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Dosing Study of Massage for Neck Pain

NCT ID: NCT01122836

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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

Conditions

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Chronic Neck Pain

Keywords

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Massage Chronic Neck Pain Dosing Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Massage Dose 1

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

Group Type EXPERIMENTAL

Massage

Intervention Type OTHER

Therapeutic Massage

Massage - Dose 2

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

Group Type EXPERIMENTAL

Massage

Intervention Type OTHER

Therapeutic Massage

Massage - Dose 3

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

Group Type EXPERIMENTAL

Massage

Intervention Type OTHER

Therapeutic Massage

Massage - Dose 4

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

Group Type EXPERIMENTAL

Massage

Intervention Type OTHER

Therapeutic Massage

Massage - Dose 5

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

Group Type EXPERIMENTAL

Massage

Intervention Type OTHER

Therapeutic Massage

Massage - Dose 6

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

Group Type EXPERIMENTAL

Massage

Intervention Type OTHER

Therapeutic Massage

Interventions

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Massage

Therapeutic Massage

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen J Sherman, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26096474 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22985134 (View on PubMed)

Other Identifiers

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5R01AT004411-02

Identifier Type: NIH

Identifier Source: org_study_id

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