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Effect of Massage on Chronic Low Back Pain

Kaiser Permanente logo

Kaiser Permanente

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated)

Treatments

Procedure: massage

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00371384
R01AT001927 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

399 estimated patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

399 participants in 2 patient groups

2
Experimental group
Description:
structural massage
Treatment:
Procedure: massage
1
Experimental group
Description:
relaxation massage
Treatment:
Procedure: massage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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