Dose of Spinal Manipulation for Chronic Low Back Pain

August 21, 2015 updated by: Mitchell Haas, University of Western States

Dose-Response/Efficacy of Manipulation for Chronic LBP

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97230
        • Western States Chiropractic College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Pulsed Ultrasound
5 minutes pulsed ultrasound
Procedure: Light Massage
light pressure massage of the low back.
EXPERIMENTAL: Low dose manipulation
low dose spinal manipulation + moderate dose massage + ultrasound
Procedure: Spinal Manipulation
5 minutes high velocity, low amplitude lumbar thrust
Procedure: Pulsed Ultrasound
5 minutes pulsed ultrasound
Procedure: Light Massage
light pressure massage of the low back.
OTHER: High dose masssage
high dose massage + ultrasound
Procedure: Pulsed Ultrasound
5 minutes pulsed ultrasound
Procedure: Light Massage
light pressure massage of the low back.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain days
Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Disability days
Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Low back pain unpleasantness
Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks
baseline 2, 6, 12, 18, 24, 39, 52 weeks
Fear avoidance beliefs
Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks
baseline 2, 6, 12, 18, 24, 39, 52 weeks
General health status/QoL
Time Frame: baseline 2; 12, 24, 39, 52 weeks
baseline 2; 12, 24, 39, 52 weeks
Patient satisfaction
Time Frame: 12 wk
12 wk
Healthcare utilization
Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks
baseline 2; 6, 12, 18, 24, 39, 52 weeks
Objective measures
Time Frame: Baseline 2, 6 wk
Baseline 2, 6 wk
Bias monitoring
Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks
baseline 1&2; 6, 12, 18, 24, 39, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western States

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

September 12, 2006

First Submitted That Met QC Criteria

September 12, 2006

First Posted (ESTIMATE)

September 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01AT001908 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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