Dosing Study of Massage for Neck Pain

This study is currently recruiting participants.
Verified by Group Health Cooperative, December 2010
First Received: May 11, 2010 Last Updated: December 27, 2010

Sponsor:
Group Health Cooperative
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01122836

Purpose
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.

Condition Intervention
Chronic Neck Pain Other: Massage

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Dose Comparison
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment Official Title: Dosing Study of Massage for Neck Pain

Further study details as provided by Group Health Cooperative: Primary Outcome Measures:

  • Improvement in neck related dysfunction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Evidence of clinically important improvement according to the Neck Pain Disability Index

  • Improvement in pain levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: July 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Massage Dose 1: Experimental
This arm receives weekly 60-minute massage for 4 weeks after a 4-week period of no treatment.
Intervention: Other: Massage

Other: Massage
Therapeutic Massage

 

Massage - Dose 2: Experimental
This arm receives weekly 60-minute massage for 4 weeks.
Intervention: Other: Massage

Other: Massage
Therapeutic Massage

 

Massage - Dose 3: Experimental
This arm receives 2 weekly 30-minute massage for 4 weeks.
Intervention: Other: Massage

Other: Massage
Therapeutic Massage

 

Massage - Dose 4: Experimental
This arm receives 2 weekly 60-minute massages for 4 weeks.
Intervention: Other: Massage

Other: Massage
Therapeutic Massage

 

Massage - Dose 5: Experimental
This arm receives 3 weekly 30-minute massages for 4 weeks.
Intervention: Other: Massage

Other: Massage
Therapeutic Massage

 

Massage - Dose 6: Experimental
This arm receives 3 weekly 60-minute massages for 4 weeks.
Intervention: Other: Massage

Other: Massage
Therapeutic Massage

 

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

Eligibility
Ages Eligible for Study: 20 Years to 64 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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

 

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