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

INTERVENTION: Active TENS versus placebo TENS. Patients will be randomised to receive either active or sham TENS at site of pain for one hour. They will then receive the other in a second treatment. Patients and research nurses will be blinded. There are two treatment sessions each lasting 1.5 hours, the treatment sessions are separated by a minimum of 48 hours. The follow‐up session is performed over the telephone 48 hours after the final treatment session. CONDITION: Cancer bone pain ; Cancer ; Cancer bone pain PRIMARY OUTCOME: 1. Pain at rest one hour after starting TENS application; 2. Pain at movement one hour after starting TENS application SECONDARY OUTCOME: 1. Recruitment and screening of patients to determine recruitment strategy for the phase III clinical trial: the timepoint measurement of this outcome is continuous; as it is a feasibility study we need to look at the barriers (if any) to palliative care research. A detailed screening and enrolment log is maintained for this purpose; 2. Optimal electrode placement: this measurement will be performed at each treatment visit following the baseline assessment; 3. Patients? experience: this will be assessed at the end of each treatment period following 60 minutes of TENS treatment; 4. Toxicity: this will be assessed throughout each treatment session and again at the follow up telephone review INCLUSION CRITERIA: 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