- Design
- Randomised, sham-controlled superiority trial
- Population
- 96 people with knee osteoarthritis doing an exercise therapy programme
- Primary outcome
- KOOS Pain subscale after the programme and at 1 month
- Effect
- Mean difference 1.05 points (95% CI -5.19 to 7.29); at 1 month 0.40 (-5.91 to 6.71)
This randomised, sham-controlled trial assigned 96 people with knee osteoarthritis to exercise therapy plus active high-frequency transcutaneous electrical nerve stimulation or exercise plus sham stimulation. The primary outcome was the KOOS pain subscale, measured after the programme and at one month.
Active TENS did not add benefit: the adjusted mean difference was 1.05 points after the programme (95% CI -5.19 to 7.29) and 0.40 points at one month (-5.91 to 6.71). The intervals did not reach the predefined 10-point minimal clinically important difference, and no secondary outcome differed. No adverse effects were reported.
The authors note that blinding was not formally assessed, follow-up was short, and there was no exercise-only arm, so the trial speaks to TENS as an add-on, not to exercise itself. Supervised exercise remains the core of knee osteoarthritis care. Spending clinic time and money on TENS during exercise is hard to justify from this result.
- Prioritise a structured exercise programme for knee osteoarthritis.
- Do not add high-frequency TENS to exercise expecting extra pain relief.
- Address adherence barriers, including movement-evoked pain, with graded loading and education.
- Add weight management where relevant and use analgesics according to guideline.
Why it matters
Adjunct electrotherapy is widely offered, and a well-run sham-controlled trial found nothing added.
Don't overread it
The trial tested one TENS protocol over a short follow-up and does not rule out benefit from other settings or longer use.
The statistics, in plain English
The 95% interval (-5.19 to 7.29) lies well within the 10-point threshold for a meaningful difference on both sides, so a large effect is unlikely, though a small one is not excluded. Without an exercise-only group, the trial cannot say how much exercise alone helped.
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