Lower limb lymphoedema caused by either
Conditions
Interventions
19 districts in Bangladesh and 20 districts in Ethiopia have information on burden of disease. In each country, 20 health facility catchments are randomly selected using a random number generator. Of
1. Daily washing and drying of the limbs
2. Attending to entry lesions to prevent secondary bacterial infections
3. Daily elevation and simple exercises
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients lymphoedema, their carers and community health workers who: 1. Reside within a 10 km radius of the selected health facilities 2. Are 18 years of age or older 3. Patients must have moderate to severe leg lymphoedema as defined as stage 3 or above according to the Dreyer staging system for filarial lymphoedema 4. Patients must be able to perform the daily self-care protocol either independently or with the aid of a carer. 5. Carers must be available on a daily basis to assist the patient with lymphoedema-care activities as needed 6. All participants must be able to provide informed consent
Exclusion criteria
Exclusion criteria: Patients lymphoedema, their carers and community health workers who: 1. Are under 18 years of age 2. Decline to be involved in the study 3. Are unable to give informed consent 4. Are too unwell to participate 5. Lymphoedema patients who have mild leg lymphoedema as defined as stage 2 or below according to the Dreyer staging system for filarial lymphoedema 6. Patients with any medical condition eg heart, kidney, lung disease 7. Patients with severe arthritis 8. Patients with traumatic injury or surgery on the lymphoedema limb 9. Patients or carers who are unable or unwilling to perform daily lymphoedema-care activities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphoedema status is measured at baseline prior to participants receiving the training in lymphoedema care, and after 4, 12 and 24 weeks of performing the daily protocol using: 1. Lymphoedema stage according to the Dreyer 7 stage system 2. Limb circumference at mid-calf using a tape measure 3. Subcutaneous tissue compressibility at mid-calf using an indurometer (the Indurometer is a small hand held device which non-invasively measures the degree of tissue compressibility in the skin and subcutaneous compartment. This device is previously validated in women with breast cancer-related arm lymphoedema and young, asymptomatic people residing in an LF endemic region in Myanmar) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherence to the self-care protocol measured at baseline prior to participants receiving the training in lymphoedema care, and after 4, 12 and 24 weeks of performing the daily protocol using: 1.1. Daily journal kept by the participant and collected at each follow-up measure 1.2. Knowledge, attitudes and practices (KAP) questionnaire administered at baseline and after 24 weeks 2. Self-reported symptoms measured at baseline prior to participants receiving the training in lymphoedema care, and after 4, 12 and 24 weeks of performing the daily protocol using: 2.1. Pain 2.2. Perceived level of functional disability 2.3. Frequency and duration of acute attacks (secondary bacterial infections) 2.4. Days of work lost due to the disease 3. Quality of life measured using visual analogue scale at baseline prior to participants receiving the training in lymphoedema care, and after 4, 12 and 24 weeks of performing the daily protocol | — |
Countries
Bangladesh, Ethiopia
Outcome results
None listed