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 |
| Protocol serial number | N0040122626 |
| Sponsor | Department of Health (UK) |
| Funder | Bedford Hospital NHS Trust (UK) |
- 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
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 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | To evaluate the effects of Manual Lymphatic Drainage on limb volume and quality of life when used in addition to standard lymphoedema therapy. |
| Study objectives | To 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) studied | Cardiovascular: Lymphoedema |
| Intervention | Manual Lymphatic Drainage and standard lymphoedema therapy vs standard lymphoedema therapy only |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | A clinic list of 120 patients with 3-6 monthly appointments |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 15/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom
MK42 9DJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
