Abstract
Introduction: This feasibility study aimed to 1) develop a clinical protocol using a LTP-like (long term potentiation) repetitive stimulation protocol for transcutaneous electrical nerve stimulation (TENS) in patients with upper limb complex regional pain syndrome (CRPS) and 2) develop a research protocol for a single-blind randomised controlled trial (RCT) investigating the efficacy of TENS for CRPS.
Methods: This small-scale single-blind feasibility RCT planned to randomise 30 patients with upper limb CRPS to either a variant of TENS or placebo TENS for 3 weeks. Stimulation comprised 20 pulses over 1-second with a non-stimulation interval of 5-seconds, a so-called repetitive electrical stimulation protocol following the timing of LTP. Pain, function and body image were measured at baseline, post-treatment and 3-months follow-up. At 3-months, participants were invited to one-to-one interviews, which were analysed thematically.
Results: A TENS protocol with electrodes applied proximal to the area of allodynia in the region of the upper arm was developed. Participant concordance with the protocol was high. The sample size was small (TENS (n=6), placebo (n=2)). Mean (SD) pain intensity for the TENS group on a 0-10 scale was 7.2 (2.4), 6.6 (2.8), and 7.8 (1.9), at baseline, post-treatment and 3-month follow-up respectively. Qualitative data suggested some patients found TENS beneficial, easy to use, and were still using at 3-months.
Discussion: Patients tolerated TENS well and important methodological information to facilitate the design of a large-scale trial was obtained. [ISRCTN48768534]
Methods: This small-scale single-blind feasibility RCT planned to randomise 30 patients with upper limb CRPS to either a variant of TENS or placebo TENS for 3 weeks. Stimulation comprised 20 pulses over 1-second with a non-stimulation interval of 5-seconds, a so-called repetitive electrical stimulation protocol following the timing of LTP. Pain, function and body image were measured at baseline, post-treatment and 3-months follow-up. At 3-months, participants were invited to one-to-one interviews, which were analysed thematically.
Results: A TENS protocol with electrodes applied proximal to the area of allodynia in the region of the upper arm was developed. Participant concordance with the protocol was high. The sample size was small (TENS (n=6), placebo (n=2)). Mean (SD) pain intensity for the TENS group on a 0-10 scale was 7.2 (2.4), 6.6 (2.8), and 7.8 (1.9), at baseline, post-treatment and 3-month follow-up respectively. Qualitative data suggested some patients found TENS beneficial, easy to use, and were still using at 3-months.
Discussion: Patients tolerated TENS well and important methodological information to facilitate the design of a large-scale trial was obtained. [ISRCTN48768534]
| Original language | English |
|---|---|
| Pages (from-to) | 52-63 |
| Journal | Hand Therapy |
| Volume | 22 |
| Issue number | 2 |
| Early online date | 7 Nov 2016 |
| DOIs | |
| Publication status | Published - 1 Jun 2017 |
Keywords
- feasibility study
- upper limb
- complex regional pain syndrome
- TENS