Dose of Spinal Manipulation for Chronic Low Back Pain

NCT ID: NCT00376350

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High dose manipulation

High dose spinal manipulation + ultrasound

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type PROCEDURE

5 minutes high velocity, low amplitude lumbar thrust

Pulsed Ultrasound

Intervention Type PROCEDURE

5 minutes pulsed ultrasound

Moderate dose manipulation

Moderate dose manipulation + low dose massage + ultrasound

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type PROCEDURE

5 minutes high velocity, low amplitude lumbar thrust

Light Massage

Intervention Type PROCEDURE

light pressure massage of the low back.

Pulsed Ultrasound

Intervention Type PROCEDURE

5 minutes pulsed ultrasound

Low dose manipulation

low dose spinal manipulation + moderate dose massage + ultrasound

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type PROCEDURE

5 minutes high velocity, low amplitude lumbar thrust

Light Massage

Intervention Type PROCEDURE

light pressure massage of the low back.

Pulsed Ultrasound

Intervention Type PROCEDURE

5 minutes pulsed ultrasound

High dose masssage

high dose massage + ultrasound

Group Type OTHER

Light Massage

Intervention Type PROCEDURE

light pressure massage of the low back.

Pulsed Ultrasound

Intervention Type PROCEDURE

5 minutes pulsed ultrasound

Interventions

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Spinal Manipulation

5 minutes high velocity, low amplitude lumbar thrust

Intervention Type PROCEDURE

Light Massage

light pressure massage of the low back.

Intervention Type PROCEDURE

Pulsed Ultrasound

5 minutes pulsed ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Western States

OTHER

Sponsor Role lead

Responsible Party

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Mitchell Haas

Associate Vice President of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitchell Haas, DC, MA

Role: PRINCIPAL_INVESTIGATOR

University of Western States

Locations

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Western States Chiropractic College

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15363431 (View on PubMed)

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.

Reference Type RESULT
PMID: 24139233 (View on PubMed)

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.

Reference Type RESULT
PMID: 24410959 (View on PubMed)

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.

Reference Type RESULT
PMID: 26286532 (View on PubMed)

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.

Reference Type RESULT
PMID: 24928639 (View on PubMed)

Other Identifiers

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U01AT001908

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01AT001908

Identifier Type: NIH

Identifier Source: org_study_id

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