Spinal ManipulationPhase 1/2NCT00728572
Logan Basic Technique Measured by Surface Electromyography (EMG)
A Phase 1/2 study testing Logan Basic Technique and Surface EMG and Surface EMG in people with Spinal Manipulation, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
The purpose of this investigation is to determine the effect of Logan Basic Technique apex contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via surface EMG. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Manipulation
- What is being tested?
- Logan Basic Technique and Surface EMG and Surface EMG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students in trimesters 1 - 3.
- Naive to the Logan Basic Technique adjusting protocol.
Who cannot join
- Students in trimesters 4 - 10.
- Pregnant females or females who can possibly be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Logan University, College of Chiropractic
St Louis, Missouri, 63017
About this study
Official title: The Effect of Logan Basic Technique Apex Contact Adjustment on the Motor Recruitment Pattern in the Erector Spinae.
The purpose of this investigation is to determine the effect of Logan Basic Technique apex contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via surface EMG.
Read the detailed description
LBT is a low force adjusting technique that focuses on the foundation segment of the spine, the sacrum, with application of contact on the sacrotuberous ligament which relieves fatigued and strained muscles, particularly intrinsic muscles of the back. Surface electromyography (EMG) is a method of analyzing the activity level of superficial muscles. It is convenient and advantageous when studying muscle relaxation which occurs in biofeedback studies
- Conditions
- Spinal Manipulation
- Being tested
- Logan Basic Technique and Surface EMG, Surface EMG, Logan Basic Technique Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Logan Basic Technique and Surface EMGProcedure or surgery
Participant will receive a brief Basic Technique and Surface EMG examination and Basic Technique treatment.
Surface EMGOther
Surface EMG only, no intervention
Logan Basic Technique ShamProcedure or surgery
Participants will receive a sham Basic Technique treatment, not indicated by examination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participant will receive a brief exam, a Basic Technique apex contact adjustment and Surface EMG. Receives: Procedure: Logan Basic Technique and Surface EMG; Other: Surface EMG |
| Sham | Sham comparator | Participants will receive a sham Basic Technique adjustment (an adjacent contact not indicated by examination)and surface EMG. Receives: Other: Surface EMG; Procedure: Logan Basic Technique Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface EMG
Measured: 15 minute sEMG: 5 mins before, 5 mins during and 5 mins after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal ManipulationStudies 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
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Snyder, DC, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728572
- Sponsor's protocol ID
- SR0331080126
- Status last verified
- Sep 2016
- First submitted
- 1 Aug 2008
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Logan Basic Technique Apex Contact Adjustment on the Motor Recruitment Pattern in the Erector Spinae.
- ClinicalTrials.gov ID
- NCT00728572
- Acronym / sponsor ID
- SR0331080126
- Conditions
- Spinal Manipulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Aug 2008 (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 purpose of this investigation is to determine the effect of Logan Basic Technique apex contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via surface EMG.
Detailed description
LBT is a low force adjusting technique that focuses on the foundation segment of the spine, the sacrum, with application of contact on the sacrotuberous ligament which relieves fatigued and strained muscles, particularly intrinsic muscles of the back. Surface electromyography (EMG) is a method of analyzing the activity level of superficial muscles. It is convenient and advantageous when studying muscle relaxation which occurs in biofeedback studies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Logan Basic Technique and Surface EMG, Other: Surface EMGParticipant will receive a brief exam, a Basic Technique apex contact adjustment and Surface EMG. |
| Sham | Sham comparator | Other: Surface EMG, Procedure: Logan Basic Technique ShamParticipants will receive a sham Basic Technique adjustment (an adjacent contact not indicated by examination)and surface EMG. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Students in trimesters 1 - 3.
- Naive to the Logan Basic Technique adjusting protocol.
Key exclusion criteria (2 listed)
- Students in trimesters 4 - 10.
- Pregnant females or females who can possibly be pregnant.
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 |
|---|---|---|
| Logan Basic Technique and Surface EMGParticipant will receive a brief Basic Technique and Surface EMG examination and Basic Technique treatment. | Procedure or surgery | Experimental |
| Surface EMGSurface EMG only, no intervention | Other | Experimental, Sham |
| Logan Basic Technique ShamParticipants will receive a sham Basic Technique treatment, not indicated by examination. | Procedure or surgery | Sham |
Primary outcome
Surface EMG
Time frame: 15 minute sEMG: 5 mins before, 5 mins during and 5 mins after intervention
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 15 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Logan Basic Technique and Surface EMG and Surface EMG in people with Spinal Manipulation, run by Logan College of Chiropractic 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 2 inclusion and 2 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 15 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
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?
Surface EMG (time frame: 15 minute sEMG: 5 mins before, 5 mins during and 5 mins after intervention). 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 15 Sep 2016.