Condition category
Surgery
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
27/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Melissa Domaille

ORCID ID

Contact details

Rheumatology Centre
The Courtyard
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R/19/3-95/BYRNE

Study information

Scientific title

A randomised controlled trial to investigate the effectiveness of transcutaneous electrical nerve stimulation on pain control post-sternotomy

Acronym

Study hypothesis

To investigate the effectiveness of transcutaneous electrical nerve stimulation (TENS) in reducing pain after cardiac surgery with sternotomy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular diseases: Heart disease; Symptoms and general pathology: Pain

Intervention

1. Transcutaneous electrical nerve stimulation
2. Standard care

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1995

Overall trial end date

31/05/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/1995

Recruitment end date

31/05/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology Centre,
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

27/09/2016: No publications found, verifying study status with principal investigator