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Completed

NCT Number: NCT00497861

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Chiropractic College

Kansas City, Missouri, 64131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activator Methods Chiropractic Technique

Procedure

Primary outcomes

  1. Revised Oswestry

    Time frame: December 2008

Sponsors and collaborators

Lead sponsor

Cleveland Chiropractic College

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Jul 9, 2007
Registry last updated
Jul 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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