Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain

July 6, 2007 updated by: Cleveland Chiropractic College

Comparison of Mechanical Force, Manually Assisted Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain: a Randomized Pilot Study

This study compared the treatment effect of Activator Methods Chiropractic Technique (AMCT) and manual Diversified type spinal manipulative therapy in a sample of patients with acute and sub-acute low back pain.

Study Overview

Status

Completed

Conditions

Back Pain

Intervention / Treatment

Procedure: Activator Methods Chiropractic Technique

Detailed Description

The purpose of this study is to compare the effects of (MFMA) Activator instrument adjusting to manual side posture (HVL) adjustments in patients with acute low back pain.

Primary outcomes measured include pain measurement with a VAS scale, the use of the Oswestry pain scale questionnaire, and the Bournemouth back pain scale questionnaire.

An additional aim of this study is to evaluate feasibility of recruitment, data collection, and other procedures which can lead to additional studies with larger number of subjects including a control group.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

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
- Missouri
  - Kansas City, Missouri, United States, 64131
    - Cleveland 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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Being 18 years or older;
Having current acute or sub-acute low back pain defined as pain that has not lasted more than 16 weeks;
Minimum score of 30mm on a 100mm visual analog pain scale.

Exclusion Criteria:

Exclusion criteria consisted of the following:

Have any of six possible un underlying causes of low back symptoms in their history (spinal osteomyletisosteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome, or cancer, excluding nonmalignant skin cancer);
Have undergone surgery involving the low back; (
Have received workers'compensation benefits within the preceding year or were potentially involved in litigation relating to back problems;
Pregnancy, because of possible need for exposure to diagnostic x-rays;
Have participated as a subject in research previously at the trial clinic site;
Have received spinal manipulation within the preceding 3 months or on more than three occasions during the preceding year.
Subjects with sciatica were excluded if they had any one of the following:
- Ankle dorsiflexion / plantar flexion weakness;
- Great toe extensor weakness;
- Absence of knee or ankle reflexes;
- Loss of light touch sensation in the medial, dorsal, and lateral aspects of the foot;
- Ipsilateral straight-leg-raising test (positive result: leg pain at <60°);
- Crossed straight-leg-raising test (positive result: reproduction of contralateral pain).
These six neurologic tests allow detection of most clinically significant nerve root compromises resulting from L4-L5 or L5-S1 disc herniations, which together make up more than 90% of all clinically significant radiculopathies attributable to lumbar disc herniations (21-25). Because approximately 12% of ambulatory patients with back pain h
Have symptoms of sciatica or leg pain without neurologic compromise related to lumbar disc herniation,[5] investigators attempted to include such subjects in the trial.

The criteria described above were intended to minimize the likelihood of including subjects with a lumbar disc herniation.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Revised Oswestry Time Frame: December 2008	December 2008

Collaborators and Investigators

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

Sponsor

Cleveland Chiropractic College

Investigators

Principal Investigator: Mark T Pfefer, D.C., R.N., Cleveland Chiropractic College

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

December 1, 2004

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

July 5, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (ESTIMATE)

July 9, 2007

Study Record Updates

Last Update Posted (ESTIMATE)