Cancer bone pain Cancer Cancer bone pain
Conditions
Interventions
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 r
Sponsors
University of Leeds (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain at rest one hour after starting TENS application 2. Pain at movement one hour after starting TENS application | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed