Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain.
This multicenter study assessed the feasibility of conducting a phase III trial of transcutaneous electrical nerve stimulation (TENS) in patients with cancer bone pain recruited from palliative care services. Eligible patients received active and placebo TENS for 1 hour at site of pain in a randomized crossover design; median interval between applications 3 days. Responses assessed at 30 and 60 minutes included numerical and verbal ratings of pain at rest and on movement, and pain relief. Recruitment, tolerability, adverse events, and effectiveness of blinding were also evaluated. Twenty-four patients were randomised and 19 completed both applications. The intervention was well tolerated. Five patients withdrew: 3 due to deteriorating performance status, and 2 due to increased pain (1 each following active and placebo TENS). Confidence interval estimation around the differences in outcomes between active and placebo TENS suggests that TENS has the potential to decrease pain on movement more than pain on rest. Nine patients did not consider that a placebo was used; the remaining 10 correctly identified placebo TENS. Feasibility studies are important in palliative care prior to undertaking clinical trials. Our findings suggest that further work is required on recruitment strategies and refining the control arm before evaluating TENS in cancer bone pain.


CONCLUSIONS
Cancer bone pain is common and severe, and partly mediated by hyperexcitability. Animal studies suggest that Transcutaneous Electrical Nerve Stimulation can reduce hyperalgesia. This study examined the feasibility of evaluating TENS in patients with cancer bone pain in order to optimize methods before a phase III trial.
Bennett
Michael I
MI
Professor of Palliative Medicine, Lancaster University, Lancaster, United Kingdom. m.i.bennett@lancaster.ac.uk
Johnson
Mark I
MI
Brown
Sarah R
SR
Radford
Helen
H
Brown
Julia M
JM
Searle
Robert D
RD
D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000150:complications* / Q000556:secondary*; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement; D010148:Intractable Pain / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D010166:Palliative Care / Q000379:methods / Q000706:statistics & numerical data; D018579:Patient Selection; D010865:Pilot Projects; D015990:Placebo Effect; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods* / Q000706:statistics & numerical data; D016896:Treatment Outcome