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How effective are physiotherapy techniques to treat established secondary lymphoedema following surgery for cancer? A critical analysis of the literature.

ABSTRACT

This review examines the use and effectiveness of individual and combined physiotherapy techniques to treat established secondary lymphoedema. Secondary upper limb lymphoedema from axillary lymph node dissection is a debilitating potential sequela of surgery for breast cancer. Lymphoedema causes swelling of the affected limb(s) and affects the physical and psychosocial wellbeing of the patient. Physiotherapeutic techniques have been used to treat lymphoedema with some success, but the optimal interventions and regime remain unclear. Evidence supports the use of the Complex Physical Therapy (CPT) approach to treatment, but there is disagreement about the best prescription for treatment and the relative contribution of each technique to limb volume reduction. While ethical considerations regarding withholding of treatment discourage use of randomised controlled trials to evaluate CPT, further research is necessary to investigate the effectiveness of CPT on physical and psychological parameters. McCallin M, Johnston J, Bassett S (2005). How effective are physiotherapy techniques to treat established secondary lymphoedema following surgery for cancer? A critical analysis of the literature. New Zealand Journal of Physiotherapy 33(3) 101-112.

Key words: Lymphoedema, complex physical therapy.

INTRODUCTION

Lymphoedema is a high protein oedema caused by a low output abnormality of the lymphatic system (Mason, 2001). The reduced capacity of the lymphatic system causes fluid to build up under the skin, which results in swelling, discomfort and loss of function (Badger, Seers, Preston, & Mortimer, 2004). Lymphoedema may be primary or secondary. Primary lymphoedema results from a congenital abnormality of the lymphatic system. Secondary lymphoedema may be caused by trauma, such as axillary lymph node dissection during surgery for breast cancer, or by filariasis, which is a parasitic infection of the lymphatic system occurring in the South Pacific (Casley-Smith & Casley-Smith, 1992b). Physiotherapeutic techniques, including lymphatic massage and exercises, play a role in the physical treatment of lymphoedema. Additionally, physiotherapists may provide information and education to patients with this condition. The purpose of this review is to examine the effectiveness of physiotherapy treatment, and especially Complex Physical Therapy (CPT), for secondary lymphoedema caused by surgery to treat cancer.

Reports of the incidence of secondary lymphoedema vary widely. Some authors report an incidence of 25% in patients who had axillary lymph node removal, rising to 38% if surgery is combined with radiotherapy (Rampaul, Mullinger, Macmillan, Cid, Holmes, Morgan et al., 2003). Other estimates suggest an occurrence ranging from 6.7% to 62% in patients with breast cancer (Tobin, Lacey, Meyer, & Mortimer, 1993; Harris, Hugi, Olivotto & Levine, 2001), and between 6-30% in other reviews (Petrek & Heelan, 1998; Pain, Vowler, & Purushotham, 2003). Petrek and Heelan (1998) noted that studies with short follow-up periods reported a lower incidence of lymphoedema, indicating that the condition may develop over time, if it does at all. For instance, in New Zealand, a survey of 181 Otago women found that 38% had swelling at some time yet only 31% developed secondary lymphoedema (Clark, Wasilewska, & Carter, 1997). It seems that if patients are educated about prevention strategies, lymphoedema occurs only in 10% of patients, while the incidence rises to 30% in patients who have no education at all (Box, Reul-Hirche, Bullock-Saxton, & Furnival, 2002).

Unsurprisingly, upper limb lymphoedema affects a person both physically and psychologically (Poole & Fallowfield, 2002; Pain, Vowler, & Purushotham, 2003). Physical symptoms include numbness, pain, swelling, weakness, stiffness and loss of shoulder mobility. The size and physical changes in the arm may make it difficult to wear the same clothes; work performance is sometimes affected as well (Passik & McDonald, 1998). Psychological issues encompass anxiety, depression, and concern about self-image, all of which interfere with the quality of life. Difficulties with domestic, social and sexual functioning, as well as tasks requiring fine motor coordination, have been reported (Passik & McDonald, 1998). Passik and McDonald note that lymphoedema may have a further detrimental psychological effect on top of the initial breast cancer, which is already emotionally fraught. In light of the significant psychological impact of lymphoedema, treatment should also address these concerns as well as the more obvious physical effects.

Interestingly, lymphoedema is not an inevitable consequence of cancer surgery, but can be triggered by known factors. For example, increased body mass index (BMI), localised infection, air travel (Casley-Smith & Casley-Smith, 1996a; Clark, Wasilewska & Carter, 1997; Erickson, Pearson, Ganz, Adams & Kahn, 2001; Graham, 2002; Mason, 2001; Pain & Purushotham, 2000; Rockson, 1998), trauma and constriction of the affected limb and excessive exercise (Clark, Wasilewska & Carter, 1997; Erickson, Pearson, Ganz, Adams & Kahn, 2001; Pain & Purushotham, 2000; Rockson, 1998). Patients who have had axillary dissection surgery are more likely to develop lymphoedema than those who do not have this procedure (Davis, 2001). Older age and increased BMI may also be associated with the development of lymphoedema because lymphatic pump force decreases with age (Foldi, 1998; Kocak & Overgaard, 2000). Infection sometimes triggers lymphoedema because the lymphatic system's removal of bacteria is compromised (Cohen, Payne, & Tunkel, 2001). Cohen et al. also argue that factors increasing lymphatic loading, including excessive heat, overuse of the limb, and aircraft flight, are triggers for lymphoedema. In contrast, improved surgical techniques, such as sentinel node biopsy, possibly reduce the incidence of lymphoedema given that lymph node removal is unnecessary (Poole & Fallowfield, 2002; Torrenga, Fabry, van der Sijp, van Diest, Pijpers, & Meijer, 2004).

The International Society for Lymphology identifies three grades of lymphoedema (See Table 1). It is also important that physiotherapists recognise that the progression and rate of untreated lymphoedema vary greatly between patients. While there is no cure for the condition symptoms are certainly treatable. The variety of treatment modalities within physiotherapy offers hope for symptomatic patients.

Physiotherapy techniques to treat lymphoedema were first proposed by Winiwarter in 1892 in the publication "Die Elephantiasis" (Mason, 2001). Winiwarter advocated skin cleanliness, elevation, compression bandaging, exercises and massage to disperse oedema (Ko, Lerner, Klose, & Cosimi, 1998; Mason, 2001). However, lymphatic massage was seldom used until 1936 when Vodder developed specific massage techniques known as Manual Lymph Drainage (MLD). In 1975 Foldi (1998) updated MLD proposing Complex Decongestive Physiotherapy (CDP) as a new way to treat lymphoedema (Foldi, 1998). The Foldi technique was adapted in Australia by the Casley-Smiths and Michael Mason, who all instruct and perform Complex Physical Therapy (CPT) for lymphoedema. CPT and CDP refer to the same technique within this review and are used according to the preference of the original authors. CPT is a multi-intervention treatment approach incorporating MLD, compression bandaging and fitted garments, special exercises and meticulous skin care. Other treatment modalities consist of electrotherapy, pneumatic compression, pharmacotherapy and surgery.

However, pneumatic compression is not used as a sole treatment for secondary lymphoedema because the pump assists in reabsorption of water from the limb but leaves protein molecules in situ, which may accelerate development of fibrosis (Mason, 2001). Pneumatic compression is no longer used in New Zealand and will not be discussed further in this review. Surgical techniques, such as liposuction (Brorson, 2000) are not a physiotherapy modality and are therefore outside the scope of this review.

Likewise, pharmacotherapy has been used in combination with physiotherapy to treat the condition in the past. The benzopyrone group of drugs, such as coumarin, reportedly increases macrophages in the affected extremity thereby stimulating proteolysis and reducing lymphoedema (Brennan & Miller, 1998). Despite some positive evidence supporting the use of benzopyrones to treat lymphoedema (Casley-Smith & Casley-Smith, 1992b; Casley-Smith & Casley-Smith, 1996b), coumarin sales have since been suspended in Australia, France, Belgium and Canada (Lymphovenous Canada, 2002), as the drug has been associated with rare and unpredictable cases of liver toxicity, sometimes leading to death. Conflicting evidence about potential side effects means usage is questionable; pharmacotherapy will not be discussed further in this review.

Therefore, this paper will critically analyse the research into the individual treatment components of CPT and CPT as a whole in terms of the results and methodologies used to drive the investigations, the outcome measures and the strengths and limitations. The findings of this analysis will then be discussed in terms of the effectiveness of the physiotherapy treatments for secondary lymphoedema, and finally the recommendations for clinical practice and future research will be presented.

REVIEW

Compression Sleeves and Bandaging

Compression sleeves and bandaging are a common technique to remove lymph and reduce oedema formation by increasing the pressure gradient within the arm (Brennan & Miller, 1998). Garments generally have a varied gradient that reduces fluid, from distal to proximal, by encouraging lymphatic flow back to the torso; bandages are wrapped more tightly distally for the same reason. Fitted compression sleeves are also beneficial to provide a protective barrier against incidental trauma, which can trigger or exacerbate lymphoedema (Brennan, DePompolo, & Garden, 1996).

Twenty years ago Swedborg (1984) used a single group study design to examine elastic compression sleeves to treat lymphoedema in 54 patients. The sleeve reduced swelling by around 8% initially and was maintained for six months, although there was no further follow-up. Small sample size and lack of intervention details limit the research findings.

Similar results were reported in a prospective study of 120 postmastectomy women (Bertelli et al. 1992). Subjects wore sleeves for six hours per day and reduced their arm girth by a mean of 15%. Interestingly, patients who maintained their weight following surgery had a greater reduction in swelling than those who gained weight. This finding was not related to BMI. It is unclear though if swelling reductions were maintained for longer than six months. This research was further complicated because a course of either lymphatic drainage, or pneumatic compression prior to commencement of the intervention, were introduced as well. It is difficult to know which particular treatment modality reduced limb volume.

Another study, a small quasi-experimental study of 25 women with unilateral upper limb lymphoedema, examined the effect of compression sleeves combined with a controlled exercise, skin care and self-massage treatment program (Hornsby, 1995). Fourteen patients in the treatment group wore individually fitted compression sleeves and followed the controlled treatment program. The intervention group lost more fluid from their arm than the control group. Both groups however reported improved psychosocial wellbeing. Wellbeing, defined according to the arm feeling less heavy and more mobile, was measured in a non-standardised questionnaire. The study was limited by a small sample size, lack of patient and examiner blinding and the multiple variables included in the treatment regimen. The duration of the study and follow-up period were not explained. Results provide some evidence to support the use of compression sleeves as part of a treatment program for unilateral upper limb lymphoedema, but the most suitable prescription is still uncertain.

Badger et al. (2000) used a randomised, controlled design to compare multilayer bandaging (MLB) followed by compression garments versus garments alone in 90 women with unilateral upper limb lymphoedema. The intervention group received 18 days of MLB, followed by 24 weeks of compression garments, versus 24 weeks of garments alone in the control group. Volume reduction in the MLB group after 18 days of bandaging was significantly higher. However, subjects in both groups continued with other interventions during the trial, including skin care, exercises and self-massage. This casts some doubt as to whether MLB alone reduced volume. The study was limited by lack of a follow-up to review volume reductions. Furthermore, measurements were only taken three times in 24 weeks of the study and this made it difficult to state when the most reduction in oedema occurred. The authors recognised the problems associated with multiple treatment interventions. While the research provides some evidence supporting MLB as a physiotherapy technique the confounding variables makes firm conclusions questionable.

Manual Lymph Drainage

Another useful physiotherapy technique for established secondary lymphoedema following surgery for cancer is lymphatic massage, such as Manual Lymph Drainage (MLD). Lymphatic massage produces a mild pressure gradient to help remove oedema from the limb (Brennan & Miller, 1998). Massage is potentially useful to stimulate the remaining lymphatic mechanisms to remove the fluid (Morgan, Casley-Smith, Mason, & Casley-Smith, 1992). MLD involves regional massage to move fluid past lymphatic watersheds into territories where the lymphatic system is intact, such as in the trunk (Mason, 2001). MLD is most commonly combined with other therapies, such as skin care, exercises and compression garments, as part of Complex Physical Therapy.

Johansson et al. (1998) compared MLD with sequential pneumatic compression in a clinical trial of 28 women with postmastectomy lymphoedema. Both treatment modalities reduced swelling significantly although statistical significance between the two interventions was not evident. The authors concluded that either intervention was effective, with MLD tending to reduce swelling by a larger amount. MLD also decreased subjective feelings of tension and heaviness, which was not the case when sequential pneumatic compression was used as a single technique. In an attempt to ascertain the psychosocial impact of the treatment regime sensations were measured using a non-validated subjective questionnaire. The small sample size, lack of follow-up, and single therapist performing all treatments, potentially increasing the risk of bias, limited this study.

Andersen et al. (2000) conducted a prospective randomised study examining the effect of combining MLD with CPT. Patients received standard therapy comprising compression garments, exercise and advice on skin care, with or without eight sessions of MLD for two weeks. Significant volume reductions of the affected limb were reported in both groups. The authors concluded however that that the addition of MLD did not significantly contribute to the reduction of oedema volume, which raises questions as to the significance of CPT as an effective technique. In the research the impact of treatment on self-reported patient symptoms was assessed in a non-validated, subjective questionnaire. Little detail on the content of this tool is included. While self-reported symptoms supposedly improved after treatment, the validity of the questionnaire means results should be viewed cautiously. Methodological limitations of this study included small sample size (n=42) and strict entry criteria of mild (grade 1) lymphoedema. Anderson et al. concluded that patients with grade 2 or 3 lymphoedema may benefit from the addition of MLD to their treatment regimen.

Sitzia et al. (2002) designed a pilot randomised trial comparing MLD with a modified version of MLD, called Simple Lymphatic Drainage (SLD), for postmastectomy lymphoedema. MLD apparently reduced swelling by about a third, while SLD reduced swelling by less than a quarter. The authors suggested that reductions from SLD may have been less if patients performed the technique, instead of the therapists, who had more rigorous training in the SLD. While this research is promising in that it supports the efficacy of MLD, limitations relate to the small sample size (n=28), lack of blinding or follow-up, and the absence of psychosocial outcome measures. The authors acknowledged the limitations and supported replication of the study with a larger population sample.

Williams et al. (2002) also compared MLD with a modified version of the same technique in a randomised controlled crossover study. MLD significantly reduced the volume of oedema in subjects, improved quality of life, and reduced pain and disability, although there was no follow-up to check continuing swelling reduction. Quality of life measures included a subjective questionnaire and the EORTC QLQ-C30 questionnaire. It is doubtful if either of these tools has been validated for use in patients with lymphoedema. Sampling problems, small sample size (n=31), and potential bias, as subjects were patients already seeking treatment from a hospital, raise further issues. Thus findings are not readily generalizable to the wider population. Although the study was conducted over 12 weeks there is no evidence of continuing follow-up. The research is also difficult to replicate as MLD was performed utilising the Vodder method, which was not explained. This study provides some evidence to support the use of MLD in treatment of unilateral upper limb lymphoedema but weaknesses in method mean findings should be viewed cautiously.

Exercise

Exercise, a potential trigger for lymphoedema, is controversial as a technique to treat secondary lymphoedema. Over-exertion, particularly in hot weather, and exercise with too much resistance evidently trigger lymphoedema, yet most evidence is anecdotal (Brennan & Miller, 1998; Board & Harlow, 2002). Specific exercises to improve lymph flow are commonly part of complex physical therapy for established lymphoedema (Foldi, 1998; Tunkel & Lachmann, 1998, Cohen, Payne, & Tunkel, 2001). Routines generally start with diaphragmatic breathing as negative intrathoracic pressure improves flow through the Cisterna Chyli and thoracic duct, then back to the junction of the left subclavian and internal jugular veins. This is followed by a series of movements, which exercise the joints sequentially from proximal to distal (Mason, 2001). Many authors consider that performing exercise with a compression sleeve or bandages on will improve muscular pumping action, therefore increasing uptake of lymph at the lymphagions (Brennan & Miller, 1998; Casley-Smith, Boris, Weindorf, & Lasinski, 1998; Pain & Purushotham, 2000).

Swimming is proposed as an ideal form of exercise for lymphoedema sufferers as the water provides compression and overheating is unlikely. Heated pools should be avoided as they may increase swelling. Aerobic exercise is beneficial because it improves the muscle pump action, controls the BMI, and may improve quality of life (Turner, Hayes, & Reul-Hirche, 2004). Heavy resistance training for people with lymphoedema, or who are at risk of developing it, is generally not recommended, although guidelines as to how much is too much resistance are lacking. McKenzie and Kalda (2003) used a pilot randomised controlled trial to assess the effect of an upper limb exercise program on arm swelling in 14 lymphoedema patients. There was no increase in arm swelling as measured by arm circumference and volume displacement after eight weeks of resistance and aerobic training. Patients performed three sets of ten repetitions in six upper body exercises, and used an upper limb cycle ergometer for aerobic exercise. The amount of weight used for resistance exercise is not described. While the authors reported a trend towards increased quality of life as measured by the SF-36 questionnaire this change was not statistically significant. Additionally, the SF-36 has not been specifically validated in patients with lymphoedema. Nonetheless, McKenzie and Kalda concluded that the lack of increase in swelling and trend towards increased quality of life were sufficient reasons to include exercise therapy as part of lymphoedema management.

Another pilot study of an eight-week moderate intensity exercise program following breast cancer apparently improved quality of life, as measured by the FACT-B questionnaire, without precipitating or exacerbating lymphoedema (Turner, Hayes, & Reul-Hirche, 2004). It is uncertain how sensitive the FACT-B is to changes in lymphoedema patients, although a modified version of this tool, the FACT-B+4, has been validated in patients with lymphoedema (Coster, Poole & Fallowfield, 2001). Even though this study was limited by small sample size and lack of a control group, it provided statistically significant evidence of improvements in quality of life and highlights the need for further research in this area.

Skin Care

Skin care plays a part supporting physiotherapy techniques in the treatment of secondary lymphoedema. Meticulous skin care reduces the risk of infection and injury, and protects skin during daily activities (Foldi, 1998; Cohen, Payne & Tunkel, 2001). Practice should include use of moisturisers, topical antibiotics for scratches and insect bites, and prompt treatment of any fungal infection (Casley-Smith, Boris, Weindorf, & Lasinski, 1998; Foldi, 1998). Runowicz (1998) reports that compliant patients have a reduced incidence of lymphoedema but Louden and Petrek (2000) contend that there is no clinical data to support the use of skin care measures in lymphoedema treatment. Harris et al. (2001) also state that meticulous skin care is supported by clinical experience, but not by research. Despite an apparent lack of evidence to support skin care, it appears reasonable to include it in CPT because of the role of infection as a potential trigger factor for lymphoedema.

Electrotherapy

Electrotherapy is seldom used to treat secondary lymphoedema. However, there appears to be some potential here. Carati et al. (2003) used a double blind, placebo controlled trial to examine the effect of laser therapy on women with unilateral postmastectomy lymphoedema. The study compared laser with sham treatment, and one course of laser therapy with two courses of laser. Limb volume, dermal tonometry (a measure of skin thickness and elasticity) and upper limb range of motion were measured. While one course of laser treatment did not improve the outcome measures, two cycles of treatment significantly reduced limb volume in one third of subjects within 2-3 months of completing therapy. Results though are questionable because of the small sample group (n=61; 33 laser, 28 control), absence of quality of life measures and a lack of information about how the intervention worked. Additionally, the lead author of this study occasionally acts as a consultant for the company that manufactured the laser equipment used in the study, which suggests a conflict of interest. It was stated that the manufacturer had no input into the analysis or preparation of the article. Despite these problems laser treatment could be useful in chronic lymphoedema because of its effect of softening fibrotic tissue (Mason, 2001). Laser may be a promising intervention in the future but the long-term gains cannot be assumed.

Complex Physical Therapy

Complex Physical Therapy (CPT) is utilized to treat secondary lymphoedema. CPT is a multi-modality treatment approach comprising compression garments and bandaging, manual lymph drainage, exercises and skin care. Casley-Smith and Casley-Smith (1992a) investigated the use of CPT to treat 78 postmastectomy upper limbs and 132 lower limbs with a mixture of primary and secondary lymphoedema in a clinical trial. CPT significantly reduced the amount of swelling in all grades of lymphoedema over four weeks. Patients with grade 2 or 3 lymphoedema experienced greater reductions in swelling than grade 1 lymphoedema. Reductions in limb volume were sustained for 12 months when fitted compression garments were worn day and night. A further course of treatment after 12 months produced a similar reduction in volume to the first treatment. This study lacked a control group and the multiple interventions used, which make it impossible to evaluate the relative effect of each component of CPT. The study was also limited by a lack of information about modalities used and referred to other, unobtainable, articles for details of participants and the interventions. No quality of life measures were used to assess any psychosocial or functional changes in the patients. Despite these limitations, and if the relative contributions of each intervention are put aside, this study presents a strong case supporting CPT as an effective technique as long as it is administered by experienced therapists.

Morgan et al. (1992) evaluated results from the same sample of 78 patients with upper limb lymphoedema. Oedema was reduced by over 50% in patients after one course of treatment, and by 50% after a second course one year later. Patient compliance was highlighted as a key feature of the intervention, especially in the maintenance of reduced swelling. It was disappointing that quality of life issues were not measured.

One of the few larger studies on the topic (Ko, Lerner, Klose, & Cosimi, 1998) reported on a prospective study of 299 consecutive patients referred for treatment of lymphoedema via Complex Decongestive Physiotherapy (CDP). Subjects underwent CDP for an average of 15 days, and were followed up at 6 and 12 months afterwards. Oedema was reduced on average by over 50% and compliant patients maintained around 90% of the initial reduction with compression sleeves, exercises and skin care. The functional significance of these reductions was not discussed. The authors believed patient compliance had a significant impact on maintaining reductions in swelling, as non-compliant patients lost more of their initial gains than compliant patients. The lack of randomisation and statistical information limited the study, and it was again impossible to deduce the relative contribution of each component of CDP to the reduction in lymphoedema.

Several studies have evaluated modified CPT routines with different components. For example, one crossover study design investigated combinations of massage, isometric exercise and elastic sleeves to treat postmastectomy lymphoedema and found that each treatment regimen reduced oedema by 10% after four weeks (Swedborg, 1980). Volume reductions were sustained if an elastic compression sleeve was worn afterwards, although it is unclear how long for. However, findings are problematic. Treatment detail is unclear, sample size is small (n=39) and psychosocial outcome measures are not part of the study.

Bunce et al. (1994) trialled modified CPT with pneumatic compression in a prospective study of 25 consecutive referrals. Compression garments reduced limb volume on average by 40% over four weeks, maintained for 12 months. The authors considered that volume displacement was the only reliable way to measure lymphoedema because of the irregular shapes of limbs and hands. Once again, the small sample size, lack of psychosocial measures and use of multiple treatment modalities limit findings.

Similarly, Mirolo et al. (1995) examined the effect of modified CPT with pneumatic compression in a clinical trial of 25 women. Subjects reported reduced oedema, improved feelings of quality of life, increased functional independence, and improved body image. Follow-up assessments at 6 and 12 months found that quality of life improvements and reductions in oedema continued. Authors used the Functional Living Index--Cancer to develop a new tool, the Wesley Clinic Lymphoedema Scale to assess changes in quality of life. No information regarding the validity or reliability of this tool was given.

In another clinical trial of 220 non-hospitalised women Leduc et al. (1998) reported on the effects of MLD, intermittent pneumatic pressure and multilayered bandaging on reducing secondary lymphoedema. Oedema reduced by up to 50% in the first week of treatment, tapering off by the end of week two. However, the lack of randomisation, control and blinding of therapists to outcomes limits findings and no quality of life measurements were reported. The research design is poorly described, thus limiting reproduction, and once again the relative contribution of each treatment modality is vague.

Hinrichs et al. (2004) give details of a retrospective study of the effect of CDP without skin care on lymphoedema arising from groin dissection for melanoma. While CDP reduced lymphoedema by 60%, a raised BMI impacted negatively overall. Once more the small sample (n=14), absence of quality of life measurement and lack of randomisation or blinding of therapists weakens results. It was also difficult to know if limb volume reductions were maintained or how long CDP was applied for.

Clearly, evaluating the effectiveness of complex physical therapy is difficult. Because the incidence is unpredictable it is important to pre-empt the condition if possible. Box et al. (2002) conducted a study to determine whether prospective monitoring and early intervention with CPT affected the incidence of lymphoedema after axillary dissection for breast cancer. The authors found that early diagnosis and treatment of lymphoedema had a significant impact in slowing the progression of lymphoedema. Volume measurement of the affected limb was the most sensitive method of determining early onset of lymphoedema. After two years of follow-up 30% of the control group had developed lymphoedema, as opposed to 10% of the intervention group. Additionally, early treatment of the intervention group with CPT allowed some patients to control their lymphoedema adequately by the 24-month follow-up mark. A potential risk factor for the development of secondary lymphoedema was increased Body Mass Index (BMI). The research, like many others, was somewhat limited by its small sample size (n=68), although this was recognised by the authors. One particular point of interest that was evident was that subject's self-perception of increased arm swelling did not always correlate to a clinically significant increase in volume. 28% of women felt their arm was swollen at the 24-month follow-up, despite the fact that clinical manifestations of secondary lymphoedema were not present.

Outcome measures

Outcome measures determining the effectiveness of physiotherapy techniques to treat secondary lymphoedema are important. Outcome measures should be reliable, valid and sensitive to changes in the condition of the patient. Common outcome measures used in lymphoedema research and treatment include arm circumference, arm volume, as calculated using a cone formula, and arm volume via water displacement. Other measures used less often include dermal tonometry and limb range of motion. Few studies have used quality of life measures, whether they are general questionnaires, such as the SF-36, or measures designed specifically for lymphoedema patients such as the FACT-B+4 (Coster, Poole, & Fallowfield, 2001). There is a very real need for valid and reliable quality of life measures and questionnaires to acknowledge the effect that lymphoedema has on the patient and their function. Psychological distress may be related to how well patients manage and adjust to the complications that lymphoedema can cause (Coster et al. 2001). Likewise, several studies have found that lymphoedema is associated with significant functional impairment, which substantially affects the social and physical functioning of the patient (Sitzia & Sobrido, 1997; Velanovich & Szymanski, 1999). Questionnaires to assess patient quality of life should ideally be administered throughout the treatment regime as regular screening of patients with lymphoedema may assist the psychological adjustment to treatment (Tobin, Lacey, Meyer, & Mortimer, 1993). Identification of patients who may be at risk of developing psychological problems could help improve treatment outcomes and assist physiotherapists with the management of lymphoedema physically and socially (Passik & McDonald, 1998).

According to Gerber (1998) circumferential measurements are the most regularly used method of measuring lymphoedema. The author points out that there are many limitations in the application of circumferential measurements and volume calculations. Therapists may stretch the tape measure over time when measuring limb circumference, thereby inadvertently interfering with the measurement. However, circumferential measurements have an advantage in that they are easy to apply within the clinical setting. Volumetric measurements are applied most commonly via water displacement, where the limb is submerged in water and the water displaced is measured to distinguish limb volume (Brown, 2004). On the one hand this outcome measure has been tested and shown to be reliable in measuring limb volume (Kelly, Armer, Wipke-Tevis, & Williams, 2002). On the other hand, setting up the method is time consuming so it may not be economically viable or practical in clinical practice (Brown, 2004). Clearly, there is a need for valid and reliable quality of life measures and questionnaires, so that comparisons between the outcome measures and the effect that lymphoedema has on the patient and their functional abilities, are possible.

RESULTS

From this literature review it is evident that there are several gaps in the knowledge concerning physiotherapy treatment for established secondary lymphoedema. While research supports CPT to treat lymphoedema most studies have methodological limitations in terms of sample sizes and lack of control groups. Additionally, many studies fail to detail their intervention protocols clearly and thus are not reproducible. Many study populations are very specific which reduces the application of results to a wider population. While CPT as a whole appears to reduce lymphoedema significantly, the relative contributions of each individual modality within the treatment regime is unclear and needs further investigation. Most lymphoedema research should therefore be viewed with caution in light of these limitations.

DISCUSSION

From this literature review it is evident that there is no effective single intervention to treat secondary lymphoedema. A combined approach of CPT appears to produce significant reductions in swelling that may be well maintained in compliant patients, but the research to support CPT has several limitations. CPT studies have been generally clinical case reports of treatment that occurs in clinics, with small sample sizes, no blinding of therapists or patients to treatment, and no control group. Outcome measures tend to concentrate on limb volume measures and ignore quality of life measurements or functional outcomes. Some studies have attempted to add a psychosocial element to their research by using subjective questionnaires (for example Andersen, Horjris, Erlendsen, & Andersen, 2000; Johansson, Lie, Ekdahl, & Lindfeldt, 1998) but the tools used have not been shown to be valid or reliable in this patient group. Future research designs could make use of validated quality of life measures such as the FACT-B+4, a version of which was used by Taylor et al. (2004). Better quality evidence will allow physiotherapists and other lymphoedema practitioners to make informed recommendations about best practice to avoid developing lymphoedema after surgery for breast cancer. Education of patients in susceptible populations appears to have a positive effect on reducing the incidence of lymphoedema (Box, Reul-Hirche, Bullock-Saxton, & Furnival, 2002). Clearly, prevention and early identification of lymphoedema improves treatment outcomes as lymphoedema is harder to treat when well established. It is somewhat surprising that there is little research into trigger factors and prevention of lymphoedema, since the disease, once established, has no cure.

Studies of compression modalities by Hornsby (1995) and Badger et al. (2000) were limited by small sample sizes lack of patient and examiner blinding and the multiple variables included in the treatment regimen. Findings may not be readily generalizeable due to the small sample sizes. Additionally, the duration of the study and presence of any follow-up period was unclear in Hornsby's research. Badger et al. did acknowledge the limitation of the presence of multiple treatment interventions in the one study. Their results provide some evidence to support the use of compression sleeves as part of a treatment program for unilateral upper limb lymphoedema, but the most suitable prescription is unclear. Compression sleeves and bandaging are important adjuncts to a CPT program to maintain the reductions made during treatment.

Studies of MLD, exercise, skin care and laser are limited in number. Johansson et al. (1998) suggest that grade 2 or 3 lymphoedema may benefit from the addition of MLD to their treatment regimen. The findings of Sitzia et al. (2002) and Williams et al. (2002) provide some evidence to support use of MLD, but better quality research with larger samples and follow-up periods is needed. There is no specific research to quantify the effect of exercises to increase lymphatic function, thus research is needed to assess the effect of exercise for improving lymphatic flow. However, moderate intensity aerobic and resistance exercise appears to improve patient quality of life without exacerbating arm lymphoedema symptoms. Harris et al. (2001) state that meticulous skin care is supported by clinical experience, but not by research. Despite an apparent lack of evidence to support skin care, it appears reasonable to include it in CPT because of the role of infection as a potential trigger factor for lymphoedema. The effects of laser in softening fibrotic tissue mean that laser treatment may be more useful in chronic lymphoedema (Mason, 2001). Laser may be a promising intervention for treating grade 2 or 3 lymphoedema, but rigorous research into the effectiveness of this intervention and the lasting benefits is necessary. Results from existing trials are not as strong as for CPT, which makes the use of laser questionable on the basis of cost and efficacy.

According to case studies CPT apparently has good results, but there is a lack of high quality randomised, controlled trials supporting CPT. Casley-Smith and Casley-Smith (1992a) present a strong case for supporting CPT when administered by experienced therapists, without considering the relative contribution of each component of the intervention. Ko et al. (1998) found that patient compliance had a significant impact on the maintenance of reductions in swelling, as noncompliant patients lost more of their initial gains than compliant patients. It is again difficult to deduce the relative contribution each component of CPT has reducing lymphoedema. Modified CPT appears to be useful in treating secondary lymphoedema, but once again research is generally limited by small sample size and poor research designs. The ethical implications of withholding treatment from a control group that already had lymphoedema may contribute to this. What is clear though is that practitioners disagree about the optimal CPT regime, and whether modified versions of MLD should be used as they are less time consuming and cheaper to administer. It is possible that there is no one best regime of CPT suitable for all patients who present very differently.

Recommendations for clinical practice and research

Early identification of lymphoedema in susceptible populations is an essential part of clinical practice. Education of practitioners to recognise signs and symptoms of early onset lymphoedema will assist treatment and produce better outcomes for patients. Evidence exists to support the use of CPT to treat lymphoedema, and referral to experienced practitioners is recommended to ensure best possible care.

In terms of research, while several studies have evaluated CPT in patients with lymphoedema after breast cancer (Casley-Smith et al., 1992a; Morgan et al., 1992; Ko et al, 1998), other studies have used modified CPT protocols and varied follow-up periods (Bunce et al., 1994, Mirolo et al., 1995; Leduc et al., 1998). Only one study (Mirolo et al. 1995) included a quality of life measurement as part of their outcome measures, and there appears to be little consensus as to the optimal regimen of CPT. None of these studies incorporated any form of randomisation or control group, and the reporting of methodology was questionable in some cases. From an ethical perspective it is difficult to perform randomised controlled trials of lymphoedema treatment, as it is not ethically sound to withhold treatment from someone who requires it. Therefore the use of prospective studies is advocated with best possible methodology within this construct. Therapists should be blinded to treatments, outcome measures should be reliable and valid, and quality of life and function should be a part of treatment outcomes. There is potential to develop a quality of life questionnaire for both clinical practice and research. Additional research into trigger factors for lymphoedema and the efficacy of laser, lymphatic exercises and skin care would further increase the evidence-based knowledge pool on lymphoedema therapy.

Consequently, a prospective study utilising CPT as detailed by in Mason (2001) is proposed, along with examination of the effect of lifestyle factors on maintenance of volume reduction through a self-report diary. A validated quality of life questionnaire sensitive to lymphoedema, such as the FACT-B+4, would be used to measure the psychosocial effects of treatment. This study would be followed up for 24 months in order to gather information about the maintenance of arm condition in treated patients.

CONCLUSION

From this review it is evident that while CPT may be an effective treatment regimen for secondary lymphoedema, there is wide disagreement amongst researchers as to the optimal components and timeframe of the intervention. Research is limited by poor or poorly described study designs with small sample sizes, and this must be remedied in the future for lymphoedema treatment to gain a sound evidence base for practice. This paper has reviewed much of the available evidence for physiotherapy treatments of lymphoedema, and found that while physiotherapy is effective there needs to be a more unified approach to treatment and consideration of psychosocial factors as well as physical changes in the outcome measures utilised, if patients are to benefit.

ACKNOWLEDGEMENTS

Our thanks go to two who have assisted us in the presentation of this paper. Cath Noventa (MNZSP and a Mason-trained lymphoedema therapist) suggested this topic for review and provided invaluable assistance by proof reading the manuscript and explaining the technical aspects of lymphoedema treatment. Dr Antoinette McCallin, Senior Lecturer, Department of Health Care Practice, Auckland University of Technology, provided excellent feedback about the content and structure of the paper and helped with structural alterations for final submission.

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ADDRESS FOR CORRESPONDENCE:

sandra.bassett@aut.ac.nz

Mike McCallin, MA(Hons), BHSc(Physio), BA * Jena Johnston, BHSc(Physio) *

* At the time this paper was written, these authors were 4th year students at the Auckland University of Technology School of Physiotherapy

Sandra Bassett, BA, MHSc(Hons), DipPhty Senior Lecturer, School of Physiotherapy Auckland University of Technology, New Zealand.
Table 1: International Society for Lymphology Grades of Lymphoedema

Grade of Lymphoedema Description of symptoms

Grade 1 Pitting oedema with pressure, may be reduced
 with elevation
Grade 2 No pitting, larger, fibrotic limb, skin and
 nail changes
Grade 3--Elephantiasis Thick skin with huge folds, marked skin
 deterioration

Adapted from: "Modern treatment of lymphoedema. I. Complex physical
therapy: the first 200 Australian limbs" by J.R. Casley-Smith & J.R.
Casley-Smith, 1992a, Australasian Journal of Dermatology 33(2), p.65.

Table 2: Characteristics of Lymphoedema Studies

 Experimental
Reference design Subjects Intervention

Andersen et Prospective 42 women Standard
al. (2000) randomised treated for therapy:
 study breast cancer skin care,
 education,
 exercises &
 CG
 Standard
 therapy &
 MLD for 2
 weeks

Badger et Randomised 83 of 90 18 days MLB
al. (2000) controlled consecutive followed by
 parallel group referrals to CG
 trial Lymphoedema
 clinic CG alone 24
 weeks

Bertelli et al. Prospective 120 Electric
(1992) trial postmastectomy lymphatic
 women with drainage
 axillary node (n=83)
 dissection; IPC (n=34)
 results from 107 CG 6 hrs/day
 (all)

Box et al. Prospective 65 women after Education,
(2002) Randomised surgery for monitoring
 controlled breast cancer and early
 study CPT if
 needed

Bunce et al. Prospective 25 consecutive Massage,
(1994) cohort study postmastectomy SPC,
 women MLB and
 exercises

Carati et al. Randomised 61 women 3 weeks laser
(2003) double blind, with unilateral treatment 1.5
 placebo upper limb joules/cmp
 controlled lymphoedema 8 week gap
 crossover trial between
 treatment
 blocks

Casley-Smith Clinical trial 78 CPT for 4
et al. postmastectomy weeks
(1992a) arms and
 128 legs with
 lymphoedema
 of varied origin

Hinrichs et Retrospective 14 patients CPT for 4
al. (2004) study with leg weeks
 lymphoedema

Hornsby Quasi- 25 of 58 CG worn 24
(1995) experimental consecutive hrs/day
 randomised referrals to
 controlled trial cancer clinic CG and
 control
 group did
 exercises,
 skin care
 and self-
 massage

Johansson Clinical trial 28 consecutive CG 2 weeks
et al. (1998) postmastectomy then:
 women with MLD 2 weeks
 axillary node or SPC 2
 dissection weeks

Ko et al. Prospective 299 consecutive CPT for
(1998) study patients with mean 15
 arm and leg days
 lymphoedema
 of mixed origin

Leduc et al. Clinical trial 220 women post MLD
(1998) breast cancer IPC
 surgery MLB

McKenzie et Randomised 14 women with 8 week
al. (2003) controlled pilot unilateral arm upper limb
 study lymphoedema resistance
 and aerobic
 exercise
 program

Mirolo et al. Clinical trial 25 women with Massage,
(1995) lymphoedema SPC,
 after breast MLB and
 cancer education
 CG for
 maintenance

Morgan et Clinical trial 78 consecutive CPT
al. (1992) postmastectomy
 women

Sitzia et al. Pilot 28 women MLD
(2002) randomised with unilateral
 trial lymphoedema SLID by the
 patient

Swedborg Crossover trial 39 women with Massage,
(1980) postmastectomy exercise and
 lymphoedema CG in three
 combinations

Swedborg Single group 54 from 249 CG
(1984) study consecutive IPC 6 hrs/day
 referrals for CG for
 postmastectomy maintenance
 treatment

Turner et al. Pilot study 10 women 8 week
(2004) treated for upper body
 breast cancer aerobic and
 moderate
 resistance
 program


Williams et Randomised 31 women MLD daily for
al. (2002) controlled with breast 3 weeks
 crossover study cancer related
 lymphoedema SLD for 3
 weeks

 6 week
 break
 between
 crossover

 Study Outcome
Reference length measures Results

Andersen et 12 months Arm volume Mean
al. (2000) from reduction 43%
 circumference at 1 month
 measures Reductions
 Shoulder RoM were
 Subjective maintained at
 questionnaire 12 months

Badger et 24 weeks Limb volume 31% reduction
al. (2000) No follow-up via electronic with MLB
 device or limb 15% reduction
 circumference CG
 measures,
 compared to
 normal limb

Bertelli et al. 6 months Sum of arm Mean
(1992) No follow-up circumferences reduction
 14.7%
 Maintained for
 4 months

Box et al. 24 months Arm 11% incidence
(2002) circumference in treatment
 Limb volume group
 via water 30% incidence
 displacement in control
 group

Bunce et al. 4 weeks Arm volume Initial
(1994) 6 & 12 from reduction 40%
 month circumference 50% reduction
 follow-ups measures at 6 months

Carati et al. 30 weeks Dermal 2 cycles of
(2003) tonometry laser treatment
 Arm reduced
 circumference lymphoedema
 Shoulder RoM in 31% of
 Subjective subjects
 questionnaire

Casley-Smith 12 months Arm volume Mean
et al. from reduction arms
(1992a) circumference 60%
 measures Mean
 reduction legs
 50%

Hinrichs et 4 weeks Leg volume Mean
al. (2004) No follow-up from reduction in
 circumference volume was
 measures 60%

Hornsby 4 weeks Limb volume 12/14 in CG
(1995) No follow-up via water group reduced
 displacement swelling
 Arm 4/11 control
 circumference group reduced
 Non- swelling
 standardised Improved QoL
 QoL
 questionnaire

Johansson 4 weeks Arm volume CG reduced
et al. (1998) No follow-up by water 7%
 displacement MLD reduced
 Arm mobility & 15%
 strength SPC reduced
 Subjective 7%
 questions MLD improved
 about limb subjective
 tension & feelings
 heaviness

Ko et al. 3 weeks Limb Mean
(1998) 6 & 12 volume from reduction arms
 month circumference 59.1%
 follow-ups measures Mean
 reduction legs
 67.7%

Leduc et al. 2 weeks Arm volume Mean volume
(1998) Variable from reduction 50%
 follow-up circumference
 measures

McKenzie et 8 weeks Arm volume No change in
al. (2003) by water limb volume in
 displacement exercise group
 SF-36
 Questionnaire

Mirolo et al. 4 weeks Arm volume Mean volume
(1995) 12 month from reduction 40%
 follow-up circumference Improved
 measures QoL on
 FLIC QoL Wesley Clinic
 questionnaire Lymphoedema
 Wesley Clinic Scale
 Lymphoedema
 Scale

Morgan et 4 weeks Arm volume Reduction
al. (1992) 12 month from mean between
 follow-up circumference 14.3-30.6%
 measures Maintained at
 follow-up

Sitzia et al. 2 weeks Arm volume MLD mean
(2002) No follow-up from reduction
 circumference 33.8%
 measures SLID mean
 reduction
 22.0%

Swedborg 6 months Arm volume Each
(1980) by water treatment
 displacement reduced
 volume by
 11-13%

Swedborg 6 months Arm volume Mean
(1984) No follow-up from reduction 17%
 circumference sleeve
 measures Further
 18% mean
 reduction with
 IPC

Turner et al. 8 weeks Submaximal No adverse
(2004) Follow up exercise test effect on
 at 6 & 12 FACT-13 QoL lymphoedema
 weeks questionnaire Improved QoL
 Arm scores
 circumference

Williams et 12 weeks Arm volume MLD mean
al. (2002) No follow-up from reduction 71 ml
 circumference SLD mean
 measures reduction 30 ml
 Calliper creep MLD improved
 Dermal tonometry and
 tonometry EORTC QoL
 QLQ C30 QoL SLD no change
 questionnaire
 Subjective
 questionnaire

Note. CG =Compression sleeve or garment, CPT = Complex Physical Therapy
(skin care, lymphatic massage, compression bandaging followed by
garments and lymphatic exercises), IPC = Intermittent Pneumatic
Compression, MLB = Multi-Layered Bandaging, MLD = Manual Lymphatic
Drainage, QoL = Quality of Life, RoM = Range of Motion, SLD =
Simplified Lymphatic Drainage, SPC = Sequential Pneumatic Compression.
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Author:McCallin, Mike; Johnston, Jena; Bassett, Sandra
Publication:New Zealand Journal of Physiotherapy
Geographic Code:8NEWZ
Date:Nov 1, 2005
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