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Effect of Massage on Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00371384
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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Brief Summary:
This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain (Non-specific, Uncomplicated) Procedure: massage Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Massage on Chronic Low Back Pain
Study Start Date : August 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Dysfunction at 10 weeks [ Time Frame: 10 weeks ]
  2. Symptom bothersomeness at 10 weeks [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Dysfunction at 26 and 52 weeks [ Time Frame: 26 and 52 weeks ]
  2. Symptom bothersomeness at 26 and 52 weeks [ Time Frame: 26 adn 52 weeks ]
  3. Anxiety at 10, 26 and 52 weeks [ Time Frame: 10 16 and 52 weeks ]
  4. Depression at 10, 26 and 52 weeks [ Time Frame: 10 26 and 52 weeks ]
  5. Perceived stress at 10, 26 and 52 weeks [ Time Frame: 10 26 and 52 weeks ]
  6. Fear avoidance at 10, 26 and 52 weeks [ Time Frame: 10 26 and 52 weeks ]
  7. Satisfaction with back care at 10 and 26 weeks [ Time Frame: 10 and 26 weeks ]
  8. General health status (SF-36) at 10, 26 and 52 weeks [ Time Frame: 10, 26 and 52 weeks ]
  9. Disability days at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ]
  10. Medication use at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ]
  11. Adverse experiences at 10 weeks [ Time Frame: 10 weeks ]
  12. Perceptions of massage treatments at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ]
  13. Use and cost of health care services for back pain at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371384


Locations
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United States, Washington
Group Health Center for Health Studies
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Dan C Cherkin, PhD Kaiser Permanente
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00371384    
Other Study ID Numbers: R01AT001927 ( U.S. NIH Grant/Contract )
R01AT001927 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by Kaiser Permanente:
massage
back pain
effectiveness
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations