Suehiro, K., Honda, S., Kakutani, H., Morikage, N., Murakami, M., Yamashita, O., . . . Hamano, K. (2014). A novel arm sleeve for upper extremity lymphedema: A pilot study. Annals of Vascular Diseases, 7, 134–140. 

DOI Link

Study Purpose

To investigate the safety and efficacy of a novel arm sleeve composed of a conventional arm sleeve extending to a wider area of the body

Intervention Characteristics/Basic Study Process

Subjects who already used their own arm sleeves used a new conventional arm sleeve during the daytime for two weeks, followed by a novel sleeve during the daytime for two weeks. The characteristics of the arm part of the novel sleeve are the same as those of the arm part of the conventional sleeve. A large elastic body piece to cover the shoulder and the body trunk was attached to the novel sleeve. During the study, the subjects were allowed to use their own mittens or gloves.

Sample Characteristics

  • N = 5
  • MEDIAN AGE = 70 years (range = 48–78 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Postmastectomy upper extremity lymphedema; stage 2 lymphedema; and in the maintenance phase of complex physical therapy (i.e., all subjects used their own sleeves prior to enrolling in the study)

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care  

Study Design

Pre- and post-test design with repeated measures

Measurement Instruments/Methods

  • Arm circumference
  • Questionnaire for arm-related symptoms
  • Interface pressure measured using an air pack-type analyzer
  • Subcutaneous fluid distribution measured by magnetic resonance imaging

Results

When a new conventional arm sleeve was provided to participants, total arm volume (p < 0.05) and percentage of arm volume (p < 0.05) was reduced. When participants were given the novel sleeve, arm volume and percentage volume were reduced, but these changes were not statistically significant.

Conclusions

The novel arm sleeve was associated with some additional reduction in arm volume, but these changes were not significant. The conventional arm sleeve, however, did produce a significant reduction in arm volume when a new sleeve was provided to participants.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition) 
  • Findings not generalizable

Nursing Implications

The sample for this study was extremely small, making the results difficult to generalize. Although the study showed that the novel arm sleeve provided some benefits for the management of arm lymphedema, well-designed studies with larger sample sizes are needed to replicate and examine the effectiveness of this intervention.