Dose of Spinal Manipulation for Chronic Low Back Pain - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00376350

Purpose

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.

Condition	Intervention	Phase
Low Back Pain	Procedure: Spinal Manipulation Procedure: Light Massage Procedure: Pulsed Ultrasound	Phase II Phase III

MedlinePlus related topics: Back Pain Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Dose-Response/Efficacy of Manipulation for Chronic LBP

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Modified Von Korff Pain Scale for low back pain [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Modified Von Korff Disability Scale [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Disability days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Low back pain unpleasantness [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Fear avoidance beliefs [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
General health status/QoL [ Time Frame: baseline 2; 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Patient satisfaction [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
Healthcare utilization [ Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Objective measures [ Time Frame: Baseline 2, 6 wk ] [ Designated as safety issue: No ]
Bias monitoring [ Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High dose manipulation: Experimental High dose spinal manipulation + ultrasound	Procedure: Spinal Manipulation 5 minutes high velocity, low amplitude lumbar thrust Procedure: Pulsed Ultrasound 5 minutes pulsed ultrasound
Moderate dose manipulation: Experimental Moderate dose manipulation + low dose massage + ultrasound	Procedure: Spinal Manipulation 5 minutes high velocity, low amplitude lumbar thrust Procedure: Light Massage light pressure massage of the low back. Procedure: Pulsed Ultrasound 5 minutes pulsed ultrasound
Low dose manipulation: Experimental low dose spinal manipulation + moderate dose massage + ultrasound	Procedure: Spinal Manipulation 5 minutes high velocity, low amplitude lumbar thrust Procedure: Light Massage light pressure massage of the low back. Procedure: Pulsed Ultrasound 5 minutes pulsed ultrasound
High dose masssage high dose massage = ultrasound	Procedure: Light Massage light pressure massage of the low back. Procedure: Pulsed Ultrasound 5 minutes pulsed ultrasound

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376350

Contacts

Contact: Jonathan Levine

800-678-9072

jlevine@wschiro.edu

Locations

United States, Oregon
Western States Chiropractic College	Recruiting
Portland, Oregon, United States, 97230
Contact: Jonathan Levine 800-678-9072 jlevine@wschiro.edu
Principal Investigator: Mitchell Haas, DC, MA
Sub-Investigator: Adele Spegman, PhD, RN
Sub-Investigator: David Peterson, DC

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Mitchell Haas, DC, MA

Western States Chiropractic College

More Information

Publications:

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.

Responsible Party:	Western States Chiropractic College ( Joseph Brimhall )
Study ID Numbers:	U01 AT001908
Study First Received:	September 12, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00376350
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Low Back Pain
Chronic
Manipulation
Chiropractic
Massage

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009