Laser Therapy for Lymphedema: Feasibility Trial

INTERVENTION: For those participants randomized to receive Low Level Laser Therapy (LLLT), in addition to usual care as described below, participants will receive 12 sessions of LLLT over a six‐week period (twice per week) at the School of Physiotherapy Clinic, University of Otago. Treatment will be performed by a trained registered physiotherapist (Lesley Inglis (LI)) holding a current practising certificate. LI has forty years clinical experience in Physiotherapy (expertise in rehabilitation, neurobiology, and management of musculoskeletal disorders), and two years clinical experience in using LLLT to treat patients with musculoskeletal disorders. The parameters for laser therapy treatment are standardised as follows: wavelength 980/810nm (80:20 ratio); output power 500mW; treatment head of 5cm2; irradiance of 100mW/cm2; treatment time per area 1 minute; dosage per area treated 30J (6J/cm2); 10 points of treatment from axilla to wrist; total laser therapy treatment time of 10 minutes; total dosage delivered 300J. A total of 12 treatments will be performed, twice weekly, across a six week period. The latter may be extended to ensure all 12 treatments are provided. LI will be present throughout the treatment, and monitor the participant’s response to LLLT. All the costs relevant to the treatment (e.g. therapist consultation, treatment materials and administration) will be covered by the funding support. CONDITION: Breast Cancer‐Related Lymphedema PRIMARY OUTCOME: Acceptability of the LLLT treatment to participants who are randomized into the usual care plus LLLT group ; i. Number of treatment sessions attended (measured by review of participant's treatment log) ; ii. Frequency of treatment sessions attended per week (measured by review of participant's treatment log) ; iii. Reasons for non‐attendance or early withdraw from treatment (measured by review of participant's treatment log) ; iv. Adherence to treatment protocol (measured by review of participant's treatment log) ; v. Participants feedback on the LLLT treatment: for those participants receive LLLT in addition to usual care for lymphedema, a questionnaire of seven separate questions about participant’s impressions and comments on LLLT treatment will be obtained. Feasibility of the recruitment process ; i. Number of participants showing interest in joining the trial ; ii. Number of participants eligible after completing telephone screening ; iii. Number of participants willing to be randomized into the trial from amongst those eligible ; iv. Reasons for non‐participation and ineligibility ; Follow‐up rates (measured by review of research assistant's study follow‐up log) INCLUSION CRITERIA: Participants are eligible if they (1) are women over 18 years old; (2) are referred/attending for breast cancer‐related lymphedema treatment at the Department of Physiotherapy in Dunedin Hospital; (3) are able to communicate in English/Mandarin. SECONDARY OUTCOME: Activity disability: difficulty for doing specific daily activities due to lymphedema over the past week (i.e. put on bra, tie shoes, wash hair, and hang out washing) will be scored from 0 (no difficulty) to 10 (most difficulty ever). Limb circumference: limb circumference will be measured using a tape measure at five anatomical based points on both arms, including 10cm and 20cm proximal to and 10cm distal to the antecubital fossa, ulnar styloid, and web space. Differences between both arms at each anatomical point will be recorded as delta circumference (delta C): delta C0 at baseline, delta C6 at 6 weeks post randomization, and delta C12 at 12 weeks post randomization. Perceptual symptoms: participant’s perceptual pain and heaviness in the affected limb over the past week will be self‐assessed by two 10‐cm Visual Analogue Scale (VAS) scales, where 0 represent no pain/heaviness and 10 are the worst imaginable pain/heaviness ever. Psychological impacts: participants will be asked to rate the impact of lymphedema on their psychological wellbeing over the past week (e.g. self‐consciousness, perception of symptoms, anxiety, and emotions). Response for each item will range from 0 – 10, where 0 indicates ‘not at all affect’ and 10 ‘extremely affect’. Scores for each item will be summed for the total score of psychological impacts.