Effect of Massage on Chronic Low Back Pain

Chronic Low Back Pain (Non-specific, Uncomplicated) Clinical Trial

Official title:

Effect of Massage on Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371384
• Other study ID #: R01AT001927
• Secondary ID: R01AT001927
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 31, 2006
• Last updated: October 11, 2017
• Start date: August 2006
• Est. completion date: September 2009

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: September 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain (Non-specific, Uncomplicated)
• Low Back Pain

Intervention

Procedure:
• massage
UP to 10 massages over 10 weeks

Locations

Country	Name	City	State
United States	Group Health Center for Health Studies	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysfunction at 10 weeks		10 weeks
Primary	Symptom bothersomeness at 10 weeks		10 weeks
Secondary	Dysfunction at 26 and 52 weeks		26 and 52 weeks
Secondary	Symptom bothersomeness at 26 and 52 weeks		26 adn 52 weeks
Secondary	Anxiety at 10, 26 and 52 weeks		10 16 and 52 weeks
Secondary	Depression at 10, 26 and 52 weeks		10 26 and 52 weeks
Secondary	Perceived stress at 10, 26 and 52 weeks		10 26 and 52 weeks
Secondary	Fear avoidance at 10, 26 and 52 weeks		10 26 and 52 weeks
Secondary	Satisfaction with back care at 10 and 26 weeks		10 and 26 weeks
Secondary	General health status (SF-36) at 10, 26 and 52 weeks		10, 26 and 52 weeks
Secondary	Disability days at 10, 26 and 52 weeks		10 26 52 weeks
Secondary	Medication use at 10, 26 and 52 weeks		10 26 52 weeks
Secondary	Adverse experiences at 10 weeks		10 weeks
Secondary	Perceptions of massage treatments at 10, 26 and 52 weeks		10 26 52 weeks
Secondary	Use and cost of health care services for back pain at 10, 26 and 52 weeks		10 26 52 weeks