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

This study has been completed.
Sponsor:
Information provided by:
Cleveland Chiropractic College
ClinicalTrials.gov Identifier:
NCT00497861
First received: July 5, 2007
Last updated: July 6, 2007
Last verified: April 2007
  Purpose

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 Intervention
Back Pain
Procedure: Activator Methods Chiropractic Technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cleveland Chiropractic College:

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

Enrollment: 40
Study Start Date: December 2004
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497861

Locations
United States, Missouri
Cleveland Chiropractic College
Kansas City, Missouri, United States, 64131
Sponsors and Collaborators
Cleveland Chiropractic College
Investigators
Principal Investigator: Mark T Pfefer, D.C., R.N. Cleveland Chiropractic College
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00497861     History of Changes
Other Study ID Numbers: MPMFMA1
Study First Received: July 5, 2007
Last Updated: July 6, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014