Time frame

Current secondary outcome measures as of 13/05/2022: 1. Self-Reported Knee Pain, Function and Stiffness is measured by the WOMAC and Oxford Knee score 2. Health status will be measured by the 36-Item Short Form Survey (SF-36), EuroQol 5-Dimension 5-Level health questionnaire (EQ-5D-5L), Medical Outcome Study Sleep Scale (MOS Sleep) and Hospital Anxiety and Depression Score (HADS) 3. Muscle strength will be measured by means of isokinetic dynamometer at week 1 and week 8. 4. Swelling will be measured through joint line circumferences of the knee and ankle at week 1 and week 8. 5. Pain at rest and during movement will be measured using the visual analogue scale (VAS) at week 1 and week 8. 6. Physical activity will be measured using accelerometers worn around the waist at week 0 and week 7. (added 19/05/2022) 7. Functional performance is measured via the incremental shuttle walk (ISWT), endurance shuttle walk (ESWT)and the short performance physical battery (SPPB) at week 1 and week 8 Previous secondary outcome measures: 1. Health-related quality of life is measured via the Oxford Knee Score, EQ-5D, SF-36 and Pittsburgh sleep quality index at week 1 and week 8. 2. Functional performance is measured via the incremental shuttle walk (ISWT), endurance shuttle walk (ESWT)and the short performance physical battery (SPPB) at week 1 and week 8. 3. Muscle strength will be measured by means of isokinetic dynamometer at week 1 and week 8. 4. Swelling will be measured through joint line circumferences of the knee and ankle at week 1 and week 8. 5. Pain at rest and during movement will be measured using the visual analogue scale (VAS) at week 1 and week 8. 6. Physical activity will be measured using accelerometers worn around the waist at week 0 and week 7.

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026