TENS for patients with Complex regional pain syndrome

• Research type

  Research Study

• Full title

  Transcutaneous Electrical Nerve Stimulation (TENS) for patients with upper limb complex regional pain syndrome: A feasibility study.

• IRAS ID

  133368

• Contact name

  Cormac Ryan

• Contact email

  c.ryan@tees.ac.uk

• Research summary

  National Complex Regional Pain Syndrome (CRPS) guidelines identify the potential of Transcutaneous Electrical Nerve Stimulation (TENS) as a treatment. Theoretical evidence on mechanisms of pain and body image disruption within the brain further suggests that TENS would be useful for CRPS. However, there is no RCT-level evidence to substantiate or refute such claims. Also, our discussions with clinicians have identified that CRPS patients are unlikely to tolerate having adhesive pads attached to the painful site. To overcome that practical barrier TENS could be applied through pads placed above the affected area, and as such, could be offered to patients for home-use. Therefore, to address the practical issues and the evidence gap this study aims to:

  1.Develop a clinical protocol for TENS specifically for people with upper limb CRPS to use at home
  2.Assess recruitment rates/procedures, blinding procedures, outcome measures, and estimate effect-sizes in order to develop an RCT investigating the effectiveness of TENS for CRPS

  This feasibility study will incorporate a small-scale single-blind RCT combined with a qualitative study. 30 people with upper limb CRPS will be recruited from local NHS services and randomised to either TENS (n=15) or a placebo (n=15). Following one session of training from a physiotherapist participants will use TENS or placebo at home for 3 weeks. Data will be collected on pain, function and body image at baseline, post treatment and 3 months follow-up. At three months follow-up, each participant will be invited to a one-to-one interview to give their opinion of the trial procedures and the interviews will be analysed thematically.

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0286

• Date of REC Opinion

  23 Oct 2013

• REC opinion

  Further Information Favourable Opinion