Clinical Trial: Massage Therapy in Juvenile Idiopathic Arthritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 experim
Sponsor: McGill University Health Center

Current Primary Outcome:

• Recruitment rate [ Time Frame: 1 year ]
  Recruitment rate will be measured to evaluate the feasibility of a home MT program. The recruitment rate is defined as the proportion of patients recruited out of eligible patients.
• Retention rate [ Time Frame: 1 year ]
  Retention rate will be measured to evaluate the feasibility of a home MT program. Retention rate is defined as the proportion of patients who complete the MT program.
• Program adherence [ Time Frame: 1 year ]
  Program adherence will be measured to evaluate the feasibility of a home MT program. Program adherence is defined as the proportion of daily diaries completed by families.
• Piloting the intervention [ Time Frame: 1 year ]
  Suggestions for program improvement from massage therapist, research coordinator, nurse and investigators will be recorded, in order to evaluate the feasibility of a home MT program.
• User acceptability and satisfaction [ Time Frame: 1 year ]
  User acceptability and satisfaction will be evaluated to assess the feasibility of a home MT program. Caregivers will be asked to evaluate the helpfulness and ease of implementation of the program, provide suggestions for improvement, indicate whether they would recommend it to others.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Daily pain [ Time Frame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group ]
  Daily pain will be measured on 100 mm visual analogue scales (VAS) with the use of daily diaries, completed on a daily basis. Daily pain will be assessed in the evening. Caregivers and children over 8 years will complete VAS. All children will also complete the Faces Pain Scaled-Revised and will record painful locations on a body map. In the intervention group, the diaries will be completed every day, for a 2 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy. In the control group, the diaries will be completed every day, for a 4 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy.
• Daily fatigue [ Time Frame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group ]
  Daily fatigue will be measured on 100 mm VAS with the use of daily diaries, completed on a daily basis. Fatigue will be assessed in the evening. Caregivers and children over 8 years will complete VAS. In the intervention group, the diaries will be completed every day, for a 2 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy. In the control group, the diaries will be completed every day, for a 4 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy.
• Daily stiffness [ Time Frame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group ]
  Daily stiffness will be measured on 100mm VAS with the use of daily diaries, completed on a daily basis. Stiffness will be assessed in the evening. Caregivers and children over 8 years will complete VAS. In the intervention group, the diaries will be completed every day, for a 2 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy. In the control group, the diaries will be completed every day, for a 4 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy.
• Daily sleep quality [ Time Frame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group ]
  Daily sleep quality will be measured on 100mm VAS with the use of daily diaries, completed on a daily basis. Daily sleep quality will be assessed in the morning. Caregivers and children over 8 years will complete VAS. In the intervention group, the diaries will be completed every day, for a 2 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy. In the control group, the diaries will be completed every day, for a 4 week period before implementation of massage therapy, and for a 2 week period following implementation of massage therapy.
• Health-related Quality of Life (HRQOL) [ Time Frame: HRQOL will be measured three times during a 4 week period for the intervention group (Day 1, Day 15 and Day 29) and a 6 week period for the control group (Day 1, Day 30 and Day 44). ]
  HRQOL will be measured by questionnaires, using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and the PedsQL 3.0 Rheumatology module. Both caregivers and children will complete the questionnaires, at 3 time points (before implementation of MT, on the MT training day and after implementation of MT).
• Fatigue [ Time Frame: Fatigue will be measured three times during a 4 week period for the intervention group (Day 1, Day 15 and Day 29) and a 6 week period for the control group (Day 1, Day 30 and Day 44). ]
  Fatigue will be measured by a questionnaire, using the PedsQL Multidimensional Fatigue Scale. Both caregivers and children will complete the questionnaire, at 3 time points (before implementation of MT, on the MT training day and after implementation of MT).
• Sleep quality [ Time Frame: Sleep quality will be measured three times during a 4 week period for the intervention group (Day 1, Day 15 and Day 29) and a 6 week period for the control group (Day 1, Day 30 and Day 44). ]
  Sleep quality will be measured by a questionnaire, using the Sleep Disturbance Scale for Children. Caregivers will complete this questionnaire, at 3 time points (before implementation of MT, on the MT training day and after implementation of MT).
• Caregiver's psychological distress [ Time Frame: Caregiver's psychological distress will be measured three times during a 4 week period for the intervention group (Day 1, Day 15 and Day 29) and a 6 week period for the control group (Day 1, Day 30 and Day 44). ]
  Caregiver's psychological distress will be measured by a questionnaire, using the Symptom Checklist-90-Revised. Caregivers will complete this questionnaire, at 3 time points (before implementation of MT, on the MT training day and after implementation of MT).
• Disease activity [ Time Frame: Disease activity will be
  
  

  Original Secondary Outcome: Same as current
  
  Information By: McGill University Health Center
  

  Dates:
  Date Received: July 7, 2014
  Date Started: May 2015
  Date Completion: December 2017
  Last Updated: September 12, 2016
  Last Verified: September 2016