Effect of Massage on Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain (Non-specific, Uncomplicated)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
massage
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain (Non-specific, Uncomplicated) focused on measuring massage, back pain, effectiveness
Eligibility 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
Sites / Locations
- Group Health Center for Health Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
2
1
Arm Description
structural massage
relaxation massage
Outcomes
Primary Outcome Measures
Dysfunction at 10 weeks
Symptom bothersomeness at 10 weeks
Secondary Outcome Measures
Dysfunction at 26 and 52 weeks
Symptom bothersomeness at 26 and 52 weeks
Anxiety at 10, 26 and 52 weeks
Depression at 10, 26 and 52 weeks
Perceived stress at 10, 26 and 52 weeks
Fear avoidance at 10, 26 and 52 weeks
Satisfaction with back care at 10 and 26 weeks
General health status (SF-36) at 10, 26 and 52 weeks
Disability days at 10, 26 and 52 weeks
Medication use at 10, 26 and 52 weeks
Adverse experiences at 10 weeks
Perceptions of massage treatments at 10, 26 and 52 weeks
Use and cost of health care services for back pain at 10, 26 and 52 weeks
Full Information
NCT ID
NCT00371384
First Posted
August 31, 2006
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00371384
Brief Title
Effect of Massage on Chronic Low Back Pain
Official Title
Effect of Massage on Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain (Non-specific, Uncomplicated)
Keywords
massage, back pain, effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
399 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
structural massage
Arm Title
1
Arm Type
Experimental
Arm Description
relaxation massage
Intervention Type
Procedure
Intervention Name(s)
massage
Intervention Description
UP to 10 massages over 10 weeks
Primary Outcome Measure Information:
Title
Dysfunction at 10 weeks
Time Frame
10 weeks
Title
Symptom bothersomeness at 10 weeks
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Dysfunction at 26 and 52 weeks
Time Frame
26 and 52 weeks
Title
Symptom bothersomeness at 26 and 52 weeks
Time Frame
26 adn 52 weeks
Title
Anxiety at 10, 26 and 52 weeks
Time Frame
10 16 and 52 weeks
Title
Depression at 10, 26 and 52 weeks
Time Frame
10 26 and 52 weeks
Title
Perceived stress at 10, 26 and 52 weeks
Time Frame
10 26 and 52 weeks
Title
Fear avoidance at 10, 26 and 52 weeks
Time Frame
10 26 and 52 weeks
Title
Satisfaction with back care at 10 and 26 weeks
Time Frame
10 and 26 weeks
Title
General health status (SF-36) at 10, 26 and 52 weeks
Time Frame
10, 26 and 52 weeks
Title
Disability days at 10, 26 and 52 weeks
Time Frame
10 26 52 weeks
Title
Medication use at 10, 26 and 52 weeks
Time Frame
10 26 52 weeks
Title
Adverse experiences at 10 weeks
Time Frame
10 weeks
Title
Perceptions of massage treatments at 10, 26 and 52 weeks
Time Frame
10 26 52 weeks
Title
Use and cost of health care services for back pain at 10, 26 and 52 weeks
Time Frame
10 26 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan C Cherkin, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Center for Health Studies
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21727288
Citation
Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, Erro J, Delaney K, Deyo RA. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2011 Jul 5;155(1):1-9. doi: 10.7326/0003-4819-155-1-201107050-00002.
Results Reference
derived
PubMed Identifier
19843340
Citation
Cherkin DC, Sherman KJ, Kahn J, Erro JH, Deyo RA, Haneuse SJ, Cook AJ. Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial. Trials. 2009 Oct 20;10:96. doi: 10.1186/1745-6215-10-96.
Results Reference
derived
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Effect of Massage on Chronic Low Back Pain
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