Back PainNCT00497861
Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain
A study testing Activator Methods Chiropractic Technique in people with Back Pain, run by Cleveland Chiropractic College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Activator Methods Chiropractic Technique
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Chiropractic College
Kansas City, Missouri, 64131
About this study
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
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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Activator Methods Chiropractic Technique
- Keywords
- Low back pain, Chiropractic, Spinal manipulation, Activator Methods Chiropractic Technique
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activator Methods Chiropractic TechniqueProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Oswestry
Measured: December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startDec 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Chiropractic College
- Sponsor type
- University, hospital or other
- Investigators
- Mark T Pfefer, D.C., R.N., Principal investigator, Cleveland Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497861
- Sponsor's protocol ID
- MPMFMA1
- Status last verified
- Apr 2007
- First submitted
- 5 Jul 2007
- Last updated
- 9 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00497861
- Acronym / sponsor ID
- MPMFMA1
- Conditions
- Back Pain
- Keywords
- Low back pain, Chiropractic, Spinal manipulation, Activator Methods Chiropractic Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cleveland Chiropractic CollegeUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activator Methods Chiropractic Technique | Procedure or surgery | – |
Primary outcome
Revised Oswestry
Time frame: December 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark T Pfefer, D.C., R.N. principal investigator
Cleveland Chiropractic College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activator Methods Chiropractic Technique in people with Back Pain, run by Cleveland Chiropractic College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Oswestry (time frame: December 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2007.