Effect of Massage on Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00371384
First received: August 31, 2006
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Massage on Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Dysfunction at 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Symptom bothersomeness at 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dysfunction at 26 and 52 weeks [ Time Frame: 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Symptom bothersomeness at 26 and 52 weeks [ Time Frame: 26 adn 52 weeks ] [ Designated as safety issue: No ]
  • Anxiety at 10, 26 and 52 weeks [ Time Frame: 10 16 and 52 weeks ] [ Designated as safety issue: No ]
  • Depression at 10, 26 and 52 weeks [ Time Frame: 10 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Perceived stress at 10, 26 and 52 weeks [ Time Frame: 10 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Fear avoidance at 10, 26 and 52 weeks [ Time Frame: 10 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Satisfaction with back care at 10 and 26 weeks [ Time Frame: 10 and 26 weeks ] [ Designated as safety issue: No ]
  • General health status (SF-36) at 10, 26 and 52 weeks [ Time Frame: 10, 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Disability days at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ] [ Designated as safety issue: No ]
  • Medication use at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ] [ Designated as safety issue: No ]
  • Adverse experiences at 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Perceptions of massage treatments at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ] [ Designated as safety issue: Yes ]
  • Use and cost of health care services for back pain at 10, 26 and 52 weeks [ Time Frame: 10 26 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 399
Study Start Date: August 2006
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371384

Locations
United States, Washington
Group Health Center for Health Studies
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Dan C Cherkin, PhD Group Health Cooperative
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00371384     History of Changes
Other Study ID Numbers: R01 AT001927, R01AT001927
Study First Received: August 31, 2006
Last Updated: November 7, 2011
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:
massage
back pain
effectiveness

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014