The efficacy of physiotherapy upon shoulder function following axillary dissection in breast cancer, a randomized controlled study

According to the European Network of Cancer Registration (1999) the incidence of breast cancer in women in the Netherlands is the highest in Europe with figures of 120/100,000. The mean age at which breast cancer is detected is 60 years [1]. Approximately 40% of these women have a metastasis in the axillary lymph nodes, indicating that cancer has possibly spread beyond the breast. The axillary lymph node dissection (ALND) carries a high morbidity, however, as a result of the sentinel node procedure the number of patients with ALND is decreasing. Following surgery with ALND, 73% of women reported restricted shoulder mobility, tightness, edema, pain, numbness of the arm, and limitations in daily life [2, 3]. These complaints could be due to tissue and nerve damage. In general, the arm-related complaints usually decrease within three months [4, 5]. However, they may also become chronic. The extent of the problem is often underestimated. A study addressing quality of life in patients with breast cancer showed that 74% of the women felt that the ALND had adversely affected their lives [6]. Scar tissue, edema, numbness and possible brachial plexus traction could be the cause. An investigation of recovery of upper limb function after ALND in 76 women by Gosselink et al. showed that three months following surgery, upper limb function is still impaired in a significant number (27%) of patients [7].

Unrelated to breast cancer, there is a high prevalence (7–36%) of musculoskeletal shoulder disorders in the population resulting in considerable pain and disability. Physiotherapy is often the first choice of treatment and has been proven to be effective for these shoulder disorders [8]. However, there is no evidence of the efficacy and effectiveness of physiotherapy for shoulder complaints related to breast cancer and ALND. Kärki et al. deducted from their review that physiotherapy could play an important role in the post-operative treatment of patients with shoulder/arm complaints following breast cancer surgery [5]. Furthermore, Box et al. concluded in their RCT that a postoperative physiotherapeutic protocol is effective in facilitating and maintaining the recovery of shoulder movement [9]. The authors of the review found no evidence showing that the start of early exercises is beneficial. One of the few randomized studies concerning the effect of physiotherapy in patients after breast cancer with ALND showed that physiotherapy leads to a faster functional recovery of the arm [10]. However, follow-up time was short (one to three months). A recent randomized study by Lauridsen et al. (2005), (n = 139), showed a significant improvement of shoulder function after they received team instructed physiotherapy [11]. This study also indicated that patients with breast-conserving therapy showed less severe and less frequent shoulder problems than patients with modified radical mastectomy. Besides the type of surgery the effect of physiotherapy was influenced by adjuvant radiation therapy.

There is no standard referral for physiotherapy following ALND and the disabilities of pain and shoulder dysfunction following this surgery can be severe. The aim therefore of this research is to gain insight into the efficacy of physiotherapy following breast cancer with ALND. The primary measures included shoulder mobility, shoulder and arm function and pain, with quality of life also being assessed.

The efficacy of physiotherapy was assessed in a prospective study by comparing two groups of patients who were randomly assigned to a physiotherapy group (exercise therapy) or to a control group. The study was performed from July 2003 to January 2005 and patients enrolled between August 2003 and June 2004. Patients were recruited from the Radboud University Nijmegen Medical Centre (RUNMC) and the Canisius Wilhelmina Hospital (CWZ) Nijmegen in The Netherlands. Patients with breast cancer having to undergo surgery with ALND, were considered eligible for the study and had to meet the following criteria: 18 years of age and older with an ALND, following breast cancer, a Visual Analogue Scale (VAS; 0–10) pain score of 1 or more and moderate shoulder disabilities in daily life (minimal 3 points on a 5 points disability score list). Patients were excluded with a previous contra-lateral breast cancer surgery and insufficient knowledge of the Dutch language to fill in the questionnaires. Informed consent was obtained from all subjects, and the regional medical ethics board approved the study.

Patients were given a subject information sheet by a member of the nursing staff during their hospital stay. Patients who were willing to participate in the trial attended the Department of Physiotherapy for physical assessments two weeks after surgery, which was concurrent to the first outpatient clinic visit to the surgeon. Baseline measurements were assessed and patients who met the inclusion criteria signed an informed consent. Random assignment was done by an independent co-worker of the department into one of the two groups. The treatment group received specific physiotherapy treatment and the control group had no physiotherapy. Concealed randomization was achieved using a computer-generated random list, which was kept by the co-worker. All assessments were done at the RUMC Department of Physiotherapy by a single researcher, who did not participate in the treatment of the patients. The researcher was blinded to the treatment allocation and patients were instructed not to discuss their treatment with the researcher. The researcher made a note after the final assessment, to which group allocation that she thought the patient belonged.

Ten patients in the treatment group improved, in participation in social activities and less avoiding heavy work around the house (SIP: p = 0.035). The DASH showed an improvement of shoulder mobility and shoulder/arm disabilities in the treatment group (p = 0.017). For an overview of the effect sizes see Table 4.

Comparison of both groups at six months after intake showed that, except for the SIP, the above-mentioned improvements continued. All physiotherapists who treated patients in the intervention group reported that they had complied with the given instructions and exercises (passive, assisted and active) in nine sessions. Ten (66%) physiotherapists had applied soft tissue massage to the surgical scar, two used (13%) lymph drainage for minimization of edema and four (26%) physiotherapists started with exercises to improve the general physical condition. Eleven (73%) physiotherapists indicated that the number of treatment sessions was sufficient, three (20%) that the number was insufficient and one (7%) that the number was too high. Seven of the eleven physiotherapists indicated that further treatment continuation could be beneficial for the improvement of the general physical condition. The researcher was successfully blinded for treatment allocation of patients; in 60% of the cases treatment allocation was guessed correctly.

This study showed that physiotherapy, which began two weeks after surgery, improved shoulder function and quality of life and reduced shoulder pain in patients with axillary dissection in breast cancer with substantial effect sizes. Handgrip strength showed a positive trend, however this was not markedly impaired postoperatively. The volume of the related arm showed little change with edema commonly occurring at a later stage after surgery. Significant improvement in the psychosocial situation was measured by the SIP. Despite the fact that this questionnaire is not a disease specific instrument, it gives a general idea about how patients cope in daily life. Most patients indicated at intake that they avoided social activities and this improved greatly following therapy.

A sample size calculation was not performed for pain and shoulder mobility in breast cancer patients as insufficient information was available. Outcomes of this study may be used for calculations in a larger effect study, as there are currently no available gold standards.

Physiotherapy reduces pain and improves shoulder function and quality of life following axillary dissection in breast cancer.