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Dose of Spinal Manipulation for Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376350
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : August 24, 2015
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Mitchell Haas, University of Western States

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Spinal Manipulation Procedure: Light Massage Procedure: Pulsed Ultrasound Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-Response/Efficacy of Manipulation for Chronic LBP
Study Start Date : March 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Modified Von Korff Pain Scale for low back pain [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]
  2. Modified Von Korff Disability Scale [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]

Secondary Outcome Measures :
  1. Pain days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]
  2. Disability days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]
  3. Low back pain unpleasantness [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ]
  4. Fear avoidance beliefs [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ]
  5. General health status/QoL [ Time Frame: baseline 2; 12, 24, 39, 52 weeks ]
  6. Patient satisfaction [ Time Frame: 12 wk ]
  7. Healthcare utilization [ Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks ]
  8. Objective measures [ Time Frame: Baseline 2, 6 wk ]
  9. Bias monitoring [ Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376350


Locations
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United States, Oregon
Western States Chiropractic College
Portland, Oregon, United States, 97230
Sponsors and Collaborators
University of Western States
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Mitchell Haas, DC, MA University of Western States
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Mitchell Haas, Associate Vice President of Research, University of Western States
ClinicalTrials.gov Identifier: NCT00376350    
Other Study ID Numbers: U01AT001908 ( U.S. NIH Grant/Contract )
U01AT001908 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015
Keywords provided by Mitchell Haas, University of Western States:
Low Back Pain
Chronic
Manipulation
Chiropractic
Massage
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations