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A randomized pilot study on self-management in head and neck lymphedema
McLaughlin TM, Broadhurst JJ, Harris CJ, McGarry S, Keesing SL
Laryngoscope Investigative Otolaryngology 2020 Oct;5(5):879-889
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The purpose of this pilot trial was to determine the feasibility of a self-managed lymphedema randomized control trial to test the effectiveness of a head and neck-specific exercise protocol. METHODS: Nine participants were randomized to receive usual treatment provided by an Australian metropolitan teaching hospital (n = 4) or usual treatment with an added head and neck exercise regime (n = 5). Feasibility was assessed through ease of recruitment, adherence, and safety. Lymphedema reduction and quality of life (QOL) data were assessed at baseline (0 week) and follow-up (6 weeks). RESULTS: The study was feasible in terms of safety and participant retention. However, a slow recruitment rate and low adherence may impact future trials. There were no significant differences in lymphedema reduction or QOL between groups. CONCLUSION: This pilot feasibility study demonstrated that a self-management trial can be implemented, however, modifications will be required due to the slow recruitment and poor adherence rates. LEVEL OF EVIDENCE: 1b: individualized randomized control trial.

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