ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 33 for:    Recruiting, Not yet recruiting, Available Studies | "Arthritis, Juvenile Rheumatoid"

Massage Therapy in Juvenile Idiopathic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02218580
Recruitment Status : Recruiting
First Posted : August 18, 2014
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah Campillo, McGill University Health Center

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.


Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Other: Massage therapy Other: Standard care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Massage Therapy for Children With Juvenile Idiopathic Arthritis Experiencing Pain: a Pilot Randomized Controlled Trial
Study Start Date : May 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Massage therapy & standard care

Massage therapy will be provided by caregiver for 15 minutes at bedtime at home, every night, for a 2-week period.

Standard care will include medications routinely prescribed in the treatment of JIA, physiotherapy and occupational therapy exercises, splints, warmth application and acetaminophen.

Other: Massage therapy
Other: Standard care
Active Comparator: Standard care
Standard care will include medications routinely prescribed in the treatment of JIA, physiotherapy and occupational therapy exercises, splints, warmth application and acetaminophen.
Other: Standard care



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. Disease activity [ Time Frame: 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. ]
    Disease activity will be evaluated with the active joint count (AJC) and the physician global assessment of disease activity (PGADA), obtained by physical examination performed by the rheumatologist. Disease activity will also be evaluated by the erythrocyte sedimentation rate (ESR) and the C-reactive protein (CRP), obtained by blood tests.


Other Outcome Measures:
  1. Levels of pro-inflammatory cytokines (IL-6, IL-17a, TNF) [ Time Frame: 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. ]
    The effects of MT on pro-inflammatory cytokines (IL-6, IL-17a, TNF) will be explored. Cytokines produced by stimulated cells isolated from whole blood will be measured by BD Cytometric Bead Array.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218580


Contacts
Contact: Sarah Campillo, MD 514-412-4400 ext 24268 sarah.campillo@muhc.mcgill.ca
Contact: Dorothy McKelvey 514-412-4400 ext 23833 dorothy.mckelvey@muhc.mcgill.ca

Locations
Canada, Quebec
Montreal Children's Hospital - Glen site Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Sarah Campillo, MD    514-412-4400 ext 24268    sarah.campillo@muhc.mcgill.ca   
Contact: Dorothy McKelvey    514-412-4400 ext 23833    dorothy.mckelvey@muhc.mcgill.ca   
Principal Investigator: Sarah Campillo, MD         
Sub-Investigator: Claire LeBlanc, MD         
Sub-Investigator: Rosie Scuccimarri, MD         
Sub-Investigator: Gaelle Chedeville, MD         
Sub-Investigator: Bruce Mazer, MD         
Sub-Investigator: Evelyn Constantin, MD         
Sub-Investigator: Charlene Hopper, N MSc         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Sarah Campillo, MD Montreal Children's Hospital of the MUHC

Publications:

Responsible Party: Sarah Campillo, Pediatric Rheumatologist, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02218580     History of Changes
Other Study ID Numbers: CRA (CIORA grant #4)
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Sarah Campillo, McGill University Health Center:
massage therapy
juvenile arthritis
pain

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases