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Dose of Spinal Manipulation for Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Mitchell Haas, University of Western States
ClinicalTrials.gov Identifier:
NCT00376350
First received: September 12, 2006
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  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 2
Phase 3

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
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:

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 May 23, 2013