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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497861
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : July 9, 2007
Information provided by:
Cleveland Chiropractic College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Back Pain Procedure: Activator Methods Chiropractic Technique Not Applicable

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Mechanical Force, Manually Assisted Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain: a Randomized Pilot Study
Study Start Date : December 2004
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Revised Oswestry [ Time Frame: December 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria consisted of the following:

  1. 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);
  2. Have undergone surgery involving the low back; (
  3. Have received workers’compensation benefits within the preceding year or were potentially involved in litigation relating to back problems;
  4. Pregnancy, because of possible need for exposure to diagnostic x-rays;
  5. Have participated as a subject in research previously at the trial clinic site;
  6. Have received spinal manipulation within the preceding 3 months or on more than three occasions during the preceding year.
  7. 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

  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497861

United States, Missouri
Cleveland Chiropractic College
Kansas City, Missouri, United States, 64131
Sponsors and Collaborators
Cleveland Chiropractic College
Principal Investigator: Mark T Pfefer, D.C., R.N. Cleveland Chiropractic College Identifier: NCT00497861     History of Changes
Other Study ID Numbers: MPMFMA1
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: July 9, 2007
Last Verified: April 2007

Keywords provided by Cleveland Chiropractic College:
Low back pain
Spinal manipulation
Activator Methods Chiropractic Technique

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms