Back to resultsComparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activator Methods Chiropractic Technique
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring Low back pain, Chiropractic, Spinal manipulation, Activator Methods Chiropractic Technique
Eligibility Criteria
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.
Sites / Locations
- Cleveland Chiropractic College
Outcomes
Primary Outcome Measures
Revised Oswestry
Secondary Outcome Measures
Full Information
NCT ID
NCT00497861
First Posted
July 5, 2007
Last Updated
July 6, 2007
Sponsor
Cleveland Chiropractic College
1. Study Identification
Unique Protocol Identification Number
NCT00497861
Brief Title
Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain
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 Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cleveland Chiropractic College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Low back pain, Chiropractic, Spinal manipulation, Activator Methods Chiropractic Technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Activator Methods Chiropractic Technique
Primary Outcome Measure Information:
Title
Revised Oswestry
Time Frame
December 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark T Pfefer, D.C., R.N.
Organizational Affiliation
Cleveland Chiropractic College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Chiropractic College
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
12. IPD Sharing Statement
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Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain
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