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Completed

NCT Number: NCT00371384

Effect of Massage on Chronic Low Back Pain

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

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Key information

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated) Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Group Health Center for Health Studies

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage

Procedure

UP to 10 massages over 10 weeks

Primary outcomes

  1. Dysfunction at 10 weeks

    Time frame: 10 weeks

  2. Symptom bothersomeness at 10 weeks

    Time frame: 10 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 4, 2006
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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