Dose of Spinal Manipulation for Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Dose-Response/Efficacy of Manipulation for Chronic LBP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376350
• Other study ID #: U01AT001908
• Secondary ID: U01AT001908
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2006
• Last updated: August 21, 2015
• Start date: March 2007
• Est. completion date: July 2011

Study information

• Verified date: August 2015
• Source: University of Western States
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Spinal Manipulation
5 minutes high velocity, low amplitude lumbar thrust
• Light Massage
light pressure massage of the low back.
• Pulsed Ultrasound
5 minutes pulsed ultrasound

Locations

Country	Name	City	State
United States	Western States Chiropractic College	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Western States	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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 — View Citation

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/s12891-015-0 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Von Korff Pain Scale for low back pain		baseline 1&2, 6, 12, 18, 24, 39, 52 weeks	No
Primary	Modified Von Korff Disability Scale		baseline 1&2, 6, 12, 18, 24, 39, 52 weeks	No
Secondary	Pain days		baseline 1&2, 6, 12, 18, 24, 39, 52 weeks	No
Secondary	Disability days		baseline 1&2, 6, 12, 18, 24, 39, 52 weeks	No
Secondary	Low back pain unpleasantness		baseline 2, 6, 12, 18, 24, 39, 52 weeks	No
Secondary	Fear avoidance beliefs		baseline 2, 6, 12, 18, 24, 39, 52 weeks	No
Secondary	General health status/QoL		baseline 2; 12, 24, 39, 52 weeks	No
Secondary	Patient satisfaction		12 wk	No
Secondary	Healthcare utilization		baseline 2; 6, 12, 18, 24, 39, 52 weeks	No
Secondary	Objective measures		Baseline 2, 6 wk	No
Secondary	Bias monitoring		baseline 1&2; 6, 12, 18, 24, 39, 52 weeks	No