Low Back PainPhase 1/2AECCNCT01180686
Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back
A Phase 1/2 study testing Activator IV single impulse instrument and Multiple thrust Impulse adjusting instrument in people with Low Back Pain, run by Anglo-European College of Chiropractic at 1 site in United Kingdom.
Trial summary
The purposes of this study are to determine if there is a difference between two treatment methods of spine joints that are not moving as they should as determined by tenderness over the spine and activity of the muscles along side the spine with movement. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Activator IV single impulse instrument and Multiple thrust Impulse adjusting instrument
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Mar 2011
- Phase
- Phase 1/2
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-64 years of age
- Fluent in English
- With non-specific low back pain
- No lumbar manipulation within the prior 24 hours
- Not involved in strenuous back exercise on the day preceding the study
- Have not taken pain medication for two days prior to the study
Who cannot join
- Absolute contraindications to manipulation
- Specific causes for the low back pain
- Involved in or pending litigation for low back pain
- Lumbar related leg pain
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Anglo-European College of Chiropractic
Bournemouth, Dorset, BH5 2DF
Hugh Gemmell, DC, EdD, hgemmell@aecc.ac.uk
Hugh Gemmell, DC, EdD
About this study
Official title: Comparative Effectiveness of the Multiple Thrust Impulse Instrument and the Activator IV Single Thrust Instrument in Correcting a Lumbar Spinal Manipulable Lesion and Improving Lumbar Erector Spinae Flexion-relaxation
The purposes of this study are to determine if there is a difference between two treatment methods of spine joints that are not moving as they should as determined by tenderness over the spine and activity of the muscles along side the spine with movement.
The hypothesis is that there will be no difference between the two types of treatment.
Read the detailed description
Two specialised instruments used for treating manipulable lesions of the spine will be compared using muscle relaxation response of the erector spinae muscles and correction of the spinal manipulable lesion.
- Conditions
- Low Back Pain
- Being tested
- Activator IV single impulse instrument, Multiple thrust Impulse adjusting instrument
- Keywords
- low back pain, chiropractic, manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activator IV single impulse instrumentDevice
Also called Activator IV instrument
This is a manually operated device that delivers a single thrust into the joint involved.
Multiple thrust Impulse adjusting instrumentDevice
Also called Impulse adjusting instrument
A device used for delivering 12 thrusts to the involved joint of the lumbar spine.
| Study group | Role | What they receive |
|---|---|---|
| Multiple thrust Impulse instrument | Active comparator | This instrument automatically delivers 12 thrusts at the same intensity over the joint involved. Receives: Device: Multiple thrust Impulse adjusting instrument |
| Single impulse Activator IV instrument | Active comparator | This is a manual spring loaded device that delivers one thrust to the joint involved Receives: Device: Activator IV single impulse instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of the spinal manipulable lesion
Tests used to determine the presence of a spinal manipulable lesion (a lesion in the spine requiring manipulation) will be used post-treatment to determine of correction has been achieved.
Measured: An average of 5 minutes from the the end of first treatment
Secondary outcomes (2)
Pressure pain threshold over the spinous process
An instrument used to measure pressure in kilograms is placed over the spinous process of the vertebra involved and the level of pressure is recorded when the sensation of pressure changes to pain.
Measured: An average of 5 minutes from the end of the first treatment
Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response
Surface electromyography will be used pre-treatment and post-treatment to determine if a change in muscle activity occurs with flexing the lumbar spine.
Measured: An average of 5 minutes from the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglo-European College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Hugh Gemmell, DC, EdD, Principal investigator, Anglo-European College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180686
- Sponsor's protocol ID
- AECC 30610
- Other IDs
- AECC30610
- Acronym
- AECC
- Status last verified
- Jun 2010
- First submitted
- 30 Jul 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of the Multiple Thrust Impulse Instrument and the Activator IV Single Thrust Instrument in Correcting a Lumbar Spinal Manipulable Lesion and Improving Lumbar Erector Spinae Flexion-relaxation
- ClinicalTrials.gov ID
- NCT01180686
- Acronym / sponsor ID
- AECC / AECC 30610
- Conditions
- Low Back Pain
- Keywords
- low back pain, chiropractic, manipulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anglo-European College of ChiropracticUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 12 Aug 2010 (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.
The purposes of this study are to determine if there is a difference between two treatment methods of spine joints that are not moving as they should as determined by tenderness over the spine and activity of the muscles along side the spine with movement.
The hypothesis is that there will be no difference between the two types of treatment.
Detailed description
Two specialised instruments used for treating manipulable lesions of the spine will be compared using muscle relaxation response of the erector spinae muscles and correction of the spinal manipulable lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple thrust Impulse instrument | Active comparator | Device: Multiple thrust Impulse adjusting instrumentThis instrument automatically delivers 12 thrusts at the same intensity over the joint involved. |
| Single impulse Activator IV instrument | Active comparator | Device: Activator IV single impulse instrumentThis is a manual spring loaded device that delivers one thrust to the joint involved |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18-64 years of age
- Fluent in English
- With non-specific low back pain
- No lumbar manipulation within the prior 24 hours
- Not involved in strenuous back exercise on the day preceding the study
Key exclusion criteria (4 listed)
- Absolute contraindications to manipulation
- Specific causes for the low back pain
- Involved in or pending litigation for low back pain
- Lumbar related leg pain
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 IV single impulse instrumentAlso: Activator IV instrumentThis is a manually operated device that delivers a single thrust into the joint involved. | Device | Single impulse Activator IV instrument |
| Multiple thrust Impulse adjusting instrumentAlso: Impulse adjusting instrumentA device used for delivering 12 thrusts to the involved joint of the lumbar spine. | Device | Multiple thrust Impulse instrument |
Primary outcome
Correction of the spinal manipulable lesion
Time frame: An average of 5 minutes from the the end of first treatment
Tests used to determine the presence of a spinal manipulable lesion (a lesion in the spine requiring manipulation) will be used post-treatment to determine of correction has been achieved.
2 secondary outcomes
Pressure pain threshold over the spinous process
Time frame: An average of 5 minutes from the end of the first treatment
Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response
Time frame: An average of 5 minutes from the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
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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.
Hugh Gemmell, DC, EdD principal investigator
Anglo-European College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Activator IV single impulse instrument and Multiple thrust Impulse adjusting instrument in people with Low Back Pain, run by Anglo-European College of Chiropractic at 1 site in United Kingdom.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Aug 2010. 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 Kingdom. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugh Gemmell, DC, EdD (44202436200 ext. 268, hgemmell@aecc.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of the spinal manipulable lesion (time frame: An average of 5 minutes from the the end of first treatment). 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 12 Aug 2010.