Massage Therapy in Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

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

Status Terminated

Clinical Trial Summary

While there has been progress in juvenile idiopathic arthritis (JIA) management, there is no cure. Despite receiving standard of care, many children live with pain. Thus, it is not surprising that families turn to complementary and alternative medicines (CAM) therapies, including massage therapy (MT). Little is known about the efficacy of MT in JIA.

In this project, a massage therapist will teach parents how to provide a massage to their child with JIA at bedtime, at home. The feasibility of establishing a home MT program for children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined.

This proposal is relevant to JIA families, who ask questions on MT to professionals of the JIA clinic.

Beyond providing education to JIA families, this project demonstrates the team approach to JIA management. Team members will include a pediatric rheumatology nurse and a massage therapist.

Clinical Trial Description

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.

Conclusion The findings from this project will provide the framework for planning a multi-center study whose focus will be on the efficacy of MT in JIA. MT programs do not exist in Canadian pediatric rheumatology centres and thus, this project is innovative. If there is preliminary evidence that MT helps reduce pain, it could become an additional strategy to help these children have a better HRQoL, with less pain and improved health outcomes. Parents could feel empowered by participating concretely and in a positive way in the management of their child's condition. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

• NCT number: NCT02218580
• Study type: Interventional
• Source: McGill University Health Center
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Completion date: March 26, 2019