Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema

NCT02165696 | Unknown DMC

• 2 other identifiers: UMA_CBM_2014/LYMPLymphatic Multimodal Treatment
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Arm Lymphedema After Breast Cancer

Keywords

compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.

Outcome Measures

Primary Outcomes (1)

• Perimetry

  Arm volume is measured with perimetry through truncation of cones formula

  Baseline, 6 weeks and 12 weeks

Secondary Outcomes (14)

• Handgrip strength

  Baseline, 6 weeks and 12 weeks

• Multiple sit-to-stant test

  Baseline, 6 weeks and 12 weeks

• Degree of pain

  Baseline, 6 weeks and 12 weeks

• Pulmonary function test

  Baseline, 6 weeks and 12 weeks

• Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)

  Baseline, 6 weeks and 12 weeks

Study Arms (2)

Manual lymphatic drainage and compression bandaging

EXPERIMENTAL

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

Other: Multimodal treatment: compression bandaging and manual lymph drainage.

Manual lymphatic drainage

ACTIVE COMPARATOR

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.

Other: Manual lymph drainage

Interventions

Multimodal treatment: compression bandaging and manual lymph drainage. 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

Also known as: Multimodal treatment

Manual lymphatic drainage and compression bandaging

Manual lymph drainage 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.

Manual lymphatic drainage

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

University of Málaga

Málaga, Málaga, Spain

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Manual Lymphatic Drainage; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Martín-Valero R., Ph D

CONTACT

34 657834413; rovalemas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

ES (1)