Chronic Low Back PainNCT00976664

Orthotic Use for Chronic Low Back Pain

A study testing Shoe orthotic and Shoe Orthotic Wait Group in people with Chronic Low Back Pain, run by National University of Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for a three month period. 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?: Shoe orthotic and Shoe Orthotic Wait Group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Feb 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females must be at least 18 years old.
Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
Symptoms must have been present for at least three months.

Who cannot join

Use of custom-made shoe orthotics in the past year
Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
Current or future litigation for low back pain.
Chronic pain other then low back pain such as fibromyalgia

Show all 10Show fewer

Low back surgery in last six months.
Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
Peripheral neuropathy due to disorders such as diabetes.
Low back or leg pain that is not reproducible.

Trial locations and contacts

1 site in 1 country.

United States1 site

National University of Health Sciences
Lombard, Illinois, 60148

Other trials in United States

About this study

Conditions: Chronic Low Back Pain
Being tested: Shoe orthotic, Shoe Orthotic Wait Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shoe orthoticDevice
Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
Shoe Orthotic Wait GroupDevice
This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.

Study groups in NCT00976664
Study group	Role	What they receive
Orthotic group	Active comparator	Subjects are asked to wear custom-made shoe orthotics for a 12 week study period. Receives: Device: Shoe orthotic
Shoe Orthotic Wait group	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 6 weeks they are fitted for the custom-made shoe orthotics. Receives: Device: Shoe Orthotic Wait Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analog Scale (VAS)
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
Measured: Randomization, Week 6, and Week 12
Oswestry Disability Index (ODI)
This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.
Measured: Randomization, Week 6, and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Feb 2010

First posted14 Sep 2009 (estimated)
Study startJun 2009
Primary completionFeb 2010
Study completionFeb 2010

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.
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: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00976664
Sponsor's protocol ID: NUHS IRB H-0904
Status last verified: Mar 2017
First submitted: 11 Sep 2009
Last updated: 3 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Orthotic Use for Chronic Low Back Pain
ClinicalTrials.gov ID: NCT00976664
Acronym / sponsor ID: NUHS IRB H-0904
Conditions: Chronic Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: National University of Health SciencesUniversity, hospital or other
Collaborators: Foot Levelers, Inc.
Study start: Jun 2009
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 14 Sep 2009 (estimated)
Results: Posted 17 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Orthotic group	Active comparator	Device: Shoe orthoticSubjects are asked to wear custom-made shoe orthotics for a 12 week study period.
Shoe Orthotic Wait group	Other	Device: Shoe Orthotic Wait GroupThe 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 6 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)

Males and females must be at least 18 years old.
Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
Symptoms must have been present for at least three months.

Key exclusion criteria (10 listed)

Use of custom-made shoe orthotics in the past year
Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
Current or future litigation for low back 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
Shoe orthoticShoe orthotics are devices worn in the shoe to modify the patient's stance and gait.	Device	Orthotic group
Shoe Orthotic Wait GroupThis group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.	Device	Shoe Orthotic Wait group

Primary outcome

Visual Analog Scale (VAS)
Time frame: Randomization, Week 6, and Week 12
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
Oswestry Disability Index (ODI)
Time frame: Randomization, Week 6, and Week 12
This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.

Results and safety

Results posted to the registry on 17 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Orthotic Group	25	22
Wait Group	25	24

Primary outcome: Visual Analog Scale (VAS)

Time frame: Randomization, Week 6, and Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Orthotic Group n = 22	Wait Group n = 24
Randomization	5.0 (2.2)	4.3 (1.9)
Week 6	2.8 (2.6)	4.1 (2.3)
Week 12	2.7 (2.5)	2.9 (2.3)

Orthotic Group vs Wait Group: p = .0007, Wilcoxon (Mann-Whitney)
Orthotic Group vs Wait Group: p = .3913, Wilcoxon (Mann-Whitney)

Population analysed: Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.

Primary outcome: Oswestry Disability Index (ODI)

Time frame: Randomization, Week 6, and Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Orthotic Group n = 22	Wait Group n = 24
Randomization	10.0 (4.9)	10.4 (5.8)
Week 6	6.2 (5.2)	10.2 (5.4)
Week 12	6.1 (5.3)	8.9 (5.5)

Orthotic Group vs Wait Group: p = .002, Wilcoxon (Mann-Whitney)
Orthotic Group vs Wait Group: p = .0336, Wilcoxon (Mann-Whitney)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Orthotic Group	0 of 25 (0%)	0 of 25 (0%)	Not reported
Wait Group	0 of 25 (0%)	0 of 25 (0%)	Not reported

Limitations and caveats (from the sponsor): Subjects and clinicians were not blind to group. Subjects came from 1 region of the US, majority were white and \~50 years old. One type of orthotic was used as the only form of care. Several subjects felt discomfort/stiffness rather than pain.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Low Back Pain

Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
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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 Shoe orthotic and Shoe Orthotic Wait Group 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 10 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 3 May 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?

Yes. Results are posted in the registry (first posted 17 Nov 2014). 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: Randomization, Week 6, and Week 12). 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 NCT00976664.

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 3 May 2017.