To determine the additional effects of transcutaneous electrical nerve stimulation (TENS) for knee osteoarthritis (OA) when combined with a group education and exercise program (knee group).
The study was a randomized, sham-controlled clinical trial. Patients referred for physiotherapy with suspected knee OA (confirmed using the American College of Rheumatology clinical criteria) were invited. Exclusion criteria included comorbidities preventing exercise, previous TENS experience, and TENS contraindications. Prospective sample size calculations required 67 participants in each trial arm. A total of 224 participants (mean age 61 years, 37% men) were randomized to 3 arms: TENS and knee group (n = 73), sham TENS and knee group (n = 74), and knee group (n = 77). All patients entered an evidence-based 6-week group education and exercise program (knee group). Active TENS produced a "strong but comfortable" paraesthesia within the painful area and was used as much as needed during the 6-week period. Sham TENS used dummy devices with no electrical output. Blinded assessment took place at baseline and 3, 6, 12, and 24 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale at 6 weeks. Secondary outcomes included WOMAC pain, stiffness, and total scores; extensor muscle torque; global assessment of change; exercise adherence; and exercise self-efficacy. Data analysis was by intent to treat.
All outcomes improved over time (P < 0.05), but there were no differences between trial arms (P > 0.05). All improvements were maintained at 24-week followup.
There were no additional benefits of TENS, failing to support its use as a treatment adjunct within this context.