期刊论文详细信息
BMC Musculoskeletal Disorders
Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial
Eva Skillgate2  Jessica Lyander2  Martin Asker2  Margareta Nordin1  Lena W Holm3  Kari Paanalahti2 
[1]Occupational and Industrial Orthopaedic Center (OIOC), NYU Hospital for Joint Diseases, New York University Langone Medical Center, 63 Downing Street, New York, NY 10014, USA
[2]Scandinavian College of Naprapathic Manual Medicine, Kräftriket 23A, SE-11419 Stockholm, Sweden
[3]Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-17177 Stockholm, Sweden
关键词: RCT;    Adverse event;    Manual therapy;    Naprapathy;   
Others  :  1128678
DOI  :  10.1186/1471-2474-15-77
 received in 2013-10-29, accepted in 2014-02-25,  发布年份 2014
PDF
【 摘 要 】

Background

The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy. The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain. In addition women and men were compared regarding the occurrence of adverse events.

Methods

Participants were recruited among patients, ages 18–65, seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 767) were randomized to one of three treatment arms 1) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249), 2) manual therapy excluding spinal manipulation (n = 258) and 3) manual therapy excluding stretching (n = 260). Treatments were provided by students in the seventh semester of total eight. Adverse events were measured with a questionnaire after each return visit and categorized in to five levels; 1) short minor, 2) long minor, 3) short moderate, 4) long moderate and 5) serious adverse events, based on the duration and/or severity of the event. Generalized estimating equations were used to examine the association between adverse event and treatments arms.

Results

The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events (OR = 2.19 (95% CI: 1.52-3.15)), and long moderate adverse events (OR = 2.49 (95% CI: 1.77-3.52)) compared to men.

Conclusion

Adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men.

Trial registration

This trial was registered in a public registry (Current Controlled Trials) (ISRCTN92249294).

【 授权许可】

   
2014 Paanalahti et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20150225034532320.pdf 264KB PDF download
Figure 1. 58KB Image download
【 图 表 】

Figure 1.

【 参考文献 】
  • [1]Demyttenaere K, Bruffaerts R, Lee S, Posada-Villa J, Kovess V, Angermeyer MC, Levinson D, de Girolamo G, Nakane H, Mneimneh Z, Lara C, de Graaf R, Scott KM, Gureje O, Stein DJ, Haro JM, Bromet EJ, Kessler RC, Alonso J, Von Korff M: Mental disorders among persons with chronic back or neck pain: results from the World Mental Health Surveys. Pain 2007, 129(3):332-342.
  • [2]Manchikanti L, Singh V, Datta S, Cohen SP, Hirsch JA: Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician 2009, 12(4):E35-70.
  • [3]Koes BW, van Tulder MW, Ostelo R, Kim Burton A, Waddell G: Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine (Phila Pa 1976) 2001, 26(22):2504-2513. discussion 2513–2504
  • [4]Paciaroni M, Bogousslavsky J: Cerebrovascular complications of neck manipulation. Eur Neurol 2009, 61(2):112-118.
  • [5]Ernst E: Adverse effects of spinal manipulation: a systematic review. J R Soc Med 2007, 100(7):330-338.
  • [6]Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM: Adverse reactions to chiropractic treatment and their effects on satisfaction and clinical outcomes among patients enrolled in the UCLA Neck Pain Study. J Manipulative Physiol Ther 2004, 27(1):16-25.
  • [7]Eriksen K, Rochester RP, Hurwitz EL: Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: a prospective, multicenter, cohort study. BMC Musculoskelet Disord 2011, 12:219. BioMed Central Full Text
  • [8]Carnes D, Mars TS, Mullinger B, Froud R, Underwood M: Adverse events and manual therapy: a systematic review. Man Ther 2010, 15(4):355-363.
  • [9]Cassidy JD, Boyle E, Cote P, He Y, Hogg-Johnson S, Silver FL, Bondy SJ: Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case–control and case-crossover study. Spine (Phila Pa 1976) 2008, 33(4 Suppl):S176-S183.
  • [10]Gouveia LO, Castanho P, Ferreira JJ: Safety of chiropractic interventions: a systematic review. Spine (Phila Pa 1976) 2009, 34(11):E405-413.
  • [11]Choi S, Boyle E, Cote P, Cassidy JD: A population-based case-series of Ontario patients who develop a vertebrobasilar artery stroke after seeing a chiropractor. J Manipulative Physiol Ther 2011, 34(1):15-22.
  • [12]Hurwitz EL, Morgenstern H, Harber P, Kominski GF, Yu F, Adams AH: A randomized trial of chiropractic manipulation and mobilization for patients with neck pain: clinical outcomes from the UCLA neck-pain study. Am J Public Health 2002, 92(10):1634-1641.
  • [13]Gross AR, Hoving JL, Haines TA, Goldsmith CH, Kay T, Aker P, Bronfort G: A Cochrane review of manipulation and mobilization for mechanical neck disorders. Spine (Phila Pa 1976) 2004, 29(14):1541-1548.
  • [14]Hakkinen A, Salo P, Tarvainen U, Wiren K, Ylinen J: Effect of manual therapy and stretching on neck muscle strength and mobility in chronic neck pain. J Rehabil Med 2007, 39(7):575-579.
  • [15]da Costa BR, Vieira ER: Stretching to reduce work-related musculoskeletal disorders: a systematic review. J Rehabil Med 2008, 40(5):321-328.
  • [16]Cagnie B, Vinck E, Beernaert A, Cambier D: How common are side effects of spinal manipulation and can these side effects be predicted? Man Ther 2004, 9(3):151-156.
  • [17]Skillgate E, Vingard E, Alfredsson L: Naprapathic manual therapy or evidence-based care for back and neck pain: a randomized, controlled trial. Clin J Pain 2007, 23(5):431-439.
  • [18]Key W: Författningshandbok för personal inom hälso- och sjukvården. Stockholm: Liber; 2004:64-68.
  • [19]Skillgate E, Vingard E, Josephson M, Theorell T, Alfredsson L: Life events and the risk of low back and neck/shoulder pain of the kind people are seeking care for: results from the MUSIC-Norrtalje case–control study. J Epidemiol Community Health 2007, 61(4):356-361.
  • [20]Ware J Jr, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34(3):220-233.
  • [21]von Korff M, Ormel J, Keefe FJ, Dworkin SF: Grading the severity of chronic pain. Pain 1992, 50(2):133-149.
  • [22]Senstad O, Leboeuf-Yde C, Borchgrevink C: Frequency and characteristics of side effects of spinal manipulative therapy. Spine (Phila Pa 1976) 1997, 22(4):435-440. discussion 440–431
  • [23]Barrett AJ, Breen AC: Adverse effects of spinal manipulation. J R Soc Med 2000, 93(5):258-259.
  • [24]Rubinstein SM, Leboeuf-Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW: The benefits outweigh the risks for patients undergoing chiropractic care for neck pain: a prospective, multicenter, cohort study. J Manipulative Physiol Ther 2007, 30(6):408-418.
  • [25]Hoogendoorn WE, Bongers PM, de Vet HC, Twisk JW, van Mechelen W, Bouter LM: Comparison of two different approaches for the analysis of data from a prospective cohort study: an application to work related risk factors for low back pain. Occup Environ Med 2002, 59(7):459-465.
  • [26]Zeger SL, Liang KY: Longitudinal data analysis for discrete and continuous outcomes. Biometrics 1986, 42(1):121-130.
  • [27]StataCorp: Stata Statistical Software: Release 12. College Station, TX: StataCorp LP; 2011.
  • [28]Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH: Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial. Ann Intern Med 2012, 156(1 Pt 1):1-10.
  • [29]Leaver AM, Maher CG, Herbert RD, Latimer J, McAuley JH, Jull G, Refshauge KM: A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain. Arch Phys Med Rehabil 2010, 91(9):1313-1318.
  • [30]Hondras MA, Long CR, Cao Y, Rowell RM, Meeker WC: A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain. J Manipulative Physiol Ther 2009, 32(5):330-343.
  • [31]Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM: Frequency and clinical predictors of adverse reactions to chiropractic care in the UCLA neck pain study. Spine (Phila Pa 1976) 2005, 30(13):1477-1484.
  文献评价指标  
  下载次数:10次 浏览次数:4次