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
ISRCTN | ISRCTN92118149 |
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DOI | https://doi.org/10.1186/ISRCTN92118149 |
EudraCT/CTIS number | 2007-003902-84 |
Secondary identifying numbers | N/A |
- Submission date
- 05/07/2007
- Registration date
- 03/10/2007
- Last edited
- 26/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Mike Bennett
Scientific
Scientific
St Gemma's Hospice
329 Harrogate Road
Leeds
LS17 6QD
United Kingdom
Phone | +44 (0)113 218 5500 |
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m.bennett@st-gemma.co.uk |
Study information
Study design | Two-arm, crossover, prospective, randomised, controlled, external pilot study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific 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 |
Study acronym | TENS FEASIBILITY |
Study objectives | 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? |
Ethics approval(s) | Leeds (west) Research Ethics Committee on 28/03/2007 (REC ref: 07/Q1205/5) |
Health condition(s) or problem(s) studied | 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. |
Intervention type | Other |
Primary outcome measure | 1. Pain at rest one hour after starting TENS application 2. Pain at movement one hour after starting TENS application |
Secondary outcome measures | 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 |
Overall study start date | 04/06/2007 |
Completion date | 01/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 38 |
Key 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 Gemmas 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 |
Key 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 |
Date of first enrolment | 04/06/2007 |
Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Gemma's Hospice
Leeds
LS17 6QD
United Kingdom
LS17 6QD
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Room 7.11, Level 7
Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
Website | http://www.leeds.ac.uk/ |
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https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Cancer Research UK (UK) (ref: C18324/A7715)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Plain English results | No | Yes | |||
Results article | results | 01/04/2010 | Yes | No |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)