Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema

NCT ID: NCT02165696

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

Brief Summary

Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.

Detailed Description

This study has two sub research: a quantitative approach and a qualitative approach. The research will be carried out by a multicenter way

Quantitative approach consist in carried out a single-blind randomized controlled trial of 44 women with arm lymphedema. Patients will be distributed in two intervention groups by a randomized way. Participants will be given his assignment by closed envelope. Both treatments will be administered five days a week for six weeks. The experimental group (n=22) will receive multimodal treatment: combination of manual lymphatic drainage and compression bandaging. The control group (n=22) only will receive manual lymphatic drainage. We want to determinate the effect on volume arm decrease, quality of life, level of hand strength, degree of pain, fatigue level, and state of anxiety and depression. The influence on the lymphedema will be analyzed with lower limbs strength, physical activity, lung function, respiratory muscle strength by maximal inspiratory and expiratory pressure measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence will be analyzed by a smartphone.

Qualitative apprach: to know the perceptions and experiences of the participants in both interventions groups through a qualitative descriptive study. Data will be obtained with semi-structured depth interview.

Conditions

Arm Lymphedema After Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual lymphatic drainage and compression bandaging

Experimental group: 30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week

Group Type: EXPERIMENTAL

Multimodal treatment: compression bandaging and manual lymph drainage.

Intervention Type: OTHER

30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week

Manual lymphatic drainage

Control group: 30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

Group Type: ACTIVE_COMPARATOR

Manual lymph drainage

Intervention Type: OTHER

30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

Interventions

Multimodal treatment: compression bandaging and manual lymph drainage.

30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week

Intervention Type: OTHER

Manual lymph drainage

30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

Intervention Type: OTHER

Other Intervention Names

Multimodal treatment

Eligibility Criteria

Inclusion Criteria

• Women between 45 and 65 years with secondary lymphedema in upper limb after breast cancer surgery.
• Cancer stages I-III according to TNM classification of the American Joint Committee on Cancer.

Exclusion Criteria

• To have received lymphedema treatment previously.
• To be treated by radiation therapy or chemotherapy.
• Distant metastases or local recurrence of cancer.
• Infectious signs in the upper limb with lymphedema.
• Uncontrolled hypertension.
• Heart disease.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Rocío Martín Valero

Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Málaga

Málaga, Málaga, Spain

Countries

Spain

Central Contacts

Martín-Valero R., Ph D

Role: CONTACT

rovalemas@gmail.com

34 657834413

Other Identifiers

Lymphatic Multimodal Treatment

Identifier Type: -

Identifier Source: secondary_id

UMA_CBM_2014/LYMP

Identifier Type: -

Identifier Source: org_study_id