|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
|
| [ ...Back to search results ] | [ Print-friendly version ] |
| 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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN92118149 |
| Date ISRCTN assigned | 03/10/2007 |
| Local reference number(s) | N/A |
| Public title | 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 |
| Scientific title | |
| Acronym | TENS FEASIBILITY |
| Disease/condition/study domain | Cancer bone pain |
| Study hypothesis | 1. Does Transcutaneous Electrical Nerve Stimulation (TENS) have analgesic benefits in people with cancer bone pain? 2. In people with cancer bone pain, does TENS produce analgesic benefits at rest, on movement or both? |
| Design/methodology | Two-arm, crossover, prospective, randomised, controlled, external pilot study |
| Research ethics review | Appoval granted from Leeds (west) Research Ethics Committee on 28th March 2007 (REC ref: 07/Q1205/5). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 04/06/2007 |
| Anticipated end date | 01/12/2007 |
| Status of trial | Completed |
| Target number of participants | 38 |
| 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 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. |
| Primary outcome measure(s) | 1. Pain at rest one hour after starting TENS application 2. Pain at movement one hour after starting TENS application |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Cancer Research UK (UK) (ref: C18324/A7715) |
| Sponsor name | University of Leeds (UK) |
| Sponsor details | Room 7.11, Level 7 Worsley Building Clarendon Way Leeds United Kingdom LS2 9NL |
| Sponsor website | http://www.leeds.ac.uk/ |
| Contact name | Dr Mike Bennett |
| Contact details | St Gemma's Hospice 329 Harrogate Road Leeds United Kingdom LS17 6QD |
| Contact telephone | +44 (0)113 218 5500 |
| Contact fax | +44 (0)113 218 5502 |
| Contact email | m.bennett@st-gemma.co.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN92118149 |
| Date last extracted from ISRCTN register | 17/04/2008 |
|
|
|
|
|
| © 2012 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | |
|
|
|
|