Effect of Massage on Chronic Low Back Pain

October 11, 2017 updated by: Kaiser Permanente
This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Americans are increasingly seeking care from massage therapists for relief of chronic back pain. However, while initial studies suggest that massage is beneficial for back pain, we have no information about which of the many types of massage is most helpful. We will be conducting a study that compares two distinct therapeutic massage protocols with each other and with usual care for treating chronic back pain. This study is designed to determine which of these massage protocols will be most effective in reducing pain and increasing functionality in people with low back pain. 399 Group Health members with non-specific low back pain lasting at least 3 months will be randomized to one of the two massage groups or to a control group that receives no treatment beyond their usual care. Massage therapists will provide each participant with 10 treatments over 10 weeks. The primary outcomes, function and bothersomeness of low back pain, will be assessed before treatment begins and 10, 26 and 52 weeks after randomization by interviewers who do not know which treatment the participant received. The results of this study will clarify the value of two different types of massage for treating one of the most common, challenging, and expensive health problems plaguing developed countries. The findings will help physicians make informed and confident referrals, consumers and insurers make safe and cost-effective choices, and massage schools make responsible curriculum decisions.

Study Type

Interventional

Enrollment (Anticipated)

399

Phase

  • Phase 2
  • Phase 3

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 Center for Health Studies

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:

  • 20 through 64 years of age
  • members of Group Health Cooperative health plan
  • low back pain lasting at least 3 months

Exclusion Criteria:

  • non-mechanical causes of back pain (e.g., sciatica, systemic/visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer, recent vertebral fracture)
  • inappropriate candidate for massage (active open skin lesions, conditions exacerbated by increased circulation, recent strokes or heart attacks, compromised immune system, systemic edema, hypersensitivity to touch or loss of sensation, recent surgery, active contagious infection)
  • characteristics complicating the interpretation of findings (e.g., involved with litigation or compensation claim, severe or progressive neurological deficit, back surgery within last 3 years, receiving other back treatment)
  • unable to speak or read English
  • had massage for any reason in prior 12 months

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: 2
structural massage
Procedure: massage
UP to 10 massages over 10 weeks
Experimental: 1
relaxation massage
Procedure: massage
UP to 10 massages over 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dysfunction at 10 weeks
Time Frame: 10 weeks
10 weeks
Symptom bothersomeness at 10 weeks
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Dysfunction at 26 and 52 weeks
Time Frame: 26 and 52 weeks
26 and 52 weeks
Symptom bothersomeness at 26 and 52 weeks
Time Frame: 26 adn 52 weeks
26 adn 52 weeks
Anxiety at 10, 26 and 52 weeks
Time Frame: 10 16 and 52 weeks
10 16 and 52 weeks
Depression at 10, 26 and 52 weeks
Time Frame: 10 26 and 52 weeks
10 26 and 52 weeks
Perceived stress at 10, 26 and 52 weeks
Time Frame: 10 26 and 52 weeks
10 26 and 52 weeks
Fear avoidance at 10, 26 and 52 weeks
Time Frame: 10 26 and 52 weeks
10 26 and 52 weeks
Satisfaction with back care at 10 and 26 weeks
Time Frame: 10 and 26 weeks
10 and 26 weeks
General health status (SF-36) at 10, 26 and 52 weeks
Time Frame: 10, 26 and 52 weeks
10, 26 and 52 weeks
Disability days at 10, 26 and 52 weeks
Time Frame: 10 26 52 weeks
10 26 52 weeks
Medication use at 10, 26 and 52 weeks
Time Frame: 10 26 52 weeks
10 26 52 weeks
Adverse experiences at 10 weeks
Time Frame: 10 weeks
10 weeks
Perceptions of massage treatments at 10, 26 and 52 weeks
Time Frame: 10 26 52 weeks
10 26 52 weeks
Use and cost of health care services for back pain at 10, 26 and 52 weeks
Time Frame: 10 26 52 weeks
10 26 52 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: Dan C Cherkin, PhD, Kaiser Permanente

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

August 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 4, 2006

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

  • R01AT001927 (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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