Evaluation of Pressure Applying Efficiency in Multi-Layer Bandaging

NCT ID: NCT02857621

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-04-23

Brief Summary

Lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid in interstitial spaces. It is a progressive chronic disease and without appropriate management may result in serious complications. In Israel, patients are referred to physiotherapists certified in treatment for lymphedema. According to the International Society of Lymphology (ISL) the best treatment is a holistic, multidiscipline approach. Amongst the different methods of lymphedema management, the use of compression is the only treatment that has shown to be effective in randomized controlled trials.

The ISL recommends that patients with lymphedema in the lower limb ought to bandage their leg with multi-layer bandaging on a daily basis for a period of two to four weeks. A new classification system for compression bandages was recommended; pressure of <20 mmHg was categorized as mild, 20-40 mmHg as medium, 40-60 mmHg as strong and ≥60 mmHg as very strong. In patients with leg edema, bandages with strong pressure were shown to be the most effective. However, in the presence of a venous ulcer on a lymphatic leg, pressure between 35 and 45 mmHg is the widely accepted range for sufficient and safe compression. The use of measurement instruments is currently the only realistic method for determining the actual pressure achieved beneath the bandage. However, it is neither economical nor feasib¬le nor is it realistic in terms of time.

Recent studies show that many healthcare professionals use inadequate sub-bandage pressure. No study so far has focused on therapists that are trained in lymphatic treatment. In spite of correct pressure bandaging importance, the question whether physiotherapists succeed in correctly applying it is left unanswered. The main purpose of this study is to evaluate the pressure applying efficiency in multi-layer bandaging among physiotherapists in Israel who treat lymphedema.

34 physiotherapists trained in lymphatic treatment will be recruited for this research. Each volunteer will receive a questionnaire concerning their self-perceived competence in the application of compression bandages. Afterwards, two practical trials will be held a week apart in which the subjects will be asked to apply bandages using strong and medium pressure. Using PicoPress®, pressure will be measured directly after bandaging and two hours later. Our hypothesis is that the majority of therapists will properly apply medium or strong pressure on the lower limbs.

Conditions

Lymphedema

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Physical Therapists trained in Lymphatic treatments

Exclusion Criteria

• Have not treated a Lymphatic patient in the past two years

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: collaborator

Assuta Hospital Systems

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Woldman Anat, BPT

Role: STUDY_DIRECTOR

Physical Therapist at Maccabi HMO

Locations

Maccabi Healthcare Services

Bat Yam, , Israel

Countries

Israel

Other Identifiers

2016032

Identifier Type: -

Identifier Source: org_study_id