Back Pain Lower Back ChronicNCT01865539
Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
A study testing Custom Foot Orthotic in people with Back Pain Lower Back Chronic, run by Canandaigua VA Medical Center at 1 site in United States.
Trial summary
A randomized sham controlled trial evaluating the efficacy of the use of custom foot orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes that those veterans with chronic lower back pain who receive the custom foot orthotics will show greater improvements in pain and disability… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Custom Foot Orthotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65 Lower back pain ≥ 3 months in duration Pain elicited upon deep palpation of the lumbar erector spinae musculature Primary complaint of CLBP from L1 to Sacroiliac joint inclusive. Ability/willingness to use orthotics in their shoes Numeric Pain Rating Scale (NRPS) of ≥ 3
- 30 mm on the Visual Analogue Scale (VAS)
- 20% for the Modified Oswestry Disability Index (mODI)
Who cannot join
- spinal surgery, spinal injections or injections in their feet within the past 6 months Inability to use orthotics in shoes Custom foot orthotics within the past 12 months Currently undergoing Chiropractic, Physical Therapy or Acupuncture treatment for their chronic lower back pain.
- evidence of cauda equina syndrome, spinal neoplasia or metastatic disease, destructive joint pathology such as rheumatoid arthritis bowel/bladder dysfunction (associated with the back pain) peripheral neuropathy or progressive lumbosacral radiculopathy, progressive myelopathy or neurogenic claudication.
- open workers compensation or no fault case.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
Rochester, New York, 14620
About this study
A randomized sham controlled trial evaluating the efficacy of the use of custom foot orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes that those veterans with chronic lower back pain who receive the custom foot orthotics will show greater improvements in pain and disability associated with the chronic lower back pain than those who receive the sham orthotic.
Read the detailed description
Specific Aim 1: Utilizing a gold standard sham controlled randomized trial design, we will evaluate the change in pain, back related disability and quality of life in Veterans with chronic lower back pain who utilize either a custom foot orthotic or a sham orthotic.
As part of this aim the investigators will build on the teams strength of recruiting and enrolling Veteran's with chronic lower back pain into a randomized trial. The investigators will collect baseline pain and disability measures utilizing validated tools. Once the patients are enrolled, utilizing the "gold standard" placebo controlled design the investigators will randomize patients to receive either a custom foot orthotic or a sham orthotic. The Veterans will then be assessed at 5, 12 and 24-weeks post baseline to evaluate differences in pain and disability. Based on previous studies on the effectiveness of custom foot orthotics the investigators hypothesize that that Veteran's who receive the custom orthotic will experience less pain and disability as compared to those who receive the sham orthotics.
Specific Aim 2: To evaluate baseline characteristics of Veterans with chronic lower back pain predictive of responsiveness to custom foot orthotics including age, BMI, psychosocial characteristics and arch classification.
Focusing on the Veterans who receive the custom foot orthotic, the investigators next examine the important characteristics that may predict those Veterans who are most likely to benefit from wearing custom foot orthotics. Assessing potential confounders or facilitators of effectiveness of the custom foot orthotic will allow the investigators to best describe potential mechanisms of responsiveness. The investigators have chosen previously described confounders to responsiveness to treatment of chronic lower back pain, specifically age, body mass index and psychosocial characteristics. This methodology is particularly important in a sham controlled trial to assess if effectiveness or lack of thereof, is a factor of the intervention or from other confounding variables. The investigators have also chosen to evaluate the arch classification based on the measurement of the Veterans arch; again this allows for specific recommendations concerning use of this product. Based on previous studies on the effectiveness of custom foot orthotics in addition to previous studies evaluating chronic lower back pain the investigators hypothesize that those Veterans who are older, have a higher BMI and greater fear avoidance belief scores will show less responsiveness to the custom foot orthotics as compared to those younger Veterans who have a lower BMI and lower fear avoidance belief scores. In addition based on previous biomechanical literature, the investigators feel that those Veterans with a lower arch will show the greatest responsiveness to the custom foot orthotic.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Custom Foot Orthotic, Sham Orthotic
- Keywords
- Chronic lower back pain, Custom foot orthotics, Veterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Foot OrthoticDevice
Also called Foot Levelers Custom Foot Orthotic
Custom foot orthotic with custom design pads
Sham OrthoticDevice
Leather insert without the custom design pads
| Study group | Role | What they receive |
|---|---|---|
| Custom Foot Orthotic | Active comparator | Custom foot orthotic Receives: Device: Custom Foot Orthotic |
| Sham Orthotic | Sham comparator | Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads. Receives: Device: Sham Orthotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scales (VAS): VAS is rated from 0 to 100mm with 0 being no pain at all and 100mm being the worst pain imaginable. The test has shown test-retest reliability, intra-examiner reliability and inter-examiner reliability.
Measured: 24 weeks.
Secondary outcomes (2)
Modified Oswestry Disability Index (mODI)
The back pain specific, self-rating scale evaluates the degree of functional impairment that a patient is experiencing in a number of activities of daily living. Oswestry is scored on a scale of 0-50 with 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
Measured: 24 weeks.
Patient Reported Outcome Measurement Information System (PROMIS) Physical Function
For PROMIS measures, higher scores equals more of the concept being measured (more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. Specifically for PROMIS Physical function 50 indicates the reference population, therefore a score of 40 would be lower physical function.
Measured: 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2016
- Study completionJun 2016
Why it stopped: Difficulty with recruitment/funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back Pain Lower Back ChronicStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Foot Levelers, Inc., Northeast College of Health Sciences
- Responsible party
- Principal investigator, Paul Dougherty, DC, Canandaigua VA Medical Center
- Investigators
- Paul E Dougherty, DC, Principal investigator, Canandaigua VA Medical Center/ New York Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865539
- Sponsor's protocol ID
- MIRB00558
- Status last verified
- Apr 2022
- First submitted
- 20 May 2013
- Last updated
- 16 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sahar T, Cohen MJ, Uval-Ne'eman V, Kandel L, Odebiyi DO, Lev I, Brezis M, Lahad A. Insoles for prevention and treatment of back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine (Phila Pa 1976). 2009 Apr 20;34(9):924-33. doi: 10.1097/BRS.0b013e31819f29be.
PubMed 19359999
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT01865539
- Acronym / sponsor ID
- MIRB00558
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Chronic lower back pain, Custom foot orthotics, Veterans
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment/funding
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Collaborators
- Foot Levelers, Inc., Northeast College of Health Sciences
- Study start
- May 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Posted 16 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized sham controlled trial evaluating the efficacy of the use of custom foot orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes that those veterans with chronic lower back pain who receive the custom foot orthotics will show greater improvements in pain and disability associated with the chronic lower back pain than those who receive the sham orthotic.
Detailed description
Specific Aim 1: Utilizing a gold standard sham controlled randomized trial design, we will evaluate the change in pain, back related disability and quality of life in Veterans with chronic lower back pain who utilize either a custom foot orthotic or a sham orthotic.
As part of this aim the investigators will build on the teams strength of recruiting and enrolling Veteran's with chronic lower back pain into a randomized trial. The investigators will collect baseline pain and disability measures utilizing validated tools. Once the patients are enrolled, utilizing the "gold standard" placebo controlled design the investigators will randomize patients to receive either a custom foot orthotic or a sham orthotic. The Veterans will then be assessed at 5, 12 and 24-weeks post baseline to evaluate differences in pain and disability. Based on previous studies on the effectiveness of custom foot orthotics the investigators hypothesize that that Veteran's who receive the custom orthotic will experience less pain and disability as compared to those who receive the sham orthotics.
Specific Aim 2: To evaluate baseline characteristics of Veterans with chronic lower back pain predictive of responsiveness to custom foot orthotics including age, BMI, psychosocial characteristics and arch classification.
Focusing on the Veterans who receive the custom foot orthotic, the investigators next examine the important characteristics that may predict those Veterans who are most likely to benefit from wearing custom foot orthotics. Assessing potential confounders or facilitators of effectiveness of the custom foot orthotic will allow the investigators to best describe potential mechanisms of responsiveness. The investigators have chosen previously described confounders to responsiveness to treatment of chronic lower back pain, specifically age, body mass index and psychosocial characteristics. This methodology is particularly important in a sham controlled trial to assess if effectiveness or lack of thereof, is a factor of the intervention or from other confounding variables. The investigators have also chosen to evaluate the arch classification based on the measurement of the Veterans arch; again this allows for specific recommendations concerning use of this product. Based on previous studies on the effectiveness of custom foot orthotics in addition to previous studies evaluating chronic lower back pain the investigators hypothesize that those Veterans who are older, have a higher BMI and greater fear avoidance belief scores will show less responsiveness to the custom foot orthotics as compared to those younger Veterans who have a lower BMI and lower fear avoidance belief scores. In addition based on previous biomechanical literature, the investigators feel that those Veterans with a lower arch will show the greatest responsiveness to the custom foot orthotic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom Foot Orthotic | Active comparator | Device: Custom Foot OrthoticCustom foot orthotic |
| Sham Orthotic | Sham comparator | Device: Sham OrthoticWill be a sham orthotic that will be the same as the actual orthotic without the custom support pads. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-65 Lower back pain ≥ 3 months in duration Pain elicited upon deep palpation of the lumbar erector spinae musculature Primary complaint of CLBP from L1 to Sacroiliac joint inclusive. Ability/willingness to use orthotics in their shoes Numeric Pain Rating Scale (NRPS) of ≥ 3
- 30 mm on the Visual Analogue Scale (VAS)
- 20% for the Modified Oswestry Disability Index (mODI)
Key exclusion criteria (3 listed)
- spinal surgery, spinal injections or injections in their feet within the past 6 months Inability to use orthotics in shoes Custom foot orthotics within the past 12 months Currently undergoing Chiropractic, Physical Therapy or Acupuncture treatment for their chronic lower back pain.
- evidence of cauda equina syndrome, spinal neoplasia or metastatic disease, destructive joint pathology such as rheumatoid arthritis bowel/bladder dysfunction (associated with the back pain) peripheral neuropathy or progressive lumbosacral radiculopathy, progressive myelopathy or neurogenic claudication.
- open workers compensation or no fault case.
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 |
|---|---|---|
| Custom Foot OrthoticAlso: Foot Levelers Custom Foot OrthoticCustom foot orthotic with custom design pads | Device | Custom Foot Orthotic |
| Sham OrthoticLeather insert without the custom design pads | Device | Sham Orthotic |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 24 weeks.
Visual Analog Scales (VAS): VAS is rated from 0 to 100mm with 0 being no pain at all and 100mm being the worst pain imaginable. The test has shown test-retest reliability, intra-examiner reliability and inter-examiner reliability.
2 secondary outcomes
Modified Oswestry Disability Index (mODI)
Time frame: 24 weeks.
Patient Reported Outcome Measurement Information System (PROMIS) Physical Function
Time frame: 24 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19359999Sahar T, Cohen MJ, Uval-Ne'eman V, Kandel L, Odebiyi DO, Lev I, Brezis M, Lahad A. Insoles for prevention and treatment of back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine (Phila Pa 1976). 2009 Apr 20;34(9):924-33. doi: 10.1097/BRS.0b013e31819f29be.
- New York Chiropractic CollegeLink provided by the sponsor.
- Foot Levelers WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Paul E Dougherty, DC principal investigator
Canandaigua VA Medical Center/ New York 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 Custom Foot Orthotic in people with Back Pain Lower Back Chronic, run by Canandaigua VA Medical Center 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 3 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: stopped early, as of the sponsor's last update on 16 May 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (VAS) (time frame: 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865539, which also lists 1 linked publication.
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 16 May 2022.