Dosing Study of Massage for Neck Pain

October 11, 2017 updated by: Kaiser Permanente
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (Estimate)

May 13, 2010

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01AT004411-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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