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
DOI	https://doi.org/10.1186/ISRCTN92118149
Clinical Trials Information System (CTIS)	2007-003902-84
Protocol serial number	N/A
Sponsor	University of Leeds (UK)
Funder	Cancer Research UK (UK) (ref: C18324/A7715)

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-to-see-if-a-nerve-stimulating-machine-called-tens-can-control-bone-cancer-pain

Contact information

Dr Mike Bennett
Scientific

St Gemma's Hospice
329 Harrogate Road
Leeds
LS17 6QD
United Kingdom

Phone	+44 (0)113 218 5500
Email	m.bennett@st-gemma.co.uk

Study information

Primary study design	Interventional
Study design	Two-arm, crossover, prospective, randomised, controlled, external pilot study
Secondary study design	Randomised controlled trial
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(s)	1. Pain at rest one hour after starting TENS application 2. Pain at movement one hour after starting TENS application
Key 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
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex
Target sample size at registration	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

United Kingdom
England

Study participating centre

St Gemma's Hospice

Leeds
LS17 6QD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No
Plain English results				No	Yes

Editorial Notes

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)