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

Sponsor:	University of Western States
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):	Mitchell Haas, University of Western States
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dose-Response/Efficacy of Manipulation for Chronic LBP

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Ultrasound

U.S. FDA Resources

Further study details as provided by University of Western States:

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 ]

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

Arms	Assigned Interventions
Experimental: High dose manipulation High dose spinal manipulation + ultrasound	Procedure: Spinal Manipulation 5 minutes high velocity, low amplitude lumbar thrust Procedure: Pulsed Ultrasound 5 minutes pulsed ultrasound
Experimental: Moderate dose manipulation 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
Experimental: Low dose manipulation 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

Locations

United States, Oregon
Western States Chiropractic College
Portland, Oregon, United States, 97230

Sponsors and Collaborators

University of Western States

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Mitchell Haas, DC, MA

University of Western States

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:	Mitchell Haas, Associate Vice President of Research, University of Western States
ClinicalTrials.gov Identifier:	NCT00376350 History of Changes
Other Study ID Numbers:	U01 AT001908, U01AT001908
Study First Received:	September 12, 2006
Last Updated:	February 2, 2012
Health Authority:	United States: Federal Government

Keywords provided by University of Western States:

Low Back Pain
Chronic
Manipulation
Chiropractic
Massage

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012