NCT00376350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2 low-back-pain

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

4.3 years

First QC Date

September 12, 2006

Last Update Submit

August 21, 2015

Conditions

Low Back Pain

Keywords

Low Back PainChronicManipulationChiropracticMassage

Outcome Measures

Primary Outcomes (2)

  • Modified Von Korff Pain Scale for low back pain

    baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

  • Modified Von Korff Disability Scale

    baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

Secondary Outcomes (9)

  • Pain days

    baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

  • Disability days

    baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

  • Low back pain unpleasantness

    baseline 2, 6, 12, 18, 24, 39, 52 weeks

  • Fear avoidance beliefs

    baseline 2, 6, 12, 18, 24, 39, 52 weeks

  • General health status/QoL

    baseline 2; 12, 24, 39, 52 weeks

  • +4 more secondary outcomes

Study Arms (4)

High dose manipulation

EXPERIMENTAL

High dose spinal manipulation + ultrasound

Procedure: Spinal ManipulationProcedure: Pulsed Ultrasound

Moderate dose manipulation

EXPERIMENTAL

Moderate dose manipulation + low dose massage + ultrasound

Procedure: Spinal ManipulationProcedure: Light MassageProcedure: Pulsed Ultrasound

Low dose manipulation

EXPERIMENTAL

low dose spinal manipulation + moderate dose massage + ultrasound

Procedure: Spinal ManipulationProcedure: Light MassageProcedure: Pulsed Ultrasound

High dose masssage

OTHER

high dose massage + ultrasound

Procedure: Light MassageProcedure: Pulsed Ultrasound

Interventions

Spinal ManipulationPROCEDURE

5 minutes high velocity, low amplitude lumbar thrust

High dose manipulationLow dose manipulationModerate dose manipulation
Light MassagePROCEDURE

light pressure massage of the low back.

High dose masssageLow dose manipulationModerate dose manipulation
Pulsed UltrasoundPROCEDURE

5 minutes pulsed ultrasound

High dose manipulationHigh dose masssageLow dose manipulationModerate dose manipulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current episode of low back pain
  • mechanical origin
  • Threshold low back pain level

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western States Chiropractic College

Portland, Oregon, 97230, United States

Location

Related Publications (5)

  • 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.

    PMID: 15363431BACKGROUND

  • 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.

    PMID: 24139233RESULT

  • 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.

    PMID: 24410959RESULT

  • 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.

    PMID: 26286532RESULT

  • 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.

    PMID: 24928639RESULT

MeSH Terms

Conditions

Low Back PainBronchiolitis Obliterans Syndrome

Interventions

Manipulation, SpinalUltrasonic Waves

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitationSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Mitchell Haas, DC, MA

    University of Western States

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Vice President of Research

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 14, 2006

Study Start

March 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

US(1)