Massage Therapy for Children With Juvenile Idiopathic Arthritis Experiencing Pain: a Pilot Randomized Controlled Trial

While research breakthroughs have led to improved outcomes, many patients with JIA live with pain. There is an association between daily fluctuations in JIA symptoms (pain, stiffness and fatigue), and worse mood and stressful events, supporting the utility of daily diaries to analyze JIA symptoms. Sleep disturbances have been demonstrated in JIA and are linked to the pain experience. Ultimately, pain impacts on HRQoL. JIA families explore complementary and alternative medicines such as MT, in addition to using conventional medicines, to help manage the daily JIA symptoms. MT's effects on pain, mood, anxiety, stress and sleep have been demonstrated in several diseases, possibly through modulation of neurological, endocrine and immune processes. Children with JIA and pain could benefit from MT given with standard care. Only one study evaluated its benefits in JIA. More research is needed on the feasibility, efficacy and safety of MT in JIA. MT is available at the Montreal Children's Hospital in Oncology. While offering MT in the hospital setting is practical for oncology patients who require frequent hospitalizations, MT may be more beneficial for JIA patients if implemented at home.

Objectives The primary purpose of this single center, pilot randomized controlled trial (pilot RCT) is to determine the feasibility of a home MT program for children with JIA experiencing pain. The second purpose is to determine the effects of MT primarily on daily pain, as well as, other daily JIA symptoms (stiffness and fatigue), sleep quality, health-related quality of life (HRQoL) and disease activity, and on caregiver's psychological distress. The effects of MT on pro-inflammatory cytokines (IL-6, 17A, TNF) will be explored.

Methodology During the pilot RCT (Part 1), 30 children with JIA who experience pain will be randomized to the experimental group (home MT and standard care) or control group (standard care). After receiving training by the massage therapist, caregivers of the experimental group will gently massage their child, for 15 minutes at bedtime, every night, at home. Immediately after the RCT, participants of the control group will receive training and implement home MT, similar to the experimental group, in an extension (Part 2).

Feasibility will be evaluated by the recruitment rate, retention rate, program adherence, piloting of the intervention, and user acceptability and satisfaction with the program.

Given the daily fluctuations in JIA symptoms, daily pain, fatigue, stiffness and sleep quality will be evaluated through multiple measurements with daily diaries to be completed by patients and their caregivers, both before and after implementation of home MT in both groups. Sleep, fatigue, HRQoL, disease activity and caregiver's psychological distress will also be evaluated before and after implementation of home MT in both groups, with questionnaires, physical examinations and blood samples.