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CompletedNCT00376350Updated Aug 24, 2015

Dose of Spinal Manipulation for Chronic Low Back Pain

A Phase 2/3 interventional study of Spinal Manipulation and Light Massage in Low Back Pain, sponsored by University of Western States. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-24.

Sponsored by University of Western States · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain

Keywords

  • Low Back Pain
  • Chronic
  • Manipulation
  • Chiropractic
  • Massage
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 400 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University of Western States is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    High dose manipulation

    High dose spinal manipulation + ultrasound

    Procedure: Spinal Manipulation · Procedure: Pulsed Ultrasound

  • Experimental
    Moderate dose manipulation

    Moderate dose manipulation + low dose massage + ultrasound

    Procedure: Spinal Manipulation · Procedure: Light Massage · Procedure: Pulsed Ultrasound

  • Experimental
    Low dose manipulation

    low dose spinal manipulation + moderate dose massage + ultrasound

    Procedure: Spinal Manipulation · Procedure: Light Massage · Procedure: Pulsed Ultrasound

  • Other
    High dose masssage

    high dose massage + ultrasound

    Procedure: Light Massage · Procedure: Pulsed Ultrasound

Interventions

  • ProcedureSpinal Manipulation

    5 minutes high velocity, low amplitude lumbar thrust

  • ProcedureLight Massage

    light pressure massage of the low back.

  • ProcedurePulsed Ultrasound

    5 minutes pulsed ultrasound

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Western States Chiropractic College
    Portland, Oregon 97230, United States
08

References and documents

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. doi: 10.1016/j.spinee.2004.02.008. PubMed 15363431 ↗
  • 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. PubMed 24139233 ↗
  • 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. PubMed 24410959 ↗
  • 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. PubMed 26286532 ↗
  • 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. PubMed 24928639 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00376350
Lead sponsor
University of Western States
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Mitchell Haas (Associate Vice President of Research, University of Western States) — Principal investigator
First posted
Sep 14, 2006
Start date
Mar 2007
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Aug 24, 2015

Study contacts

Mitchell Haas, DC, MA
principal investigator · University of Western States

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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