To evaluate the effects of Manual Lymphatic Drainage on limb volume and quality of life when used in addition to standard lymphoedema therapy.

ISRCTN ISRCTN13391637
DOI https://doi.org/10.1186/ISRCTN13391637
Secondary identifying numbers N0040122626
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
18/08/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Gloria Shingler
Scientific

Breast Cancer Specialist Nurse Counsellor
Bedford Hospital NHS Trust
South Wing
Kempston
Bedford
MK42 9DJ
United Kingdom

Phone +44 (0)1234 355122 ext 2041
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTo evaluate the effects of Manual Lymphatic Drainage on limb volume and quality of life when used in addition to standard lymphoedema therapy.
Study objectivesTo evaluate quality of life of patients with upper limb lymphoedema secondary to breast cancer, when Manual Lympathetic Drainage message is added to the standard Lymphoedema therapy using a quantitative validated questionnaire SF36
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Lymphoedema
InterventionManual Lymphatic Drainage and standard lymphoedema therapy vs standard lymphoedema therapy only
Intervention typeProcedure/Surgery
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/2003
Completion date15/04/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants120
Key inclusion criteriaA clinic list of 120 patients with 3-6 monthly appointments
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/02/2003
Date of final enrolment15/04/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Bedford Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan