Dosing Study of Massage for Neck Pain

• ClinicalTrials.gov Identifier: NCT01122836
• Recruitment Status: Completed
• First Posted: May 13, 2010
• Last Update Posted: October 13, 2017
• Sponsor: Kaiser Permanente
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Kaiser Permanente

Tracking Information

• First Submitted Date: May 11, 2010
• First Posted Date: May 13, 2010
• Last Update Posted Date: October 13, 2017
• Study Start Date: July 2010
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2010)

• Improvement in neck related dysfunction [ Time Frame: 4 weeks ]
  Evidence of clinically important improvement according to the Neck Pain Disability Index
• Improvement in pain levels [ Time Frame: 4 weeks ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dosing Study of Massage for Neck Pain
• Official Title: Dosing Study of Massage for Neck Pain
• Brief Summary: This study is designed to determine the most effective dose of massage for persons with chronic neck pain. This information is necessary before more definitive studies can be conducted.
• Detailed Description: This study's long-term objective is to identify effective treatments for with neck pain. Many Americans have found conventional medical treatments ineffective for this common and costly problem and are increasingly trying complementary and alternative treatments, including therapeutic massage. Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research in this area. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the numbers of minutes per massage session, sessions per weeks, 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. In this project, 228 persons with chronic non-specific neck pain 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-minute treatments per week or 1, 2, or 3 60-minute 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-minute massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 4, 10, and 26 weeks post-randomization. To better characterize the trajectory of the persistence of treatment effects, these interview data will be supplemented with outcomes data collected by mailed questionnaire at 8, 14, 18 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. The results of this study will: 1) guide the development of a massage treatment protocol to be used in a full-scale trial evaluating the effectiveness of therapeutic massage for chronic neck pain, 2) serve as a model for future dosing studies of massage and bodywork, and 3) help interpret the adequacy of the dosing of massage used in past studies of massage for neck pain
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Neck Pain

Intervention

Other: Massage

Therapeutic Massage

Study Arms

• Experimental: Massage Dose 1
  This arm receives weekly 60-minute massage for 4 weeks after a 4-week period of no treatment.
  Intervention: Other: Massage
• Experimental: Massage - Dose 2
  This arm receives weekly 60-minute massage for 4 weeks.
  Intervention: Other: Massage
• Experimental: Massage - Dose 3
  This arm receives 2 weekly 30-minute massage for 4 weeks.
  Intervention: Other: Massage
• Experimental: Massage - Dose 4
  This arm receives 2 weekly 60-minute massages for 4 weeks.
  Intervention: Other: Massage
• Experimental: Massage - Dose 5
  This arm receives 3 weekly 30-minute massages for 4 weeks.
  Intervention: Other: Massage
• Experimental: Massage - Dose 6
  This arm receives 3 weekly 60-minute massages for 4 weeks.
  Intervention: Other: Massage

Publications *

• Cook AJ, Wellman RD, Cherkin DC, Kahn JR, Sherman KJ. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes. Spine J. 2015 Oct 1;15(10):2206-15. doi: 10.1016/j.spinee.2015.06.049. Epub 2015 Jun 19.
• Sherman KJ, Cook AJ, Kahn JR, Hawkes RJ, Wellman RD, Cherkin DC. Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial. BMC Complement Altern Med. 2012 Sep 18;12:158. doi: 10.1186/1472-6882-12-158.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: May 11, 2010): 228
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Symptoms consistent with non-specific, uncomplicated neck pain of at least moderate level of pain
• Lives or works within Greater Seattle WA geographic area

Exclusion Criteria:

• Cervical Radiculopathy
• History of cancer (other than nonmelanoma skin cancer)
• Severe disk problems
• Unstable medical conditions
• Previous neck surgery
• Physically unable to get on and off of a massage table
• Has had massage within the last year
• Currently in litigation for neck pain
• Seeking other treatment for neck pain
• Potential contraindications for massage
• Unable to give informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01122836
• Other Study ID Numbers: 5R01AT004411-02( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kaiser Permanente
• Original Responsible Party: Karen J Sherman, MPH, PhD, Group Health Research Institute
• Current Study Sponsor: Kaiser Permanente
• Original Study Sponsor: Same as current
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Karen J Sherman, MPH, PhD; Group Health Research Institute

• PRS Account: Kaiser Permanente
• Verification Date: October 2017