Chronic Low Back PainNCT02089750
Orthotic Use for Chronic Low Back Pain
A study testing Orthotics, Orthotics Plus Chiropractic Care and Wait List in people with Chronic Low Back Pain, run by National University of Health Sciences at 1 site in United States.
Trial summary
The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain. The hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Orthotics, Orthotics Plus Chiropractic Care and Wait List
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Subjects must be symptomatic with current pain between T12 and the SI joints with or without radiating pain at an average score of 4 or higher on the NPRS scale
- Symptoms must have been present for at least three months
Who cannot join
- Use of custom-made orthotics in the past 6 months
- Ongoing active conservative care (such as physical therapy or chiropractic care) for the low back, leg, or foot received in the past 6 months (excluding the use of oral medications or daily at-home exercises for general well-being).
- Current or future litigation for any healthcare concern
- Not fluent or literate in the English language. We will not be able to provide multiple translators within this study
- Brain disorders (e.g., dementia, Alzheimers Disease , etc.) that would lead to difficulty in questionnaire completion
- Chronic pain other than low back pain, such as fibromyalgia or multiple sclerosis
Show all 17Show fewer
- Clinically significant chronic inflammatory spinal arthritis
- Spinal pathology or fracture
- 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
- Previous lumbar spine surgery
- Severe skeletal deformity of the foot
- Peripheral neuropathy due to disorders such as diabetes
- Low back pain that is not reproducible
- Current pregnancy
- Other conditions that may affect the subjects' ability to participate throughout the duration of the study or exclude patients from participation in the study, including contraindications to orthotic use or chiropractic spinal manipulations
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Health Sciences
Lombard, Illinois, 60148
About this study
Official title: Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial
The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain.
The hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will further improve patients' low back pain and dysfunction while maintaining that improvement during the one year study follow-up period.
Read more
Specific Aims:
- To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and dysfunction (Oswestry Disability Index) in patients with chronic low back pain after six weeks of custom-made shoe orthotic use with or without chiropractic care as compared to no care.
- To determine the changes in perceived pain levels and dysfunction in patients with chronic low back pain after twelve weeks of custom-made shoe orthotic use.
- To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months following the 12 week treatment period.
- Conditions
- Chronic Low Back Pain
- Being tested
- Orthotics, Orthotics Plus Chiropractic Care, Wait List
- Keywords
- Low Back Pain, Chiropractic, Shoe Orthotics
- 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.
OrthoticsOther
Orthotics Plus Chiropractic CareOther
The six week Chiropractic Care portion of this intervention may include the use of ice packs, hot packs, massage, and chiropractic manipulations to the spine or lower extremities (utilizing High Velocity Low Amplitude and/or Flexion Distraction manipulations).
Wait ListOther
| Study group | Role | What they receive |
|---|---|---|
| Orthotics | Active comparator | Subjects are asked to wear custom-made shoe orthotics for a 12 week study period. Receives: Other: Orthotics |
| Orthotics Plus Chiropractic Care | Active comparator | Subjects are asked to wear custom-made shoe orthotics for a 12 week study period in addition to receiving Chiropractic Care 1-4 times per week during the first 6 weeks of the 12 week study period. Receives: Other: Orthotics; Other: Orthotics Plus Chiropractic Care |
| Wait List | Other | The group serves as a cross-over control group. Subjects are asked to avoid any new therapies for the first 6 weeks of the 12 week study and during the last six weeks they are fitted for the custom-made shoe orthotics. Receives: Other: Orthotics; Other: Wait List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a numeric scale from 0-10, wherein patients can select (by circling or otherwise selecting) the one number along that line that best describes the pain being inquired about during the specified time period. The NPRS is one of the most frequently used methods for the measurement of clinical pain.
Measured: This primary outcome measure will be collected at the Randomization Visit and Week 6.
Modified Oswestry Disability Index (MODI)
The Modified Oswestry Disability Index, a condition specific questionnaire covering 10 areas of daily living and expressing the degree of disability as a percentage. The measured areas include: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment. Each category is scored on a continuum from 0 to 5 points, for a possible total score of 50 out of 50, popularly described as "100% disability."
Measured: This primary outcome measure will be collected at the Randomization Visit and Week 6.
Secondary outcomes (2)
Numeric Pain Rating Scale (NPRS)
Measured: This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care.
Modified Oswestry Disability Index (MODI)
Measured: This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Foot Levelers, Inc.
- Responsible party
- Principal investigator, Jerrilyn Cambron, DC, PhD, National University of Health Sciences
- Investigators
- Jerrilyn Cambron, DC, MPH, PhD, Principal investigator, National University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089750
- Sponsor's protocol ID
- NUHS IRB_H-1203
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2014
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cambron JA, Dexheimer JM, Duarte M, Freels S. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Sep;98(9):1752-1762. doi: 10.1016/j.apmr.2017.03.028. Epub 2017 Apr 30.
PubMed 28465224
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02089750
- Acronym / sponsor ID
- NUHS IRB_H-1203
- Conditions
- Chronic Low Back Pain
- Keywords
- Low Back Pain, Chiropractic, Shoe Orthotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- National University of Health SciencesUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Foot Levelers, Inc.
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Mar 2014 (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 goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain.
The hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will further improve patients' low back pain and dysfunction while maintaining that improvement during the one year study follow-up period.
Specific Aims:
- To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and dysfunction (Oswestry Disability Index) in patients with chronic low back pain after six weeks of custom-made shoe orthotic use with or without chiropractic care as compared to no care.
- To determine the changes in perceived pain levels and dysfunction in patients with chronic low back pain after twelve weeks of custom-made shoe orthotic use.
- To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months following the 12 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orthotics | Active comparator | Other: OrthoticsSubjects are asked to wear custom-made shoe orthotics for a 12 week study period. |
| Orthotics Plus Chiropractic Care | Active comparator | Other: Orthotics, Other: Orthotics Plus Chiropractic CareSubjects are asked to wear custom-made shoe orthotics for a 12 week study period in addition to receiving Chiropractic Care 1-4 times per week during the first 6 weeks of the 12 week study period. |
| Wait List | Other | Other: Orthotics, Other: Wait ListThe group serves as a cross-over control group. Subjects are asked to avoid any new therapies for the first 6 weeks of the 12 week study and during the last six weeks they are fitted for the custom-made shoe orthotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Subjects must be symptomatic with current pain between T12 and the SI joints with or without radiating pain at an average score of 4 or higher on the NPRS scale
- Symptoms must have been present for at least three months
Key exclusion criteria (17 listed)
- Use of custom-made orthotics in the past 6 months
- Ongoing active conservative care (such as physical therapy or chiropractic care) for the low back, leg, or foot received in the past 6 months (excluding the use of oral medications or daily at-home exercises for general well-being).
- Current or future litigation for any healthcare concern
- Not fluent or literate in the English language. We will not be able to provide multiple translators within this study
- Brain disorders (e.g., dementia, Alzheimers Disease , etc.) that would lead to difficulty in questionnaire completion
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 |
|---|---|---|
| Orthotics | Other | Orthotics, Orthotics Plus Chiropractic Care, Wait List |
| Orthotics Plus Chiropractic CareThe six week Chiropractic Care portion of this intervention may include the use of ice packs, hot packs, massage, and chiropractic manipulations to the spine or lower extremities (utilizing High Velocity Low Amplitude and/or Flexion Distraction manipulations). | Other | Orthotics Plus Chiropractic Care |
| Wait List | Other | Wait List |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: This primary outcome measure will be collected at the Randomization Visit and Week 6.
The Numeric Pain Rating Scale (NPRS) is a numeric scale from 0-10, wherein patients can select (by circling or otherwise selecting) the one number along that line that best describes the pain being inquired about during the specified time period. The NPRS is one of the most frequently used methods for the measurement of clinical pain.
Modified Oswestry Disability Index (MODI)
Time frame: This primary outcome measure will be collected at the Randomization Visit and Week 6.
The Modified Oswestry Disability Index, a condition specific questionnaire covering 10 areas of daily living and expressing the degree of disability as a percentage. The measured areas include: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment. Each category is scored on a continuum from 0 to 5 points, for a possible total score of 50 out of 50, popularly described as "100% disability."
2 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care.
Modified Oswestry Disability Index (MODI)
Time frame: This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care.
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 31 Mar 2017.
- Derived from this study: PubMed 28465224Cambron JA, Dexheimer JM, Duarte M, Freels S. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Sep;98(9):1752-1762. doi: 10.1016/j.apmr.2017.03.028. Epub 2017 Apr 30.
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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.
Jerrilyn Cambron, DC, MPH, PhD principal investigator
National University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthotics, Orthotics Plus Chiropractic Care and Wait List in people with Chronic Low Back Pain, run by National University of Health Sciences 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 17 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 31 Mar 2017. 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?
Numeric Pain Rating Scale (NPRS) (time frame: This primary outcome measure will be collected at the Randomization Visit and Week 6.). 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?
On the ClinicalTrials.gov record for NCT02089750, 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 31 Mar 2017.