Massage Therapy in Juvenile Idiopathic Arthritis

NCT02218580 | Terminated

• 1 other identifier: CRA (CIORA grant #4)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

massage therapy; juvenile arthritis; pain

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  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.

  1 year

• Retention rate

  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.

  1 year

• Program adherence

  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.

  1 year

• Piloting the intervention

  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.

  1 year

• User acceptability and satisfaction

  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.

  1 year

Secondary Outcomes (9)

• Daily pain

  Daily for 4 weeks for the intervention group and for 6 weeks for the control group

• Daily fatigue

  Daily for 4 weeks for the intervention group and for 6 weeks for the control group

• Daily stiffness

  Daily for 4 weeks for the intervention group and for 6 weeks for the control group

• Daily sleep quality

  Daily for 4 weeks for the intervention group and for 6 weeks for the control group

• Health-related Quality of Life (HRQOL)

  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).

Other Outcomes (1)

• Levels of pro-inflammatory cytokines (IL-6, IL-17a, TNF)

  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.

Study Arms (2)

Massage therapy & standard care

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

Massage therapy OTHER

Massage therapy & standard care

Standard care OTHER

Massage therapy & standard care; Standard care

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal Children's Hospital - Glen site

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (18)

• Bromberg MH, Connelly M, Anthony KK, Gil KM, Schanberg LE. Self-reported pain and disease symptoms persist in juvenile idiopathic arthritis despite treatment advances: an electronic diary study. Arthritis Rheumatol. 2014 Feb;66(2):462-9. doi: 10.1002/art.38223.

  PMID: 24504820 BACKGROUND

• Schanberg LE, Anthony KK, Gil KM, Maurin EC. Daily pain and symptoms in children with polyarticular arthritis. Arthritis Rheum. 2003 May;48(5):1390-7. doi: 10.1002/art.10986.

  PMID: 12746912 BACKGROUND

• Schanberg LE, Gil KM, Anthony KK, Yow E, Rochon J. Pain, stiffness, and fatigue in juvenile polyarticular arthritis: contemporaneous stressful events and mood as predictors. Arthritis Rheum. 2005 Apr;52(4):1196-204. doi: 10.1002/art.20952.

  PMID: 15818661 BACKGROUND

• Bloom BJ, Owens JA, McGuinn M, Nobile C, Schaeffer L, Alario AJ. Sleep and its relationship to pain, dysfunction, and disease activity in juvenile rheumatoid arthritis. J Rheumatol. 2002 Jan;29(1):169-73.

  PMID: 11824956 BACKGROUND

• Passarelli CM, Roizenblatt S, Len CA, Moreira GA, Lopes MC, Guilleminault C, Tufik S, Hilario MO. A case-control sleep study in children with polyarticular juvenile rheumatoid arthritis. J Rheumatol. 2006 Apr;33(4):796-802. Epub 2006 Mar 1.

  PMID: 16511937 BACKGROUND

• Oliveira S, Ravelli A, Pistorio A, Castell E, Malattia C, Prieur AM, Saad-Magalhaes C, Murray KJ, Bae SC, Joos R, Foeldvari I, Duarte-Salazar C, Wulffraat N, Lahdenne P, Dolezalova P, de Inocencio J, Kanakoudi-Tsakalidou F, Hofer M, Nikishina I, Ozdogan H, Hashkes PJ, Landgraf JM, Martini A, Ruperto N; Pediatric Rheumatology International Trials Organization (PRINTO). Proxy-reported health-related quality of life of patients with juvenile idiopathic arthritis: the Pediatric Rheumatology International Trials Organization multinational quality of life cohort study. Arthritis Rheum. 2007 Feb 15;57(1):35-43. doi: 10.1002/art.22473.

  PMID: 17266064 BACKGROUND

• Shaw KL, Southwood TR, McDonagh JE. Growing up and moving on in rheumatology: parents as proxies of adolescents with juvenile idiopathic arthritis. Arthritis Rheum. 2006 Apr 15;55(2):189-98. doi: 10.1002/art.21834.

  PMID: 16583398 BACKGROUND

• April KT, Feldman DE, Zunzunegui MV, Descarreaux M, Malleson P, Duffy CM. Longitudinal analysis of complementary and alternative health care use in children with juvenile idiopathic arthritis. Complement Ther Med. 2009 Aug;17(4):208-15. doi: 10.1016/j.ctim.2009.03.003. Epub 2009 May 1.

  PMID: 19632548 BACKGROUND

• van Tulder MW, Furlan AD, Gagnier JJ. Complementary and alternative therapies for low back pain. Best Pract Res Clin Rheumatol. 2005 Aug;19(4):639-54. doi: 10.1016/j.berh.2005.03.006.

  PMID: 15949781 BACKGROUND

• Kalichman L. Massage therapy for fibromyalgia symptoms. Rheumatol Int. 2010 Jul;30(9):1151-7. doi: 10.1007/s00296-010-1409-2. Epub 2010 Mar 20.

  PMID: 20306046 BACKGROUND

• Bender T, Nagy G, Barna I, Tefner I, Kadas E, Geher P. The effect of physical therapy on beta-endorphin levels. Eur J Appl Physiol. 2007 Jul;100(4):371-82. doi: 10.1007/s00421-007-0469-9. Epub 2007 May 5.

  PMID: 17483960 BACKGROUND

• Sunshine W, Field TM, Quintino O, Fierro K, Kuhn C, Burman I, Schanberg S. Fibromyalgia benefits from massage therapy and transcutaneous electrical stimulation. J Clin Rheumatol. 1996 Feb;2(1):18-22. doi: 10.1097/00124743-199602000-00005.

  PMID: 19078022 BACKGROUND

• Diego MA, Field T, Hernandez-Reif M, Shaw K, Friedman L, Ironson G. HIV adolescents show improved immune function following massage therapy. Int J Neurosci. 2001 Jan;106(1-2):35-45. doi: 10.3109/00207450109149736.

  PMID: 11264907 BACKGROUND

• Field T, Morrow C, Valdeon C, Larson S, Kuhn C, Schanberg S. Massage reduces anxiety in child and adolescent psychiatric patients. J Am Acad Child Adolesc Psychiatry. 1992 Jan;31(1):125-31. doi: 10.1097/00004583-199201000-00019.

  PMID: 1537763 BACKGROUND

• Field T, Henteleff T, Hernandez-Reif M, Martinez E, Mavunda K, Kuhn C, Schanberg S. Children with asthma have improved pulmonary functions after massage therapy. J Pediatr. 1998 May;132(5):854-8. doi: 10.1016/s0022-3476(98)70317-8.

  PMID: 9602199 BACKGROUND

• Hart S, Field T, Hernandez-Reif M, Nearing G, Shaw S, Schanberg S, Kuhn C. Anorexia nervosa symptoms are reduced by massage therapy. Eat Disord. 2001 Winter;9(4):289-99. doi: 10.1080/106402601753454868.

  PMID: 16864390 BACKGROUND

• Field T, Hernandez-Reif M, Seligman S, Krasnegor J, Sunshine W, Rivas-Chacon R, Schanberg S, Kuhn C. Juvenile rheumatoid arthritis: benefits from massage therapy. J Pediatr Psychol. 1997 Oct;22(5):607-17. doi: 10.1093/jpepsy/22.5.607.

  PMID: 9383925 BACKGROUND

• Field T. Massage therapy for infants and children. J Dev Behav Pediatr. 1995 Apr;16(2):105-11.

  PMID: 7790516 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile; Pain

Interventions

Massage; Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah Campillo, MD

  Montreal Children's Hospital of the MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Rheumatologist, Assistant Professor

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: August 18, 2014
• Study Start: May 1, 2015
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

CA (1)