NCT01122836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

May 11, 2010

Last Update Submit

October 11, 2017

Conditions

Keywords

MassageChronic Neck PainDosing Study

Outcome Measures

Primary Outcomes (2)

  • Improvement in neck related dysfunction

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

    4 weeks

  • Improvement in pain levels

    4 weeks

Study Arms (6)

Massage Dose 1

EXPERIMENTAL

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

Other: Massage

Massage - Dose 2

EXPERIMENTAL

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

Other: Massage

Massage - Dose 3

EXPERIMENTAL

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

Other: Massage

Massage - Dose 4

EXPERIMENTAL

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

Other: Massage

Massage - Dose 5

EXPERIMENTAL

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

Other: Massage

Massage - Dose 6

EXPERIMENTAL

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

Other: Massage

Interventions

MassageOTHER

Therapeutic Massage

Massage - Dose 2Massage - Dose 3Massage - Dose 4Massage - Dose 5Massage - Dose 6Massage Dose 1

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptoms consistent with non-specific, uncomplicated neck pain of at least moderate level of pain
  • Lives or works within Greater Seattle WA geographic area

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Karen J Sherman, MPH, PhD

    Group Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2011

Study Completion

March 1, 2014

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations