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Effect of Massage on Chronic Low Back Pain

NCT ID: NCT00371384

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

PHASE2/PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-09-30

Brief Summary

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This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.

Detailed Description

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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.

Conditions

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Chronic Low Back Pain (Non-specific, Uncomplicated)

Keywords

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massage back pain effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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2

structural massage

Group Type EXPERIMENTAL

massage

Intervention Type PROCEDURE

UP to 10 massages over 10 weeks

1

relaxation massage

Group Type EXPERIMENTAL

massage

Intervention Type PROCEDURE

UP to 10 massages over 10 weeks

Interventions

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massage

UP to 10 massages over 10 weeks

Intervention Type PROCEDURE

Eligibility Criteria

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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
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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Dan C Cherkin, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Group Health Center for Health Studies

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, Erro J, Delaney K, Deyo RA. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2011 Jul 5;155(1):1-9. doi: 10.7326/0003-4819-155-1-201107050-00002.

Reference Type DERIVED
PMID: 21727288 (View on PubMed)

Cherkin DC, Sherman KJ, Kahn J, Erro JH, Deyo RA, Haneuse SJ, Cook AJ. Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial. Trials. 2009 Oct 20;10:96. doi: 10.1186/1745-6215-10-96.

Reference Type DERIVED
PMID: 19843340 (View on PubMed)

Other Identifiers

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R01AT001927

Identifier Type: NIH

Identifier Source: secondary_id

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R01AT001927

Identifier Type: NIH

Identifier Source: org_study_id

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