Clinical trial NCT00376350: Dose of Spinal Manipulation for Chronic Low Back Pain
Official title: Dose-Response/Efficacy of Manipulation for Chronic LBP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Keywords: Low Back Pain
Chronic
Manipulation
Chiropractic
Massage
Lead sponsor: University of Western States
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-09-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Modified Von Korff Pain Scale for low back pain
timeFrame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
measure: Modified Von Korff Disability Scale
timeFrame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Secondary outcomes:
measure: Pain days
timeFrame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
measure: Disability days
timeFrame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
measure: Low back pain unpleasantness
timeFrame: baseline 2, 6, 12, 18, 24, 39, 52 weeks
measure: Fear avoidance beliefs
timeFrame: baseline 2, 6, 12, 18, 24, 39, 52 weeks
measure: General health status/QoL
timeFrame: baseline 2; 12, 24, 39, 52 weeks
measure: Patient satisfaction
timeFrame: 12 wk
measure: Healthcare utilization
timeFrame: baseline 2; 6, 12, 18, 24, 39, 52 weeks
measure: Objective measures
timeFrame: Baseline 2, 6 wk
measure: Bias monitoring
timeFrame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Western States Chiropractic College
state: Oregon
Study officials:
affiliation: University of Western States
name: Mitchell Haas, DC, MA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.