NCT00497861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
Last Updated

July 9, 2007

Status Verified

April 1, 2007

First QC Date

July 5, 2007

Last Update Submit

July 6, 2007

Conditions

Keywords

Low back painChiropracticSpinal manipulationActivator Methods Chiropractic Technique

Outcome Measures

Primary Outcomes (1)

  • Revised Oswestry

    December 2008

Interventions

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Chiropractic College

Kansas City, Missouri, 64131, United States

Location

MeSH Terms

Conditions

Back PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark T Pfefer, D.C., R.N.

    Cleveland Chiropractic College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 9, 2007

Study Start

December 1, 2004

Study Completion

April 1, 2007

Last Updated

July 9, 2007

Record last verified: 2007-04

Locations