Low Back PainPhase 1/2NCT01704807
Duration of Spinal Manipulation Effects as Influenced by Orthotics
A Phase 1/2 study testing foot orthotics in people with Low Back Pain, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- foot orthotics
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current low back pain episode present for one month or more
- No change in the past month in prescription medications affecting musculoskeletal pain
- Able to speak and understand English adequately to complete study forms
- Score on Roland-Morris questionnaire of 7.5 or higher or
- Average score on Chiropractic pain Index (Now, Average, and Worst scales from the Quadruple VAS pain scale) of 4 or higher.
Who cannot join
- Use of foot orthotics within the past 12 months
- Previous lumbar spine surgery
- Ongoing treatment for lower back pain by other health care providers other than stable prescription medications affecting musculoskeletal pain.
- Clinically significant chronic inflammatory spinal arthritis
- Severe osteoporosis for which spinal manipulation is contraindicated
- Spinal pathology or fracture
Show all 13Show fewer
- Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
- History of bleeding disorder
- Known arterial aneurysm
- Pending/current litigation pertaining to back pain, including workers compensation claims
- Current pregnancy
- Lack of means of contacting which might preclude successful completion of study requirements
- Does not speak , read or understand English to an extent which would affect the subject's capacity to participate in informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Logan College of Chiropractic/University Programs
Chesterfield, Missouri, 63017
About this study
Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques.
Read the detailed description
Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.
- Conditions
- Low Back Pain
- Being tested
- foot orthotics, Sham foot orthotic
- Keywords
- Low Back Pain, Chronic, Orthotic Device, Applied Kinesiology, Manual Muscle Testing, Chiropractic
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot orthoticsDevice
Also called Foot Levelers, Full length ultra step foot orthotics
Experimental wore experimental orthotics throughout the study period as much of the day as possible.
Sham foot orthoticDevice
Also called Foot Levelers flat insoles similar to Full Length Ultra Step
Control group wore sham insoles as much of the time as possible for the duration of the study period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention, Custom Orthotics | Active comparator | Wearing custom foot orthotics Receives: Device: foot orthotics |
| Sham Foot Orthotic | Sham comparator | Wearing sham or flat shoe insoles Receives: Device: Sham foot orthotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadruple Visual Analog Pain Scale
Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
Measured: Six weeks
Roland-Morris Questionnaire
Questionnaire listing activities of daily living, impacted by low back pain.
Measured: Six weeks
Secondary outcomes (2)
Number of fixated vertebral levels
Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge.
Measured: Six weeks
Number of tested muscles grade 4 and below
Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharine Conable, DC, Principal investigator, Logan College of Chiropractic/University ProgramsAnthony Rosner, PhD, Principal investigator, International College of Applied Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704807
- Sponsor's protocol ID
- LCC-12-RD0519110317
- Status last verified
- Oct 2012
- First submitted
- 24 Sep 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Spinal Manipulation Effects as Influenced by Orthotics
- ClinicalTrials.gov ID
- NCT01704807
- Acronym / sponsor ID
- LCC-12-RD0519110317
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Chronic, Orthotic Device, Applied Kinesiology, Manual Muscle Testing, Chiropractic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Oct 2012 (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.
Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques.
Detailed description
Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention, Custom Orthotics | Active comparator | Device: foot orthoticsWearing custom foot orthotics |
| Sham Foot Orthotic | Sham comparator | Device: Sham foot orthoticWearing sham or flat shoe insoles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current low back pain episode present for one month or more
- No change in the past month in prescription medications affecting musculoskeletal pain
- Able to speak and understand English adequately to complete study forms
- Score on Roland-Morris questionnaire of 7.5 or higher or
- Average score on Chiropractic pain Index (Now, Average, and Worst scales from the Quadruple VAS pain scale) of 4 or higher.
Key exclusion criteria (13 listed)
- Use of foot orthotics within the past 12 months
- Previous lumbar spine surgery
- Ongoing treatment for lower back pain by other health care providers other than stable prescription medications affecting musculoskeletal pain.
- Clinically significant chronic inflammatory spinal arthritis
- Severe osteoporosis for which spinal manipulation is contraindicated
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 |
|---|---|---|
| foot orthoticsAlso: Foot Levelers, Full length ultra step foot orthoticsExperimental wore experimental orthotics throughout the study period as much of the day as possible. | Device | Intervention, Custom Orthotics |
| Sham foot orthoticAlso: Foot Levelers flat insoles similar to Full Length Ultra StepControl group wore sham insoles as much of the time as possible for the duration of the study period. | Device | Sham Foot Orthotic |
Primary outcome
Quadruple Visual Analog Pain Scale
Time frame: Six weeks
Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
Roland-Morris Questionnaire
Time frame: Six weeks
Questionnaire listing activities of daily living, impacted by low back pain.
2 secondary outcomes
Number of fixated vertebral levels
Time frame: Six weeks
Number of tested muscles grade 4 and below
Time frame: Six weeks
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 11 Oct 2012.
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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.
Katharine Conable, DC principal investigator
Logan College of Chiropractic/University Programs
Anthony Rosner, PhD principal investigator
International College of Applied Kinesiology
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 foot orthotics in people with Low Back Pain, 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 5 inclusion and 13 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 11 Oct 2012. 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?
Quadruple Visual Analog Pain Scale (time frame: Six weeks). The study lists 2 primary outcomes in all. 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 11 Oct 2012.