Plain English Summary
Study website
Contact information
Type
Scientific
Contact name
Dr Mike Bennett
ORCID ID
Contact details
St Gemma's Hospice
329 Harrogate Road
Leeds
LS17 6QD
United Kingdom
+44 (0)113 218 5500
m.bennett@st-gemma.co.uk
Additional identifiers
EudraCT/CTIS number
2007-003902-84
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
TENS FEASIBILITY
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?
Ethics approval(s)
Leeds (west) Research Ethics Committee on 28/03/2007 (REC ref: 07/Q1205/5)
Study design
Two-arm, crossover, prospective, randomised, controlled, external pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Not Specified
Target number of participants
38
Participant 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
Recruitment start date
04/06/2007
Recruitment end date
01/12/2007
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
St Gemma's Hospice
Leeds
LS17 6QD
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Room 7.11
Level 7
Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK) (ref: C18324/A7715)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/04/2010 | Yes | No |