Transcutaneous Electrical Nerve Stimulation in the management of cancer bone pain II: a two-arm, crossover, prospective, randomised, controlled, external pilot study for patients with cancer bone pain

niversity of Leeds (UK)0 sites38 target enrollmentOctober 3, 2007

Overview

Registry

who.int

Start Date

October 3, 2007

End Date

December 1, 2007

Last Updated

7 years ago

Study Type

Interventional

Sponsor

niversity of Leeds (UK)

•Patients who:
•1\. Have a radiologically evident bone metastasis
•2\. Experience pain from a bone metastasis that affects their activities of daily living (e.g., transferring from sitting to standing, bending over, walking or dressing upper body)
•3\. Experience pain that is rated at least 3 out of 10 on a numerical pain intensity rating scale at rest or on movement on first visit
•4\. Are aged 18 years or over
•5\. Have provided written informed consent and are willing to attend St Gemma?s Hospice for study periods
•6\. Are willing and able to complete patient assessments and pain scores
•7\. In the opinion of the investigator the patient will derive potential benefit from the use of TENS
•8\. Have an estimated survival of longer than four weeks

•Patients who:
•1\. Are unable to complete patient related information on entry
•2\. Do not have ongoing cancer
•3\. Are unable to provide informed consent (for physical or psychiatric reasons)
•4\. Are not suitable for TENS as described by the Chartered Society of Physiotherapy (CSP) Standards for the Use of Electrophysical Modalities. This includes patients fitted with pacemakers and patients who are pregnant or have epilepsy. Patients with abnormal sensation over the site of pain will also be excluded under CSP criteria
•5\. Have had changes to opioid analgesic medication (increase or decrease in opioid dose of 30%, addition or removal of opioid) within 48 hours prior to baseline assessment
•6\. Have received TENS within the previous four weeks