Physical Therapist Management of Lymphedema Following Treatment ...

Physical Therapist Management of Lymphedema Following Treatment for Breast Cancer: A Critical Review of Its Effectiveness The purpose of this review is to analyze the research literature that has examined the effectiveness of physical therapy in the management of lymphedema following treatment for breast cancer. Thirteen studies met the criteria for experimental research, which were then categorized according to Sackett's levels of evidence. One study was graded at level 11, 5 studies were graded at level 111, and the remaining 7 studies were graded at level V. One grade B recommendation and 6 grade C recommendations were developed from the levels of evidence. The 13 selected studies were also graded according to 6 criteria to evaluate scientific rigor. Clinical recommendations and future research directions are provided. [Megens A, Harris SR. Physical therapist management of lymphedema following treatment for breast cancer: a critical review of its effectiveness. Phys Ther. 1998;78:1302-1311.1

Key Words: Breast cancer, Lymphedema, Physical therapy.

Antoinette M e g m Susan R Harris Physical Therapy . Volume 78 . Number 12 . December 1998

Physical therapists ne out of every 8 women in the United States is expected to develop breast cancer,' and approximately 15% to 20% of the women who have axillary lymph nodes removed in the treatment for breast cancer will develop lymphed.~ is ema in the ipsilateral upper e ~ t r e m i t yLymphedema a condition in which there is an accumulation of proteins in the affected tissues, causing edema and inflammation within an e ~ t r e m i t y .Primary ~ lymphedema results from congenital defects in the lymphatic system. Secondary lymphedema is acquired due to obstruction or interruption of the lymphatic flow at the site of the lymph nodes.4 In women with breast cancer, lymphedema may arise due to damaged lymphatic vessels and obstruction in lymphatic flow caused by axillary node dissection surgery or radiation therapy.j Lymphedema can lead to a feeling of heaviness and discomfort in the involved upper extremity, impairments in function, and unsatisfactory a p p e a r a n ~ e .Large ~ amounts; of fluid in an extremity may cause restrictions in range of motion. Chronic lymphedema can compromise the! health of subcutaneous tissues, increasing the risk of developing infection. Lymphangiosarcoma, although rare, is an extremely malignant condition that has been associated with chronic l ~ m p h e d e m a Delay.~ ing inte:rvention to reduce lymphedema may result in poor functional outcomes, as well as increasing emotional distress.

can offer

People with lymphedema can be treated with interventions for medications or surgery, lymphedema that but these treatments have been largely unsucare less invasive cessful.Vhysica1 therapists, however, can offer than medications or less invasive treatments for lymphedema. Alsurgery. though a cure is not yet available, conservative treatmerit aims to reduce and control the amount of swelling in an affected limb, as well as to restore the function and cosmesis. Physical therapy interventions for lymphedema have included the use of elastic compression garments; the use of compression pumps; upper-extremity elevation; massage; active, isometric, and resistance exercises7;and ultra~ound.~ Compression garments may be prefabricated or custommade and are of varying degrees of elasticity. They presumably act to lessen the amount of excess fluid that can enter an affected extremity by increasing interstitial hydrostatic pressure within the limb. External compression by pneumatic pump can be either single chamber or multichamber. Multiple-chamber pumps are sequential in nature, and chambers inflate beginning distally, then inflate proximally. This action serves to move the

A Megens, PT, is a student i n t h e Master o f Science i n Rehabilitation Sciences Program, School o f Rehabilitarion Sciences, University o f R~itiah Columbia, Vancouver, British Columbia, Canada, V 6 T 2B5, and Clinician, British Columbia's Children's Hospital, V a n c o u v e r , British (:olumhld, Canada. S R Harris, PhD, PT, FAPTA, is Professor, School o f Rehabilitation Sciences, Lrniversity of British Columbia, T32.5-2211 U'eshrook Mall, Vaiicouver, British Columbia, Canada, V 6 T 2B5 ([email protected]). Address all col-respondence t o Dr Harris. T h i s work was supported, i n part, b y a research grant t o Dr Harris f r o m t h e Canadian Breast Cancer Foundation. Thzs ari~clezons rubtnztted Januaq 7, 1998, and was accepted Julq 7, 1998

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fluid proximally and out of the affected limb.4 Elevation reduces intravascular hydrostatic pressure, thus reducing formation of edema. Manual lymph drainage and the Foldi massage technique9 are used to stimulate residual lymphatic vessels to carry excess fluid from the affected extremity. "Complex physical therapy" (CPT) incorporates the Foldi massage technique but also includes exercises, compression garments, and skin hygiene in an attempt to maintain the reduction in limb size gained by the massage technique.lO,ll Exercise is thought to be beneficial due to skeletal muscle activity aiding the extrinsic pumping mechanism of the lymphatic system. Ultrasound and microwave treatments heat the limb tissues; it is hypothesized that the heated tissues improve lymphatic circulation and thus restore lymphatic f l o ~ . ~ ~ l 2 Studies using modalities that generate heat, such as ultrasounds and microwave,12 were conducted in Italy and China, respectively. North American experts in physical medicine and rehabilitation have long advised that any modality that generates heat (eg, shortwave diathermy, microwave diathermy, superficial heat) should be used with caution in people with active cancer due to the possibility of increasing tumor growth and metastasis.'" recent, well-controlled, randomized trial involving mice that had received subcutaneous injections of tumor cells demonstrated that therapeutic ultrasound enhanced tumor growth, although it did not enhance metastasis.14 Because it is often not known whether breast cancer is truly in remission, the possibility of a recurrence (ie, active cancer) should always be considered. There have been numerous descriptive reports and literature reviews regarding conservative treatments for people with lymphedema. Due to the many different treatment options available to practitioners, a diversity of management approaches in various care centers has resulted. The purpose of this review is not only to explore the existing research literature on the management of lymphedema following treatment for breast cancer, but to classify the literature in order to determine the strength of the available evidence. Sackett's rules of evidence15 categorize studies according to the strength of the research design and the amount of control for possible threats to internal validity. Based on 5 hierarchical levels of evidence (I-V), 3 grades of recommendation (A, B, and C) were created to guide practitioners in treatment options.15 Sackett's15 levels have previously been used to evaluate the literature regarding the physical therapist management of children with cerebral palsy,l6 physical therapy intervention for the management of children with cystic fibrosis," and the efficacy of adaptive seating for chil-

1304 . Megens and Harris

dren with cerebral palsy.ls The purpose of this review is to critically analyze the recent research involving physical therapist management of lymphedema secondary to breast cancer treatments. Sackett's rules of evidence were incorporated to develop evidence-based recommendations for physical therapist management of this condition.

Method Because we are fluent in English only, the literature search was restricted to English publications from 1966 through 1997. Index Medicus, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Health Planning and Administration/Health Services, Technology, Administration, and Research (HEALTHSTAR) were searched using the text words "lymphedema," "physical therapy," and "occupational therapy" and specific modality names such as "compression garments," "pneumatic pump," "elevation," and "ultrasound." Reference lists from previously identified research articles were also scanned to locate additional references. Study Selection Criteria

Studies were required to meet the following 4 criteria before they were included in our review: (1) all subjects had been treated for breast cancer, (2) subjects had secondary lymphedema in at least one upper extremity, (3) consewative or noninvasive treatment for lymphedema was the independent variable, (4) the size of the extremity being treated was a dependent variable. Review Criteria

Studies were evaluated according to Sackett's rules of evidence.15 Sackett's 5 hierarchical levels of evidence are as follows: (1) level I-large randomized controlled trial with low false-positive or false-negative errors (high power), (2) level 11-small randomized controlled trial with high false-positive or false-negative errors, (3) level 111-nonrandomized, concurrent cohort comparisons between contemporaneous subjects who did and did not receive the intervention, (4) level IV-nonrandomized, historical cohort comparisons between current subjects who received the intervention and former subjects who did not receive the intervention, and (5) level V-case series without controls. In level V studies, the clinical outcome of a group of subjects is described, but no control group or condition is included and thus no control of extraneous variables is undertaken. A case study on a single individual cannot be included in this category. Considering the potential echical conflicts of having a pure control group for the conditions being studied, Sackett's levels I through IV were modified. Studies in which 2 or more treatments were compared, as opposed


to only those in which there was a control group that received no treatment, were also considered appropriate for inclusion in levels I through IV. This method was also suggested in the critical reviews by Piper16 and Boyd and colleagues.l 7 Sackett]!' also outlined 3 grades of recommendations, based or1 the levels of evidence. Grade A recommendations are supported by at least one, but preferably more, level I study. Grade B recommendations are made for outcomtts supported by at least one level I1 study. Grade C recorrlmendations are supported by level 111, IV,or V studies. In order to evaluate the methodological rigor of the studies, the following criteria were adapted from Sackett'slq r~rlesfor scientific evidence and Harris'20criteria for evaluating scientific merit: (1) inclusion and exclusion criteria were listed for the subjects and included an opt:rational definition of lymphedema, (2) the treatment protocol was adequately described to be replicable, (3) the reliability of data obtained with outcome measures was investigated, (4) the validity of the outcome measures has been assessed, (5) the assessors were blirlded to the treatment groups, and (6) all subjects enrolled in the study were accounted for.

Results Initially, 42 articles were identified that referred to treatment for lyrnphedema. Many of these articles were reviews or descriptive reports. There were 19 articles that reported experimental or quasi-experimental studi e ~ . ~ , ~ , l ~ -To l ~assess , f l - ~the reliability of different raters' judgments in classifying these studies according to Sackett's rules, we independently reviewed and classified them. Interrater agreement on level of evidence was attdined for 15 of the 19 studies (78.9%).We discussed the 4 studies on which there was disagreement in determining the Sackett level, and we arrived at a corlsensus decision for each of the 4 studies. Thirteen7.8.10-12r21-28 of the 19 experimental studies also met the 4 study selection criteria. The 6 experimental studies that were excluded were those that involved subjects who had developed lymphedema from causes other than treatments for breast cancer and thus did not satis@all of the study selection criteria.

Scientific Rigor of the Studies

The scientific rigor of the studies was evaluated by the 6 criteria outlined earlier. These evaluative criteria for each study are summarized in Table 2. Subject inclusion and exclusion criteria. Inclusion and exclusion criteria were similar in most studies. In order to qualify for the review, each article chosen included subjects who had been treated for breast cancer and who had developed lymphedema following treatments. Inclusion criteria required that there be no evidence of active disease or metastases in the subjects. For all of the studies, the inclusion criteria required subjects to have some degree of lymphedema. In only 9 of the studhowever, were there operational definitions of lymphedema. Within these 9 studies, there were 5 different definitions for lyrnphedema. Three studieslO-l2based inclusion criteria on the International definition, which provides a Society of Lymph~logy'~ description of various levels of lymphedema but no measurable size differences. Reliability has not been investigated for the use of this scale. In 2 of the studies,21,22 subjects had to have a cumulative circumferential difference between the 2 upper extremities of greater ~ ~involved ,~~ than 10 cm across 7 sites. In 2 s t ~ d i e s ,the upper extremity had to have 110% of the volume of the uninvolved upper extremity. For 1 study,8 the researchers required the circumference of the involved extremity to be more than 6.5% larger than that of the uninvolved extremity. In another study,25a volume difference of 150 mL was required between the 2 extremities. One group of researchers24 used self-selected subjects who had requested treatment for lymphedema. These researchersZ4and the researchers in the remaining 3 s t ~ d i e s ~ . 2 ~ . 2 ~ provided no operational definition for what constituted lymphedema. Repeatability of the treatment protocol. When specific modalities (eg, ultrasound, pneumatic pressure therapy) were included in an investigation, all but one study7 provided sufficient detail to allow repetition of the intervention protocol. Researchers using CPTIOJ1 did not describe the actual exercises, thus preventing replication of the treatment.

Outcome measure reliability. Reliability of data obtained with the outcome measure was described in 4 of the studies. Swedborg7 studied the intrarater reliability of measurements obtained by water displacement Levels of Evidence volumetry over 3 consecutive days in women without The levels of evidence and other study characteristics are lymphedema and found that the greatest variation summarized in Table 1. Of the 13 studies evaluated observed was 1.2% of the total limb volume. Swedborg according to Sackett's levels, 1 study21 was identified as a and colleagues used the same technique in 3 later level I1 study, 5 st~dies~,l~,2~.~5.28 were categorized as level 111 studies, and the remaining 7 s t ~ d i e s ~ , l l , l 2 , 2 ~ , 2 ~ , 2st~dies.2~-2~ ~,2~ In the remaining 9 studies, there were no assessments of the reliability of data for the outcome were classified as level V studies. measures.

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Table 1. Levels of Evidence and Other Study Characteristicso

Author(s) Balzarini et al,a 1993

Experimental Design and Level of Evidence Subjects Pretest-posttest, nonrandom assignment to 1 of 2 comparison groups Level Ill

Bertelli et aI,21 1991

Small randomized controlled trial Level II

Bertelli et a1,22 1992

Pretest-posttest, nonrandom assignment to 1 of 3 comparison groups Level Ill

Bunce et al,23 1994

One group pretestposttest Level V

Gan et a1,12 1996


Kim-Sing and Basco,24 1987


Matthews and Smith,'O 1996

Pretest-posttestwith 2 comparison groups, nonrandom assignment Level Ill


Length of Study

Intervention

Outcome Measures

ResuIts

150 women 5 0 women received 12 mo posttreatment US, half wore CG, for breast half without; 100 cancer, women used PP, half consecutive with CG, half without persons with lymphedema (lymphedema not defined)

Circumference at Use of C G 5 sites, made no percentage difference; PP less well difference summed tolerated

7 4 subjects with Group A: C G unilateral Group B: mastectomy CG+electrical and stimulation device lymphedema; circumferential difference between UEs of 10-20 cm

Circumerential Both groups difference at 7 showed sites summed differences between T=O and T=6, but no difference between groups

120 women Group A: C G with unilateral (37 subjects) involvement Group B: CG+electrical treated for breast cancer, stimulation device with (37 subjects) circumferential Group C: CG+PP difference (46 subjects) between arms of 10-40 cm

Arm circumference at 7 sites, difference summed

25 women following treatment for breast cancer with lymphedema (not defined)

Foldi massage; sequential PP; compression bandage

12-mo followUP

All groups had decreased arm size posttreatment; no difference between groups

Circumference at 40% decrease in excess 4 points, calculated into volume; volume of a stable at 12 cylinder mo

45 subjects with Two courses of unilateral UE microwave heating, lymphedema C G during day (defined by International Society of Lymphology)

Water volumetry Decrease in Two courses and subjective pain and of treatment, report volume of 2 0 d each limb

15 women selfselected (requesting treatment for lymphedema)

48-h trial

Circumference at Decrease in one site on forearm forearm circumference of 0.5-5.5 cm

12 mo

Circumference at N o difference 1Ocm between intervals, subjects in results full CPT summed; program and percentage subjects in difference modified CPT between limbs program calculated

Subjects treated with Wright linear pump

2 4 women and 5 subjects received full 1 man with CPT, 2 0 subjects lymphedema, received modified (defined by CPT International Society of L~m~holog~)

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Table 1. Continued

Author(s)

Experimental Design and Level of Evidence Subjects

Morgan et al," 1992

One group pretestposttest

Intervention

7 8 consecutive CPT women who had 1. exercise 2. Foldi massage lymphedema (as defined by 3. CG International 4. skin hygiene Society of

Level V

Length of Outcome Study Measures 13 mo

Circumference Grade 1 of arm used lymphedema= 14% to calculate decrease volume by Grade 2 truncated lymphedema=30% cone method decrease; good

L~m~holog~) Swedborg,7 1977 One group pretestposttest

7 women with postsurgical treatment for breast cancer (no definition of lymphedema)

Level V

Swedborg,25 1980

Nonrandomized crossover design for six groups Level III

Swedborg,26 1984


Swedborg et al,27 Pretest-posttest, no 1993 control group

Zanolla et al,28 1984

Pretest-posttest with 3 comparison groups, nonrandom assignment Level Ill

results with lowelastic C G Not repeatable 7 d lymph pulsator

7d

Volumetry

Decrease of arm volume [X=2.3%)

Water 3%4% decrease in 3 9 women treated Protocols A, 0, and C Each for breast cancer with various treatment displacement arm volume in first combinations of 4 wk volume 4 d of treatment with surgery, 150-mL massage, exercise, long, 3 with protocols B difference and CG; each treatment and C subject received each protocols between UEs protocol for each subject with breaks between protocols 2 5 0 consecutive patients seen for breast cancer treatment, 54 patients chosen; 10% difference in size of UEs

1. control period 2. C G 3. intermittent PP 4. CG

6 mo

Arm volume

33 women with

Supine arm elevation

5 h

Volume Reduction in volume of 1%-3%; more measured by water reduction in control displacement arm than in limb with lymphedema after 1 h but not after 5 h

unilateral lymphedema due to treatment for breast cancer; 10% difference in UE volume

Level V

Results

60 women with lymphedema following treatment for breast cancer (lymphedema not defined)

Group 1: PP with 3 mo uniform pressure Group 2: PP with differentiated pressure Group 3: manual massage (all subjects wore CG)

Reduction of arm size with garment alone; further reduction with PP; loss of improvements with no C G

One site taken Group 1 : 1.5cm at the point reduction at one of maximum circumferential site arm Group 2: 0.3cm circumference reduction Group 3: 0.9cm reduction

t

"PP=pncumatic pump, CG=compres?ion garment, CPT=complex physical therapy, US=ultrasound, UE=upper extremity.

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Outcome measure validiiy. None of the studies included any indication of validity for any of the outcome measures used. Of the 13 studies reviewed, 8 different methods were used to measure the size of the upper extremities. Volume measurement by water displacement, a method used in 5 studie~,~,~2,2~-2~ is considered by many researchers to be the gold standard for estimating the volume of an irregular shape. In the remaining 8 studies, circumferential measurements were used. In 2 studies, circumferential measurements were used to calculate the volume of a cylinderz3 and the volume of a truncated cone.ll In 2 s t u d i e ~ , ~only ~ . 2 ~a single circumferential measurement was compared for the involved and uninvolved extremities. In 4 studies,s.10-~1~22 the circumferences at a number of different sites were measured and summed. Next, the values for the involved and uninvolved extremities were compared. The number and location of sites at which circumferential measurements were taken vary greatly from study to study.

All of these methods appear to have face validity for estimating change in the size of a limb with treatment. Vnhime calculation by the truncated cone method, which is the method of volume calculation used by Morgan et al,ll has been studied for the lower extremity36 and the upper extremity3' and has been shown to have good concurrent validity with water displacement volumetry ( r =.93 and .99, respectively). The concurrent validity of volume calculation by the cylinder method compared with water displacement has been investigated in the lower extremity ( ~ - = . 9 9but ) ~ ~not in the upper extremity. Concurrent validity of measurements obtained with the other methods of upper-extremity size estimation has not been investigated. Blind assessment. In none of the studies was the use of blinded outcome assessors explicitly described.

In 12 of the 13 studies reviewed, subject attrition was described and the reason for the subject attrition was given. In the study by Bunce and colleag~es,2~ one subject was not accounted for at the 1-year follow-up; no explanation was provided for the subject's absence.

Account for attrition.

Grades of Recommendation Following Sackett's rules for creating grades of recommendations from the levels of evidence, 7 recommendations were developed. One grade B recommendation is provided from the single level I1 study. Six grade C recommendations are suggested, incorporating results of the studit.s thvalu;ited to be at levels I11 through V.

Grade B recommendation arising from the level I1 study:


1. Compression garments appear to reduce limb size after 6 months of use. The addition of electrical stimulation does not improve the results.21 Grade C recommendations arising from level I11 to V evidence:

1. Elevation alone is not effective in controlling ly~nphedema.~~

2. Microwave treatment, in combination with compression garment use, has demonstrated promising results in the reduction of limb size.12

3. Compression garments alone reduce limb size. Pneumatic pumps or electrical stimulation devices, in combination with compression garments, do not improve the results.22 4. Complex physical therapy, which combines exercise, Foldi massage, use of compression garments, and skin hygiene, is supported by 2 level V studies,lO.ll although "modified CPT" was found to be just as effective as regular CPT.I0According to Matthews and Smith, the standard program of CPT requires "daily treatments of more than one hour in duration for a period of four week~,"l~(p"~) whereas their modified program of CPT required only twice-weekly treatments and used pressure garments rather than compression bandaging.

5. Combinations of treatments including massage, pneumatic pump, and compression garments show promising results in the treatment of people with lymphedema.Z3.Z5 6. The Wright linear pneumatic pump, a 3chamber, gradient pressure, sequential intermittent pump, is effective in reducing limb size,24as is the uniform pressure pneumatic p ~ m p , ~ % h e nfollowed by the use of compression garments.

Discussion By using Sackett's rules of evidence to evaluate research articles, some support for the use of various physical therapy interventions and techniques in the management of lymphedema, secondary to breast cancer treatments, ha$ been found. It is important to note, however, that only 1 of the 13 studies reviewed was a randomized controlled trial. This studyz1 was graded at level I1 because of the small sample size, creating low power to detect group differences. The remaining 12 studies were graded at level 111or V. This finding is not to suggest that the treatment approaches used in level 111 to V studies are less effective, but only that the research designs used to study them were less rigorous and thus there is


Table 2. Evaluative Criteria for Studies Reviewed

Author(s) Balzarini et a1,8 1993 Bertelli et a1,21 1991 Bertelli et a1,22 1992 Bunce ei a1,23 1994 Gan et al,'2 1996 Kim-Sing and 6 o s c 0 , ~1987 ~ Matihews and Smith,'o 1996 Morgan et a!," 1992 Swedborg,7 1977 Swedborg,25 1980 Swedborg,26 1984 Swedborg et aI,Z7 1993 Zanolla et a1,28 1984

Defined Lymphedema

Treatment Can Be Replicated

Reliability of Outcome Measures Was Assessed

Y

Y

N

N

N

Y

Y

Y

N

N

N

Y

Y

Y

N

N

N

Y

N Y

Y Y

N

N

N Y

N N

N Y

N

Y

N

N

N

Y

Y

N

N

N

N

Y

Y N

N N

N Y

Y Y

N

N

Y Y

Y

Y

Y

Y

N

Y

Y

Y

Y

Y

N

Y

Y

Y

Y

Y

N

Y

N

Y

N

N

N

Y

dinlinished confidence that the treatments themselves created the change in the outcome measure. The large number of grade C studies indicates the prevalence of less rigorous research in the management of this condition. Further studies with better control and more rigorous designs will clarify the value of the tentative grade C recommendations. Randomized controlled trials provide the best evidence for treatment efficacy.]Wontrolling extraneous variables and randomly assigning subjects to groups to maximize equality between the groups improve the strength of experimental design. By applying strict controls on the experiment, confidence in the findings may increase. The ability of the randomized controlled trial to capture the complexity of individuals or a unique clinical situation, however, may be o v e r e ~ t i m a t e d .True ~ ~ experiments are more controlled than typical clinical settings and situations, and results of these experiments may not apply in the clinical setting. Due to ethical considerations, a full randomized controlled trial is not always possible. Sackett's rules of evidence ensure that the most rigorous research designs are acknowledged as such, but thev also allow for other research designs to be recognized. By including obse~ationsthrough other less rigorous forms of research, potentially helpful treatment Physical Therapy . Volume 78 . Number 12 . December 1998

Validity of Outcome Measures Has Been Investigated

Blind Assessment of Outcome

Account for Attrition

protocols are recognized, with the intention of increasing benefits to patients.lWptimally, recommendations would be similar, regardless of the type of research design or level of evidence of the study. Numerous studies of varying research designs but with similar results would provide the most confidence in recommendations. The levels of evidence and scientific merit of a study must be considered together before making conclusions regarding the effectiveness of physical therapy i n t e ~ e n tion for the management of lymphedema. The 13 studies selected for review were analyzed for scientific rigor according to 6 criteria. None of the articles included in the review fulfilled all of the criteria for scientific rigor suggested in this article (see Tab. 2). One way to improve the believability of experimental findings is to include blinding in the assessment of outcomes. This blinding will prevent the researcher from incorporating expectations about the outcome while evaluating a s u b ject. In studies with more than one group, random allocation attempts to control extraneous factors in subject pools, balancing variables throughout the groups. Outcome measures allow for systematic documentation of the amount of change in the dependent variable in an Megens and Harris . 1309

experiment. In the 13 studies reviewed, 7 different methods were used to quantify the size of the limbs being treated. Investigation o r use of outcome measures that give valid and reliable data is a critical component of a strong study. In order for an outcome measure to yield valid data, it must first yield reliable data. Only one investigator in 4 separate s t ~ d i e s ~ t ~ demonstrated ~-27 the reliability of the data obtained with the outcome measure chosen. Five groups of investigators incorporated the gold standard outcome measure into their studies,7.E,25-27and one other group of investigatorsll used a preciously validated method for determining upperextremity volume. T h e remaining researchers did not demonstrate validity or reliability of the data for the outcome measures chosen, thus creating further cause for uncertainty in interpreting the results of these studies. The grade B and C recommendations developed from the levels of evidence should be considered tentatively. First, none of the recommendations were based on many conclusive studies. Instead, recommendations were based o n the results of 1 o r 2 level I1 to V studies. Second, from the 1.7 articles included in the review, 7 different methods were used to quantify the size of the limbs, which does not allow comparison among different treatment protocols. Lastly, only one of the investigators demonstrated the reliability of the data obtained with the outcome meastlre chosen, which is a necessary, but not sufficient, prerequisite for validity of the data for an outcome measure. Without assurance of outcome measures that yield valid and reliable data, it cannot be determined whether the treatment results are d u e to the treatment protocol or whether they are a result of measurement error. The combination of these factors causes concern when considering the recommendations based o n the available evidence in the conservative management of lymphedema following treatment for breast cancer. Clinical Recommendations

Despite the relatively limited scientific evidence in support of physical therapy interventions for the management of lymphedema following breast cancer treatment, the following clinical recommendations are suggested: Physical therapists should encourage consistent and long-term use of compression garments in patients with lymphedema. Whether these garments need to be custom-fitted sleeves o r standard-sized sleeves is not clear from the studies reviewed, nor is there consistency among the studies in the suggested amount of compression provided. A physical therapist with clinical expertise in the treatment of people with uppcr-extremity lymphedema has rec-

13 10 . Megens and Harris

ommended a range of 3 compression classes: 20 to SO mm Hg, 30 to 40 mm Hg, and 40 to 50 mm Hg.3g Combined techniques, involving massage, sequential pneumatic compression, compression garments o r compression bandaging, and exercise, may also be effective. It is not clear, however, whether such a combined program is actually more effective than a program involving pneumatic compression only followed by compression garments. Based on o n e study, modified CPT may be just as effective as standard CPT, and it is far less labor intensive and therefore less costly. Microwave therapy, used in conjunction with compression garments, may b e effective in reducing limb volume, but electrical stimulation, used in combination with compression garments, is no more effective than compression garments alone.

Summary Thirteen studies using physical therapy for the management of lymphedema following treatment for breast cancer were evaluated according to Sackett's 5 rules of ekldence. The 13 studies were also assessed to evaluate scientific rigor according to 6 criteria. O n e study was evaluated at level 11, 5 studies were evaluated at level 111, and the remaining 7 studies were evaluated at level V, generating 1 grade B recommendation a n d 6 grade C recommendations. Caution must be exercised when considering these recommendations because none of them are supported by numerous, definitive studies. More rigorous research, incorporating blind assessment of outcomes and random assignment of subjects to groups, will enhance clarification of these tentative recommendations. Consensus o n an outcome measure that yields valid and reliable data for the evaluation of limb size is critical to allow for comparison of results across studies. References 1 Cancm Facts and Fzgures 1998. Atlanta, Ga: American Cancer Society: 1998.

2 Markowski J , UTilcoxJP, Helm PA. Lymphedema incidence after specific postmastectomy therapy. Arch Phys Med Rehabil. 1981;62: 449 - 4.52. 3 Grabois M. Cited by: Brennan MJ, DePompolo RUT, Garden FH. Focused review: postmastectomy lymphedema. Arch Phys Med Rehabil. 1996;77(3 Suppl):S74-SRO. 4 Brennan MJ, DePompolo RW, Garden FH. Focused review: postmastectomy ly~nphedema. Arch Phys Med Rehabil. 1996;77(3 Suppl): S74-SRO.

5 Brennan MJ. Lymphedema follo\v~ngthe surgical treatment of breast cancrr: a review of pathophys~ology and treatment. J Pazn Symptom Manage. 1992;7:110-116.


Zealand

24 Kim-Sing C, Basco VE. Postn~astecto~ny Iyinphedenra trciited wit11 the Wright linear piunp. Gun, J Surg. 1987;30::3ti8-370.

7 S~vedbol-gI. Voluminonietric estimatioii of the degree of lyiiiphedema and its therapy by p n e ~ ~ m a tconipression. ic S(.and JRehaDil Mrd. 1977;9:131-135.

25 Swedborg I. Effectiveness of combi~ied~riethodsof physiotherapy for post-mastectomy lymphoederna. Srarzd J ReIzrrDil Xltzti. 1980;12: 77-85.

8 Bnlzarini A, Pirovano C, Diazzi C, et al. Ultraso~~ntl therapy of chronic arm lyniphedeina after surgical treatment of breast cancer. Lynlphologv, 1993;26:128-134.

26 Swedborg I. Effects of treatment with all elastic sleeve and iiiterniittent pneumatic compression in post-niastectomy patients t\lth lyn~phoedema of the arm. Scnnd J Rehabil Mpd. 1984:16:35-41.

9 Mason M The tleatment of lymphoederna by con~plexphysical therapy. Auslralzan Journal of Phyriolherapy. 1993;39:41-45.

27 S~vedborgI, Nor]-efBlk JR, Piller NB, A a r d C. Lymphoede~na post-mastectomy: Is elevation alone an effective treatment? Scnnd J Rthabil Mpd. 1993;25:79-82.

6 Ross C. Coniplex physical therapy: a treatment note. Joul-nal uf Phj~iolheruj~y. 1994;40:19-2 1.

1%~'

10 Matthews K, Smith J. Effectiveness of 1nodifit.d complex physical therapy fur lymphoedema trcatlilent. Australian Journnl ofPhysiotherapy. 1996:42:323-328. 11 Morgan RG, Casley-SmithJR, Mason MR, Chsley-SmitliJR. Complex physical therapv for the lymphoedematous arm. J Hand Surg [Br]. 1992;17:4:17-441.

28 Zanolla R, Monzeglio C, Ba1z;irilli A, Martino G. E\a111atio11of the results of three different methods uf pustlllastectolliy ly~r~plieden~a treatment. J .Surg Onrol. 1984;26:210-213. 29 Boris M, Weiiido~f S, Lasillski B. Pel-s~stenceof Iv~iipliedeina r e d ~ ~ c t i oafter n nonin\asive coliiplex lyniphedeina therapv. O n t u l o ~ (Hunlrngt). 1997;11:99-109.

12 (3an.1, Li S, Cai R, Chang T. Microwave heating in the n i a ~ ~ a g e i i ~ e n t 30 Casley-Smith JR. Casley-Smitli JR. Moderii treatnlent of lymphoof po5tniastectomy upper limb ly~npliedenia.Ann Plasl Sutg. 199ti;36: etlema, I: complex physical therapy-the fil.st 200 Australiaii limbs. 576-580. Austmlas J Do.,11alo1.1992;33:61-68. 13 1.ehmann JF, de Lateur BJ. Therapeutic heat. In: Lehmann JF, ed. 31 Kleiii MJ, Alexander MA. Wright JM, et al. Treatment of adult lower Therapr~li,~ Hpat and Cold. 4th ed. Baltimore, Md: Williams & M7ilkins; extremity lyniphedenia with the IVright liiiear puinp: statistical analysis 1990:417-581. of a clinical trial. Arch P11yy.rnlpd KrlruDil. lY88;69:202-PO~i. 14 Sicard-Rosenbaum L, Lord D, DanoffJV, et al. Effects of contimious therapeutic ultrasound on growth and metastasis of subcutaneous 32 Raines JK, O'Doriiiell '1.F Jr, Kalisl~erI., D a r l i ~ ~KC. g Selection of' ~ntn.inetumors. Phys Ther. 1995;75:3-11. p a t i e ~ ~with t s lyliiphede~~~a for conipression tl~erapy.AIILJ S I L I ; 11977: ~. 133:430-437. 15 Sackett DI,. Rules of evidence and clinical recommendations on the 33 Richmand Dhl, O'Doiinell TF ,Ti-, Zelikocski A. Srque~~tial pneuuse of antithrombotic agents. Cho~l.1989;95(2 Suppl):2%4S. matic compression for lympheden~a: a controlled 11-ial. Arch S q 16 I'iper hlC. Efficacy of physical therapy: rate of motor developnient 1985;120:1116-1119. Therapy. 11919O;'L: in children with cerebral palsy. Pediatric P/~~.riral 34 Ti-Sheng C. Well-Yi H, Lelulg-Y~~ H, Wo-I L. Heat and bandage 126-130. report of 1,045 treatment for chronic lyinphedema of extret~~ities: 17 Ibyd S, Brooks D, Agnew-(:oughlin J, Ashwell J. Evaluation of the cases. Thai,/oumul c ~ f Surgery. 1985;6:3-12. lite~atureon the effectiveness of physical therapy modalities in the mailagement of children witli cystic iil>rosis. Pediatric Physical Thriafiy. 35 Casley-SmithJR. (:ited b \ Casley-SiiiitliJR, Caslry-S~nitli JK. Modern 199.$;6:70--74. treatnient of lyinpl~oeden~a, I: coiiiplex pl~ysicaltliei-apy-the first 'LOO r2ustraliaii limbs. Au~tiolasJDetn~trtul.19Y1:33:61-68. 18 Roxborough I.. Review of the efficacy and effectiveness of adaptive seating for children witli cerehul palsy. A.s.si.\tive Technology. 1995;7: 36 Kaulesar Sukul DMKS, den Hoed PT,,JoliaiiiiesEJ, et al. Direct and indirect methods for the quaiiiificatio~~ of leg volun~e:coinparison 17-5. between water displacement volu~iiet~y, the disk moclcl iiietliod, and 19 1)epartlnent of Clinical Epidemiology and Biostatistics, McMaster the Frustru~nsign niodel ~tiethod,usiiig the curl-elatio~~ coefficient and University. How to read clinical journals, V: to distinguish iisef~~l from the limits of agreement. J Bionlrd t.,'ng. 1993:15:477-480. useless and even harn~ful therapy. Can Mu1 Assoc J. 1981;124: 115ti-116:!. 37 Lirges JR, Mark BE, Stikele'ither SJ, W'or~.ellTW.Assessing the relationship between water displacement a ~ ~cii-cuiiiferential cl nlrasurr20 [Iarris SR. How should treatments be critiqiied for scientific inerit? lnellts in determining upper extren~i~y volui~ie in womcn with Phy.5 ?'her. 1996:76:175-181. . 10. Abstract. lyinphedema. Plzjs T h ~ r 11997:77;S109-S1 21 Bertelli G, L'enturini M, Forno (;, et al. Coiiservative treatment of 38 Doinholdt E. Physical ?'her/ifv KPsralch: Pri1~1.1j11i.s ccncl .-l/~filica/ions. postmastectomy Iymphedema: a controllerl, randomized trial. Ann Philadelphia, Pa: WB Sauntlers Co; 119193:153-161. Oncol. 1991;2:375-578. 39 Mark BE. Introduction tv evaluation a i d treatlrlrnt of lymphe22 Bertelli C, Venturini M, Forno C , et al. An analysis of prognostic dema. Unpublished handout at: An~ericanPhysical Therapy Associafactors in response to conselvative treatliient of postmastectoiny tion Con~hinedSections Meetiiig; F e b r u ; i ~18, 1996; Atlanta, C;i. lyml>l~ede~na. Surg Gynecol Ol~stet.1992;179:455-460. 23 Bunce IH, Mirolo BR, Hennessy JM, et al. Post-mastectotny lymplioede~iiatreatment arid measurement. MpdJAust. 1994;161:125-128.


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