Lumbar RadiculopathyNCT03532230
Cost Effectiveness of OMT for Chronic Low Back Pain
An observational study of Lumbar Radiculopathy and Lesion of Sciatic Nerve, Left Lower Limb, run by Rowan University at 3 sites in United States.
Trial summary
The specific aim of this study is to conduct a prospective, multicenter cohort study over four months to compare the cost of standard of allopathic care (control group, N=90) versus standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a cohort of 180 consecutive patients seeking… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Lumbar Radiculopathy, Lesion of Sciatic Nerve, Left Lower Limb, Lesion of Sciatic Nerve, Right Lower Limb
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Mar 2019to 28 Feb 2020
- Phase
- Observational
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective, multicenter, observational study will follow two groups of patients over four months. The first (experimental) group will be 90 new patients seeking treatment for chronic back pain at three osteopathic clinics. The experimental group will receive standard of care plus osteopathic manipulative treatment (OMT) for low back pain. The second (control) group will be 90 new patients who will receive only standard care without OMT for chronic low back pain as delivered at a local pain clinic.
Who may be able to join
- Patients diagnosed with chronic low back pain (lasting more than 3 months) who are between 18 to 84 years old will be eligible for the study. Inclusion criteria will be specified by the following the 2017/2018 International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes associated with chronic low back pain:
- M54.16 Lumbar radiculopathy
- G57.01 Lesion of sciatic nerve, right lower limb
- G57.02 Lesion of sciatic nerve, left lower limb
- M48.061 Lumbar spinal stenosis, without neurogenic claudication
- M48.062 Lumbar spinal stenosis, with neurogenic claudication
Show all 10Show fewer
- M47.816 Lumbar spondylosis
- M48.07 Lumbar spinal stenosis, lumbosacral
- M54.41 Lumbago with sciatica, right side
- M54.42 Lumbago with sciatica, left side
Who cannot join
- Patients with diabetic neuropathy, congenital lumbar and sacral abnormalities, lumbar fracture, multiple myeloma, metastatic bone disease, history of spinal and/or pain lasting less than three months will be excluded from the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Michigan State University
East Lansing, Michigan, 48824
Rowan University SOM NeuroMusculoskeletal Institute
Stratford, New Jersey, 08084
The Pain Associates
Voorhees Township, New Jersey, 08043
About this study
Official title: Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain
The specific aim of this study is to conduct a prospective, multicenter cohort study over four months to compare the cost of standard of allopathic care (control group, N=90) versus standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a cohort of 180 consecutive patients seeking treatment for chronic low back pain at three osteopathic clinics and three allopathic medical clinics (offering only standard care) located in three different regions of the United States.
- Conditions
- Lumbar Radiculopathy, Lesion of Sciatic Nerve, Left Lower Limb, Lesion of Sciatic Nerve, Right Lower Limb, Lumbar Spinal Stenosis, Lumbar Spondylosis, Lumbago With Sciatica, Left Side
- Being tested
- Osteopathic Manipulative Treatment (OMT)
- Keywords
- Chronic Low Back Pain, Osteopathic Manipulative Medicine
- Medical subject headings
- Radiculopathy, Sciatic Neuropathy, Spinal Stenosis, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Procedure or surgery
No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | 90 new patients seeking treatment for chronic low back pain. This group will receive standard care plus osteopathic manipulative treatment (OMT) for low back pain. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) | |
| Control Group | 90 new patients seeking treatment for chronic low back pain. This group will receive only standard care without osteopathic manipulative treatment (OMT) for low back pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Costs
The cost data will be collected from the electronic medical record of each patient enrolled in the study. Because the costs for comparable treatments vary with respect to different socioeconomic and geographic regions in the United States, the mean total-healthcare costs per patient will be calculated based on codes for 2018 Medicare fee schedules for each clinic listed in the Current Procedural Terminology (CPT) for office visits, medications, OMT, and referrals.
Measured: 4 months
Secondary outcomes (1)
Total Morphine-Equivalents
Various pain medications that might have been prescribed will be calculated and compared to morphine equivalents at admission to the study and after four months at each of the treatment centers.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start22 Mar 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Principal investigator, Richard Jermyn, DO, Rowan University
- Investigators
- Richard Jermyn, DO, Principal investigator, Rowan University School of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532230
- Sponsor's protocol ID
- AOA-OMT
- Status last verified
- May 2020
- First submitted
- 9 May 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03532230
- Acronym / sponsor ID
- AOA-OMT
- Conditions
- Lumbar Radiculopathy, Lesion of Sciatic Nerve, Left Lower Limb, Lesion of Sciatic Nerve, Right Lower Limb, Lumbar Spinal Stenosis, Lumbar Spondylosis, Lumbago With Sciatica, Left Side
- Keywords
- Chronic Low Back Pain, Osteopathic Manipulative Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 22 May 2018 (actual)
- 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 specific aim of this study is to conduct a prospective, multicenter cohort study over four months to compare the cost of standard of allopathic care (control group, N=90) versus standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a cohort of 180 consecutive patients seeking treatment for chronic low back pain at three osteopathic clinics and three allopathic medical clinics (offering only standard care) located in three different regions of the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Procedure: Osteopathic Manipulative Treatment (OMT)90 new patients seeking treatment for chronic low back pain. This group will receive standard care plus osteopathic manipulative treatment (OMT) for low back pain. |
| Control Group | – | –90 new patients seeking treatment for chronic low back pain. This group will receive only standard care without osteopathic manipulative treatment (OMT) for low back pain. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, multicenter, observational study will follow two groups of patients over four months. The first (experimental) group will be 90 new patients seeking treatment for chronic back pain at three osteopathic clinics. The experimental group will receive standard of care plus osteopathic manipulative treatment (OMT) for low back pain. The second (control) group will be 90 new patients who will receive only standard care without OMT for chronic low back pain as delivered at a local pain clinic.
Key inclusion criteria (10 listed)
- Patients diagnosed with chronic low back pain (lasting more than 3 months) who are between 18 to 84 years old will be eligible for the study. Inclusion criteria will be specified by the following the 2017/2018 International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes associated with chronic low back pain:
- M54.16 Lumbar radiculopathy
- G57.01 Lesion of sciatic nerve, right lower limb
- G57.02 Lesion of sciatic nerve, left lower limb
- M48.061 Lumbar spinal stenosis, without neurogenic claudication
Key exclusion criteria (1 listed)
- Patients with diabetic neuropathy, congenital lumbar and sacral abnormalities, lumbar fracture, multiple myeloma, metastatic bone disease, history of spinal and/or pain lasting less than three months will be excluded from the study.
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 |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected. | Procedure or surgery | Experimental Group |
Primary outcome
Total Costs
Time frame: 4 months
The cost data will be collected from the electronic medical record of each patient enrolled in the study. Because the costs for comparable treatments vary with respect to different socioeconomic and geographic regions in the United States, the mean total-healthcare costs per patient will be calculated based on codes for 2018 Medicare fee schedules for each clinic listed in the Current Procedural Terminology (CPT) for office visits, medications, OMT, and referrals.
1 secondary outcome
Total Morphine-Equivalents
Time frame: 4 months
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 4 May 2020.
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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.
Richard Jermyn, DO principal investigator
Rowan University School of Osteopathic Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Radiculopathy and Lesion of Sciatic Nerve, Left Lower Limb, run by Rowan University at 3 sites 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 10 inclusion and 1 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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Total Costs (time frame: 4 months). 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 4 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.