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Completed

NCT Number: NCT01122836

Dosing Study of Massage for Neck Pain

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.

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Key information

Conditions

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Health Research Institute

Seattle, Washington, 98101, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage

Other

Therapeutic Massage

Primary outcomes

  1. Improvement in neck related dysfunction

    Time frame: 4 weeks

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

  2. Improvement in pain levels

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
May 13, 2010
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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