Dose of Spinal Manipulation for Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Spinal Manipulation
Light Massage
Pulsed Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Chronic, Manipulation, Chiropractic, Massage
Eligibility Criteria
Inclusion Criteria:
- Current episode of low back pain
- mechanical origin
- Threshold low back pain level
Exclusion Criteria:
- Contraindications to spinal manipulation or massage
- Complicating conditions that could confound clinical outcome
- Prophylactic use of prescription medication
- Health-related litigation, claims, or disability compensation
Sites / Locations
- Western States Chiropractic College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
High dose manipulation
Moderate dose manipulation
Low dose manipulation
High dose masssage
Arm Description
High dose spinal manipulation + ultrasound
Moderate dose manipulation + low dose massage + ultrasound
low dose spinal manipulation + moderate dose massage + ultrasound
high dose massage + ultrasound
Outcomes
Primary Outcome Measures
Modified Von Korff Pain Scale for low back pain
Modified Von Korff Disability Scale
Secondary Outcome Measures
Pain days
Disability days
Low back pain unpleasantness
Fear avoidance beliefs
General health status/QoL
Patient satisfaction
Healthcare utilization
Objective measures
Bias monitoring
Full Information
NCT ID
NCT00376350
First Posted
September 12, 2006
Last Updated
August 21, 2015
Sponsor
University of Western States
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00376350
Brief Title
Dose of Spinal Manipulation for Chronic Low Back Pain
Official Title
Dose-Response/Efficacy of Manipulation for Chronic LBP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western States
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Chronic, Manipulation, Chiropractic, Massage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose manipulation
Arm Type
Experimental
Arm Description
High dose spinal manipulation + ultrasound
Arm Title
Moderate dose manipulation
Arm Type
Experimental
Arm Description
Moderate dose manipulation + low dose massage + ultrasound
Arm Title
Low dose manipulation
Arm Type
Experimental
Arm Description
low dose spinal manipulation + moderate dose massage + ultrasound
Arm Title
High dose masssage
Arm Type
Other
Arm Description
high dose massage + ultrasound
Intervention Type
Procedure
Intervention Name(s)
Spinal Manipulation
Intervention Description
5 minutes high velocity, low amplitude lumbar thrust
Intervention Type
Procedure
Intervention Name(s)
Light Massage
Intervention Description
light pressure massage of the low back.
Intervention Type
Procedure
Intervention Name(s)
Pulsed Ultrasound
Intervention Description
5 minutes pulsed ultrasound
Primary Outcome Measure Information:
Title
Modified Von Korff Pain Scale for low back pain
Time Frame
baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Title
Modified Von Korff Disability Scale
Time Frame
baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Secondary Outcome Measure Information:
Title
Pain days
Time Frame
baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Title
Disability days
Time Frame
baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Title
Low back pain unpleasantness
Time Frame
baseline 2, 6, 12, 18, 24, 39, 52 weeks
Title
Fear avoidance beliefs
Time Frame
baseline 2, 6, 12, 18, 24, 39, 52 weeks
Title
General health status/QoL
Time Frame
baseline 2; 12, 24, 39, 52 weeks
Title
Patient satisfaction
Time Frame
12 wk
Title
Healthcare utilization
Time Frame
baseline 2; 6, 12, 18, 24, 39, 52 weeks
Title
Objective measures
Time Frame
Baseline 2, 6 wk
Title
Bias monitoring
Time Frame
baseline 1&2; 6, 12, 18, 24, 39, 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current episode of low back pain
mechanical origin
Threshold low back pain level
Exclusion Criteria:
Contraindications to spinal manipulation or massage
Complicating conditions that could confound clinical outcome
Prophylactic use of prescription medication
Health-related litigation, claims, or disability compensation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Haas, DC, MA
Organizational Affiliation
University of Western States
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western States Chiropractic College
City
Portland
State/Province
Oregon
ZIP/Postal Code
97230
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15363431
Citation
Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. doi: 10.1016/j.spinee.2004.02.008.
Results Reference
background
PubMed Identifier
24139233
Citation
Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.
Results Reference
result
PubMed Identifier
24410959
Citation
Haas M, Vavrek D, Neradilek MB, Polissar N. A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain. BMC Complement Altern Med. 2014 Jan 13;14:16. doi: 10.1186/1472-6882-14-16.
Results Reference
result
PubMed Identifier
26286532
Citation
Vavrek D, Haas M, Neradilek MB, Polissar N. Prediction of pain outcomes in a randomized controlled trial of dose-response of spinal manipulation for the care of chronic low back pain. BMC Musculoskelet Disord. 2015 Aug 19;16:205. doi: 10.1186/s12891-015-0632-0.
Results Reference
result
PubMed Identifier
24928639
Citation
Vavrek DA, Sharma R, Haas M. Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial. J Manipulative Physiol Ther. 2014 Jun;37(5):300-11. doi: 10.1016/j.jmpt.2014.03.002.
Results Reference
result
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Dose of Spinal Manipulation for Chronic Low Back Pain
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