Sunday, March 05, 2006

Comprehensive Lymphedema Managment: Results of a 5-year follow-up.

Bonnie B. Lasinski, MA, PT, CLT-LANA and Marvin Boris, MDPresented at the 18th Congress of the International Society of LymphologyGenoa, Italy, September 2001Published in Lymphology 35 (Suppl):301-304, 2002

It is well known that lymphedema, untreated, is a progressive, chronic, incurable disease. While the incidence of lymphedema secondary to treatment for breast cancer is reported to average between 6-30% , the incidence of lymphedema secondary to other cancer surgeries and treatments has not been well reported. In addition, primary lymphedema (other than connatal which appears at birth) which develops in childhood, adolescence, or later life, is often misdiagnosed and under-treated. Lacking accurate information about which individuals are at risk prevents proper screening and education in lymphedema risk management strategies. Early diagnosis and intervention can minimize the lymphedema progression from Stage 1, which is easily reversible, into Stage 2 and Stage 3.

Experts in the field of lymphology generally agree that the initial treatment for lymphedema should be Complete Decongestive Therapy (CDT)/Complex Lymphedema Therapy (CLT). Complete Decongestive Therapy (CDT)/Complex Lymphedema Therapy (CLT) is a two-phase program. The first phase consists of meticulous skin care and treatment of any fungal infections/ulceration of the skin, manual lymphatic drainage, exercises that mimic the pattern of lymphatic drainage appropriate for the individual patient, and compression with multi-layered, short-stretch bandages. Phase 2 focuses on conserving and optimizing the reduction in lymphedema achieved in phase 1. This is accomplished by patient compliance with a self-care program.

This program consists of the skin care regime adopted for that individual during Phase 1 and attention to risk reduction strategies for the involved limb(s). In addition, compression of the affected areas is achieved by means of low-stretch elastic compression stockings or sleeves (supplemented with nightly compression bandaging instead of stockings/sleeves if needed. Individuals must perform their lymphedema exercise/self-lymphatic drainage program twice daily for optimal results.

The importance of regular follow-up visits for evaluation of the affected areas including girth/volume measurements, review/modification of self-care program, and fitting/modifying compression stockings/sleeves cannot be underestimated. Individuals with lymphedema, like diabetes or any other chronic medical condition, deserve to have the appropriate skilled medical and psychological support provided to achieve continued success with their Phase 2 program. Additional intensive CDT/CLT treatment should not be routinely necessary. However, there are situations that exacerbate lymphedema (such as trauma, infection, surgery on or adjacent to, the involved areas. Additional treatment may be warranted if the individual is unable to reduce the exacerbation independently by following their Phase 2 program, supplemented by self-bandaging daily for a short period of time.

Complex Lymphedema Therapy, as practiced today in the US, was principally introduced, applied, and refined in Germany by the Foldis in the 1980's . This technique, also called Combined Decongestive Physiotherapy (CDP) was modified and supplemented with specific physical therapy exercises by the Casley-Smiths in Australia. They called the technique Complex Physical Therapy (CPT) . Several other authors have reported varying results of CDT with average lymphedema reductions ranging from 15% to 68.6%

Critics of CDT question whether individuals can continue to maintain their reductions with compliance with their Phase 2 home program without additional intensive Phase 1 type treatment. The goal of this study is to demonstrate that the excellent reductions in lymphedema and fibrosclerotic changes achieved through a single course of CDT/CLT can be maintained over a 5 year period without further intensive treatment, provided that the individual's medical condition remains stable.

PATIENTS AND METHOD

SStudy PopulationOur group examined the initial and follow-up results of 146 consecutive patients with unilateral extremity lymphedema who were treated with a single course of CLT/CDT at the Lymphedema Therapy facility in Woodbury, New York, USA from 1992 to 2000. The number of treatments ranged from 10-34 with the average being 18.7. The demographic and disease characteristics of the study group are summarized in Table 1.

Table 1 - Demographic and Disease Characteristics of Study Subjects

Patients With One Affected Arm (N=112)

Age (years)
Mean 56.7 (+/- 11.8)
Range 32-82

Gender Female 110
Male 2

Type of lymphedema Primary 1 Secondary 111

Stage of lymphedema

Stage 1 -21
Stage 2 - 90
Stage 3 - 1

Arm affected

Right 48
Left 64

Patients With One Affected Leg (N=34)

Age (years)
Mean 58.2 (+/- 16)
Range 33-85

GenderFemale 19
Male 15

Type of lymphedema

Primary 13
Secondary 21

Stage of lymphedema

Stage 1 - 3

Stage 2 - 29

Stage 3 - 2

Leg affected

Right 15
Left 19

Mean (+/- SD) duration of lymphedema Mean (+/- SD) duration of lymphedema
3.4 (+/- 6.1) years Range- 3 wks-31 years 11 (+/- 12.9) years Range - 4 wks - 42 years

Lymphedema was classified according to the criteria accepted by the International Society of Lymphology . Stage 1 lymphedema is defined as lymphedema that pits on pressure and is reversible upon elevation of the affected area. Stage 2 lymphedema is defined as edema that is irreversible, difficult to pit or is completely non-pitting. As it progresses, there may be subcutaneous tissue fibrosis and skin alterations. Stage 3, lymphostatic elephantiasis, is defined clinically by severe fibrosclerotic tissue changes with skin alterations that may include papular lesions, warty changes, the development of lymphoceles, skin flaps/bulges, the presence of chronic fungal and bacterial infections, and lymphorrhea.

Clinical Analysis

To determine the volume of lymphedema in each limb, circumferences were measured at 10-cm intervals with a flexible tape. Volume was calculated for each 10-cm segment by utilizing the formula for a truncated cone: Volume = H(Ct2 + Ct x Cb + Cb2) / 12p .

Treatment

Patients received a single course of CLT/CDT which is described in detail in reference numbers 11,14,16.Each treatment session lasts approximately 2 hours per day and is administered 5 days per week for an average of 18.7 sessions, with a range of 10-34 treatments. All of the procedures are performed by a licensed physical therapist/physical therapist assistant who has undergone specific training at our center with a certified Casley-Smith School instructor.

Upon completion of CLT, patients are fitted with compression garments, ranging in pressure from 20-60mm HG, depending upon the limb /limbs involved, severity of the lymphedema, and other individual medical and social factors. The home-maintenance program following CLT consists of 24-hour compression garment wear and a patient- specific physical therapy exercise program to be performed twice daily at home for 15 to 20 minutes.

Statistical Methods

All available patients (over the age of 18) were included in the study, excluding 17 individuals who had to undergo additional treatment at some point after their initial 15-20 day course. Patients with bilateral upper or lower extremity lymphedema were excluded from this report.

A mixed models repeated measures analysis of covariance (RMANCOVA) was used to analyze the data for each group separately. The within-groups factor was the time since the initial course of therapy. The between-groups factor was the degree of compliance (compliance with exercises and the use of compression garments averaged together).


For the purpose of this analysis, compliance at the initial visit was set at 100%. All assumptions were examined for each model and appeared to have been met. None of the demographic and disease characteristics (age, gender, and type of lymphedema, lymphedema grade, and duration of lymphedema) differed significantly between the compliant and non-compliant patients.

In this study, compliance was evaluated by the percentage of time the patients wore a compression garment and their adherence to special physical therapy exercises, which included some self-lymphatic drainage, built into the program. Compliance was analyzed at each follow-up visit. No additional courses of CLT/CDT were administered to the study group.


Forty-four individuals were eliminated from this study because they had expired and seventeen had moved away from the area.


RESULTS

All 146 patients who received a single course of CLT/CDT for the lymphedema in one arm or one lower limb were analyzed separately. Lymphedema reductions after CLT/CDT averaged 67.7% in the 112 individuals with one affected arm, and 71.6% in the 34 individuals with one affected leg. At 5-year follow-up, the average reduction in individuals with one affected arm increased to 75%, and decreased to 62% in those with one affected leg.

Lymphedema Therapy

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