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Dosing Study of Massage for Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Massage, Chronic Neck Pain, Dosing Study

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Massage Dose 1

Massage - Dose 2

Massage - Dose 3

Massage - Dose 4

Massage - Dose 5

Massage - Dose 6

Arm Description

This arm receives weekly 60-minute massage for 4 weeks after a 4-week period of no treatment.

This arm receives weekly 60-minute massage for 4 weeks.

This arm receives 2 weekly 30-minute massage for 4 weeks.

This arm receives 2 weekly 60-minute massages for 4 weeks.

This arm receives 3 weekly 30-minute massages for 4 weeks.

This arm receives 3 weekly 60-minute massages for 4 weeks.

Outcomes

Primary Outcome Measures

Improvement in neck related dysfunction
Evidence of clinically important improvement according to the Neck Pain Disability Index
Improvement in pain levels

Secondary Outcome Measures

Full Information

First Posted
May 11, 2010
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01122836
Brief Title
Dosing Study of Massage for Neck Pain
Official Title
Dosing Study of Massage for Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Massage, Chronic Neck Pain, Dosing Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massage Dose 1
Arm Type
Experimental
Arm Description
This arm receives weekly 60-minute massage for 4 weeks after a 4-week period of no treatment.
Arm Title
Massage - Dose 2
Arm Type
Experimental
Arm Description
This arm receives weekly 60-minute massage for 4 weeks.
Arm Title
Massage - Dose 3
Arm Type
Experimental
Arm Description
This arm receives 2 weekly 30-minute massage for 4 weeks.
Arm Title
Massage - Dose 4
Arm Type
Experimental
Arm Description
This arm receives 2 weekly 60-minute massages for 4 weeks.
Arm Title
Massage - Dose 5
Arm Type
Experimental
Arm Description
This arm receives 3 weekly 30-minute massages for 4 weeks.
Arm Title
Massage - Dose 6
Arm Type
Experimental
Arm Description
This arm receives 3 weekly 60-minute massages for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
Therapeutic Massage
Primary Outcome Measure Information:
Title
Improvement in neck related dysfunction
Description
Evidence of clinically important improvement according to the Neck Pain Disability Index
Time Frame
4 weeks
Title
Improvement in pain levels
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J Sherman, MPH, PhD
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26096474
Citation
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.
Results Reference
derived
PubMed Identifier
22985134
Citation
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.
Results Reference
derived

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Dosing Study of Massage for Neck Pain

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