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Dosing Study of Massage for Neck Pain

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

Tracking Information
First Submitted Date  ICMJE May 11, 2010
First Posted Date  ICMJE May 13, 2010
Last Update Posted Date October 13, 2017
Study Start Date  ICMJE July 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosing Study of Massage for Neck Pain
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Neck Pain
Intervention  ICMJE Other: Massage
Therapeutic Massage
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 11, 2010)
228
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01122836
Other Study ID Numbers  ICMJE 5R01AT004411-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Karen J Sherman, MPH, PhD Group Health Research Institute
PRS Account Kaiser Permanente
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP