Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial

BMC Complementary and Alternative Medicine

Daniel C Cherkin²  Robert D Wellman⁴  Rene J Hawkes⁴  Janet R Kahn³  Andrea J Cook¹  Karen J Sherman⁵ 

[1] Department of Biostatistics, University of Washington, Seattle, WA, USA;Departments of Family Medicine and Health Services, University of Washington, Seattle, WA, USA;Department of Psychiatry, University of Vermont College of Medicine, Burlington, VT, USA;Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA, USA;Department of Epidemiology, University of Washington, Seattle, WA, USA

关键词: Chronic neck pain;    Optimal dose;    Therapeutic massage;   

Others  :  1232010
DOI  :  10.1186/1472-6882-12-158

 received in 2012-08-23, accepted in 2012-09-12,  发布年份 2012

【 摘 要 】

Background

Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment.

Methods/design

In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks.

Discussion

A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued.

Trial registration

This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836

【 授权许可】

   
2012 Sherman et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Makela M, Heliovaara M, Sievers K, Impivaara O, Knekt P, Aromaa A: Prevalence, determinants, and consequences of chronic neck pain in Finland. Am J Epidemiol 1991, 134:1356-1367.
• [2]Cote P, Cassidy JD, Carroll L: The Saskatchewan health and back pain survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine 1998, 23:1689-1698.
• [3]Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Cote P, Haldeman S, Ammendolia C, Carragee E, et al.: The burden and determinants of neck pain in the general population: results of the bone and joint decade 2000–2010 task force on neck pain and its associated disorders. Spine (Phila Pa 1976) 2008, 33:S39-S51.
• [4]Bovim G, Schrader H, Sand T: Neck pain in the general population. Spine 1994, 19:1307-1309.
• [5]Cote P, Cassidy JD, Carroll L: The treatment of neck and low back pain: who seeks care? who goes where? Med Care 2001, 39:956-967.
• [6]Goode AP, Freburger J, Carey T: Prevalence, practice patterns, and evidence for chronic neck pain. Arthritis Care Res (Hoboken) 2010, 62:1594-1601.
• [7]Panel P: Philadelphia panel evidence-based clinical practice guidelines on selected rehabilitation interventions for neck pain. Phys Ther 2001, 81:1701-1717.
• [8]Walter O, Spitzer C, Quebec Task Force on Spinal Disorders: Scientific approach to the assessment and management of activty-related spinal disorders: a monograph for clinicians - report of the quebec task force on spinal disorders. Spine 1987, 12(Suppl):S1-S59.
• [9]Borghouts JA, Koes BW, Vondeling H, Bouter LM: Cost-of-illness of neck pain in The Netherlands in 1996. Pain 1999, 80:629-636.
• [10]Aker PD, Gross AR, Goldsmith CH, Peloso P: Conservative management of mechanical neck pain: systematic overview and meta-analysis. BMJ 1996, 313:1291-1296.
• [11]Borenstein DG: Management of neck pain: a primary care approach. Hosp Pract 1998, 33:147-150.
• [12]Borghouts JA, Koes BW, Bouter LM: The clinical course and prognostic factors of non-specific neck pain: a systematic review. Pain 1998, 77:1-13.
• [13]Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S, et al.: Treatment of neck pain: noninvasive interventions: results of the bone and joint decade 2000–2010 task force on neck pain and its associated disorders. Spine (Phila Pa 1976) 2008, 33:S123-S152.
• [14]Barnes PM, Bloom B, Nahin RL: Complementary and alternative medicine use among adults and children: U.S., 2007. In Book complementary and alternative medicine use among adults and children: U.S., 2007. City: National Center for Health Statistics, U.S; 2008.
• [15]Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC: Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey. JAMA 1998, 280:1569-1575.
• [16]Coulter ID, Hurwitz EL, Adams AH, Genovese BJ, Hays R, Shekelle PG: Patients using chiropractors in North America: who are they, and why are they in chiropractic care? Spine 2002, 27:291-296. discussion 297–298
• [17]Cherkin DC, Deyo RA, Sherman KJ, Hart LG, Street JH, Hrbek A, Davis RB, Cramer E, Milliman B, Booker J, et al.: Characteristics of visits to licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians. J Am Board Fam Pract 2002, 15:463-472.
• [18]Haraldsson BG, Gross AR, Myers CD, Ezzo JM, Morien A, Goldsmith C, Peloso PM, Bronfort G: Massage for mechanical neck disorders. Cochrane Database Syst Rev 2006, 3:CD004871.
• [19]Brosseau L, Wells GA, Tugwell P, Casimiro L, Novikov M, Loew L, Sredic D, Clement S, Gravelle A, Hua K, et al.: Ottawa panel evidence-based clinical practice guidelines on therapeutic massage for neck pain. J Bodyw Mov Ther 2012, 16:300-325.
• [20]Sherman KJ, Cherkin DC, Hawkes RJ, Miglioretti DL, Deyo RA: Randomized trial of therapeutic massage for chronic neck pain. Clin J Pain 2009, 25:233-238.
• [21]Gross AR, Aker PD, Goldsmith CH, Peloso P: Patient education for mechanical neck disorders. Cochrane Database Syst Rev 2000, 2:CD000962.
• [22]Ware JEJ: SF-36 health survey update. Spine 2000, 25:3130-3139.
• [23]Vernon H, Mior S: The neck disability index: a study of reliability and validity. J Manipulative Physiol Ther 1991, 14:409-415.
• [24]Von Korff M, Jensen MP, Karoly P: Assessing global pain severity by self-report in clinical and health services research. Spine 2000, 25:3140-3151.
• [25]Riess P: Current estimates from the national health interview survey: United States, 1984. In Vital and health statistics. National Center for Health Statistics DHHS publication PHS 86–1584, Hyattsville; 1986. [10]
• [26]Bombardier C: Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine 2000, 25:3100-3103.
• [27]Cohen S, Williamson G: Perceived stress in a probability sample of the United States. In The social psychology of health: claremont symposium on applied social psychology. Edited by Spacapan S, Oskamp S. Sage, Newbury Park; 1988.
• [28]Cohen S, Kamarck T, Mermelstein R: A global measure of perceived stress. J Health Soc Behav 1983, 24:385-396.
• [29]Altmann DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Getzche P, Lang T: The revised CONSORT statement for reporting clinical trials: explanation and elaboration. Ann Intern Med 2001, 134:663-694.
• [30]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309.
• [31]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, 92:1634-1641.
• [32]Levin J, Serlin R, Seaman M: A controlled, powerful multiple-comparison strategy for several situaitons. Psychol Bull 1994, 115:153-159.
• [33]Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94:149-158.
• [34]Li QH: Evaluating co-primary endpoints collectively in clinical trials. Biom J 2009, 51:137-145.
• [35]Ruppert DWM, Carroll RJ: Semiparameteric Regression (Cambridge Series in Statistical and Probabilistic Mathematics). Cambridge, UK: Cambridge University Press; 2003.