Condition category
Cancer
Date applied
05/07/2007
Date assigned
03/10/2007
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

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 number

2007-003902-84

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

04/06/2007

Overall trial end date

01/12/2007

Reason abandoned

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 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

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

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

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19853518

Publication citations

  1. Results

    Bennett MI, Johnson MI, Brown SR, Radford H, Brown JM, Searle RD, Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain., J Pain, 2010, 11, 4, 351-359, doi: 10.1016/j.jpain.2009.08.002.

Additional files

Editorial Notes