Clinical trial NCT02218580: Massage Therapy in Juvenile Idiopathic Arthritis
Official title: Massage Therapy for Children With Juvenile Idiopathic Arthritis Experiencing Pain: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: massage therapy
juvenile arthritis
pain
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of JIA (ILAR classification)
* Age 5 to 17 years
* Ability to speak/read French or English; one caregiver per child will be recruited;
* Presence of pain, defined as: pain reported by the child and/or caregiver, and/or joint tenderness and/or stress pain in at least 1 joint during physical examination performed by rheumatologist. Pain reported by the child/caregiver is not a prerequisite because some children develop behaviors and guarding postures to avoid pain
* Absence of anticipated change in treatment. If, during the study, a change in treatment is necessary, the change will be recorded but the child will not be withdrawn
* Stable dosages of medications and absence of intra-articular corticosteroid injections for 4 weeks prior to enrolment
* Eligibility confirmed by child's rheumatologist.

Exclusion Criteria:

* No current MT
* Systemic arthritis with quotidian fevers
* Acute infection
* Open skin lesion
* Fibromyalgia
* Sleep apnea
* Medications: anticoagulants, muscle relaxants, analgesic medications (acetaminophen allowed)
* Pregnancy.

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 year
measure: Retention rate
timeFrame: 1 year
measure: Program adherence
timeFrame: 1 year
measure: Piloting the intervention
timeFrame: 1 year
measure: User acceptability and satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: Daily pain
timeFrame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group
measure: Daily fatigue
timeFrame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group
measure: Daily stiffness
timeFrame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group
measure: Daily sleep quality
timeFrame: Daily for 4 weeks for the intervention group and for 6 weeks for the control group
measure: Health-related Quality of Life (HRQOL)
timeFrame: 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).
measure: Fatigue
timeFrame: 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).
measure: Sleep quality
timeFrame: 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).
measure: Caregiver's psychological distress
timeFrame: 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).
measure: Disease activity
timeFrame: Disease activity will be evaluated before and after implementation of MT: on Day 1 and Day 29 for the intervention group; and on Day 1 and Day 44 for the control group.
Other outcomes:
measure: Levels of pro-inflammatory cytokines (IL-6, IL-17a, TNF)
timeFrame: Levels of pro-inflammatory cytokines will be evaluated before and after implementation of MT: on Day 1 and Day 29 for the intervention group; and on Day 1 and Day 44 for the control group.
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital - Glen site
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital of the MUHC
name: Sarah Campillo, MD
role: PRINCIPAL_INVESTIGATOR
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