title: The effect of massage therapy and/or exercise therapy on subacute or long-lasting neck pain--the Stockholm neck trial (STONE): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Neck pain is a major health problem in populations worldwide and an economic burden in modern societies due to its high prevalence and costs in terms of health care expenditures and lost productivity. Massage and exercise therapy are widely used management options for neck pain. However, there is a lack of scientific evidence regarding their effectiveness for subacute and long-lasting neck pain. This study protocol describes a randomized controlled trial aiming to determine the effect of massage and/or exercise therapy on subacute and long-lasting neck pain over the course of 1 year.
  
  
  METHODS
  A randomized controlled trial in which at least 600 study participants with subacute or long-lasting nonspecific neck pain will be recruited and randomly allocated to one of four treatment arms: massage therapy (A), exercise therapy (B), exercise therapy plus massage therapy (C) and advice to stay active (D). The study has an E-health approach, and study participants are being recruited through advertising with a mix of traditional and online marketing channels. Web-based self-report questionnaires measure the main outcomes at 7, 12, 26 and 52 weeks after inclusion. The primary outcomes are a clinically important improvement in pain intensity and pain-related disability at follow-up, measured with a modified version of the Chronic Pain Questionnaire (CPQ). The secondary outcomes are global improvement, health-related quality of life (EQ-5D), sick leave, drug consumption and healthcare utilization. Adverse events are measured by questionnaires at return visits to the clinic, and automated text messages (SMSes) survey neck pain intensity and pain-related disability every week over one year.
  
  
  CONCLUSIONS
  The results of this study will provide clinicians and stakeholders much needed knowledge to plan medical care for subacute and long-lasting neck pain disorders.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN01453590. Date of registration: 3 July 2014.
authors.affiliation: Musculoskeletal & Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-17177, Stockholm, Sweden. Eva.Skillgate@ki.se.|Naprapathögskolan, Scandinavian College of Naprapathic Manual Medicine, Kräftriket 23A, SE-11419, Stockholm, Sweden. Eva.Skillgate@ki.se.
authors.forename: Eva
authors.initials: E
authors.lastname: Skillgate
authors.affiliation: Musculoskeletal & Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-17177, Stockholm, Sweden. annesylviebill@gmail.com.
authors.forename: Anne-Sylvie
authors.initials: AS
authors.lastname: Bill
authors.affiliation: Dalla Lana School of Public Health, Division of Epidemiology, University of Toronto, Toronto, Ontario, Canada. pierre.cote@uoit.ca.|Faculty of Health Sciences, University of Ontario, Institute of Technology, UOIT-CMCC Centre for Disability Prevention and Rehabilitation, Oshawa, Ontario, Canada. pierre.cote@uoit.ca.
authors.forename: Pierre
authors.initials: P
authors.lastname: Côté
authors.affiliation: Naprapathögskolan, Scandinavian College of Naprapathic Manual Medicine, Kräftriket 23A, SE-11419, Stockholm, Sweden. peter.viklund@nph.se.
authors.forename: Peter
authors.initials: P
authors.lastname: Viklund
authors.affiliation: Musculoskeletal & Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-17177, Stockholm, Sweden. anna.peterson@ki.se.
authors.forename: Anna
authors.initials: A
authors.lastname: Peterson
authors.affiliation: Musculoskeletal & Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-17177, Stockholm, Sweden. lena.holm@ki.se.|Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. lena.holm@ki.se.
authors.forename: Lena W
authors.initials: LW
authors.lastname: Holm
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000191:economics; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008405:Massage / Q000191:economics; D008875:Middle Aged; D019547:Neck Pain / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D010147:Pain Measurement; D012107:Research Design; D011795:Surveys and Questionnaires; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult