Low Back PainPhase 4NCT04129437
Acute Low Back Pain in the Emergency Department Treated With Osteopathic Manipulative Treatment Versus NSAIDs
A Phase 4 study testing Ibuprofen and Osteopathic manipulative treatment in people with Low Back Pain, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Acute low back pain is the fifth most common presenting complaint to the emergency department, accounting for approximately 4.4% of annual visits. The treatment for acute low back pain is often NSAIDs or other analgesic medications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Ibuprofen and Osteopathic manipulative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to Jan 2023
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients 18 years of age or older with the chief complaint of acute low back pain defined as symptom duration no longer than four weeks prior to ED presentation and having clinical findings of somatic dysfunction (muscle edema, erythema, bogginess, hypertonic muscles, asymmetry of tissue, pain with movement, severe/sharp tenderness).
Who cannot join
- Patients will be excluded if they previously participated in the study, history of gastrointestinal bleed, allergies to NSAIDs, NSAID use 4 hours prior to arrival, history of or concern for spinal column fracture, current diagnosis of active malignancy or metastatic cancer, open skin wounds at the treatment location site, patients with neurological deficits related to acute back pain, pregnant women, individuals unable to take oral medications, temperature >38C, prisoners, those unable to consent, subjects under police custody, nursing home residents, non-English speaking patients.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
AEHN
Philadelphia, Pennsylvania, 19147
Beth Lynch
About this study
Official title: Osteopathic Manipulative Treatment Compared to Ibuprofen for the Treatment of Acute Low Back Pain in the Emergency Department: a Randomized Controlled Trial
Acute low back pain is the fifth most common presenting complaint to the emergency department, accounting for approximately 4.4% of annual visits. The treatment for acute low back pain is often NSAIDs or other analgesic medications. Osteopathic Manipulative Treatment (OMT) has been shown to be an effective treatment modality for acute low back pain, however, it's use in the emergency department setting is not well described. The adjunct of OMT has the potential to increase patient satisfaction, decrease length of stay and decrease the number of unnecessary prescription medications. We plan to investigate the use of OMT in the setting of acute complaints of low back pain in comparison to the use of nonsteroidal anti-inflammatory drugs (NSAIDs) as primary treatment modality. The study will be a non-blinded randomized-control trial and will take place in an academic tertiary care center in urban Philadelphia, PA over an approximate one-year timespan. We will utilize osteopathic-trained attending and resident physicians to perform the manipulation. Patients will be randomized into one of three treatment groups: appropriately dosed NSAID therapy alone, OMT in addition to NSAID therapy, or OMT alone. The primary outcome will be the difference in pain score before and after treatment using a VAS scale. Secondary outcomes will include patient and physician satisfaction immediately following treatment. Results will be shared by means of publication to the osteopathic and allopathic communities.
Read the detailed description
The goal of this study is to describe the efficacy of Osteopathic Manipulative Treatment (OMT) compared to NSAIDs in decreasing pain in adults with acute low back pain in the emergency department (ED). This study would provide an additional novel adjunct for pain management of painful procedures in the emergency department. Currently in the emergency department the complaint of low back pain comprises 4.4% of visits annually and is an area of patient dissatisfaction surrounding the pain management.
The primary aims of this project will be measure the level of pain pre and post procedure in adults receiving ibuprofen (NSAID), OMT, or OMT/ibuprofen for low back pain. Secondary aims include patient and physician post procedure satisfaction scores, length of stay in ED.
AIM 1: Measure the level of pain pre and post procedures in adults receiving ibuprofen, OMT, or OMT/Ibuprofen. Hypothesis: The level of pain for patients receiving OMT will be decreased to a greater extent that those receiving only NSAIDs for low back pain.
AIM2: Measure the patient and physician satisfaction with the adjunct of OMT in regard to ability to manage pain based on satisfaction scores from questionnaire. Hypothesis: There will be greater satisfaction in the patients receiving OMT and OMT/NSAIDs than those receiving only OMT alone.
This study will be a prospective, randomized- controlled trial of patients with acute low back pain in the ED of an urban, tertiary, academic medical center. Subjects will be randomized to one of three groups: Ibuprofen (800 mg), Ibuprofen (800 mg)/OMT, or OMT only for the treatment of acute low back pain
Recruitment Methods
The research associates as well as the health care team (both residents and attending physicians) will screen patients who present to the ED with the chief complaint of back pain and may qualify for the study. Research associates will use the electronic medical record for screening, and they will be in charge of informed consent, enrollment, as well as data collection. The research study team (osteopathic emergency physicians) will be in charge of performing the OMT.
Procedures Involved in the Research
Initial medical assessment will be made in accordance with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patient meets eligibility criteria, then they will be approached by a research associate for enrollment in the study and will obtain informed consent.
After informed consent, the patient will fill out a pre intervention 100 mm VAS baseline pain scale. The patient will be randomized to one of the three treatment arms; NSAID (ibuprofen), OMT/NSAID (ibuprofen), or OMT alone by using a randomization scheme generated using the web site Randomization.com (http://www.randomization.com).
Once randomized, subjects in the NSAID arm will be assessed using a VAS prior to medication administration. They will then be given 800 mg of ibuprofen and subjects' pain will be assessed using the VAS at 45 minutes after NSAID administration. Subjects in the NSAID/OMT arm will be assessed using a VAS prior to medication administration and OMT. They will then be given 800 mg of ibuprofen and within 10 minutes will receive OMT. The subject's pain will be assessed using the VAS at 45 minutes after NSAID administration and completion of OMT. The OMT only arm will be assessed using a VAS prior to any OMT. OMT will then be performed and subjects' pain will be assessed using the VAS at 45 minutes after OMT is completed. The method of OMT will be left to the discretion of the treating physician, but will be recorded in the data collection sheet.
The subject's clinical data (refer to data management) will be entered into a standardized data collection form. Study will end 45-60 minutes after randomized intervention. Once the procedure is complete subjects will fill out a post procedure satisfaction questionnaire. The physician will also fill out a post procedure questionnaire.
- Conditions
- Low Back Pain
- Being tested
- Ibuprofen, Osteopathic manipulative treatment
- 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.
IbuprofenDrug
Also called Motrin, Advil
Weight based ibuprofen dosing
Osteopathic manipulative treatmentProcedure or surgery
Also called OMT, OMM
Low velocity osteopathic manipulative treatment
| Study group | Role | What they receive |
|---|---|---|
| NSAID | Active comparator | Ibuprofen, 800 mg, one time dose Receives: Drug: Ibuprofen |
| OMT/NSAID | Active comparator | Ibuprofen, 800 mg, one time dose Receives: Drug: Ibuprofen; Procedure: Osteopathic manipulative treatment |
| OMT alone | Active comparator | low velocity osteopathic manipulative medicine Receives: Procedure: Osteopathic manipulative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Difference in pain score before and after treatment using a Visual Analog Scale (VAS) scale (minimum 1, maximum 10, 10 being the worst)
Measured: 45 minutes
Secondary outcomes (2)
Patient Satisfaction
Patient satisfaction immediately following treatment with questionnaire
Measured: 45 minutes
Physician Satisfaction
Physician satisfaction immediately following treatment with questionnaire
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start19 Feb 2020
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Stobar-Gallagher, Albert Einstein Healthcare Network
- Investigators
- Joseph Herres, DO, Study director, Einstein Healthcare NetworkMegan Stobart-Gallagher, DO, Principal investigator, Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129437
- Sponsor's protocol ID
- IRB2019172
- Status last verified
- Nov 2022
- First submitted
- 11 Oct 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment Compared to Ibuprofen for the Treatment of Acute Low Back Pain in the Emergency Department: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04129437
- Acronym / sponsor ID
- IRB2019172
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 16 Oct 2019 (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.
Acute low back pain is the fifth most common presenting complaint to the emergency department, accounting for approximately 4.4% of annual visits. The treatment for acute low back pain is often NSAIDs or other analgesic medications. Osteopathic Manipulative Treatment (OMT) has been shown to be an effective treatment modality for acute low back pain, however, it's use in the emergency department setting is not well described. The adjunct of OMT has the potential to increase patient satisfaction, decrease length of stay and decrease the number of unnecessary prescription medications. We plan to investigate the use of OMT in the setting of acute complaints of low back pain in comparison to the use of nonsteroidal anti-inflammatory drugs (NSAIDs) as primary treatment modality. The study will be a non-blinded randomized-control trial and will take place in an academic tertiary care center in urban Philadelphia, PA over an approximate one-year timespan. We will utilize osteopathic-trained attending and resident physicians to perform the manipulation. Patients will be randomized into one of three treatment groups: appropriately dosed NSAID therapy alone, OMT in addition to NSAID therapy, or OMT alone. The primary outcome will be the difference in pain score before and after treatment using a VAS scale. Secondary outcomes will include patient and physician satisfaction immediately following treatment. Results will be shared by means of publication to the osteopathic and allopathic communities.
Detailed description
The goal of this study is to describe the efficacy of Osteopathic Manipulative Treatment (OMT) compared to NSAIDs in decreasing pain in adults with acute low back pain in the emergency department (ED). This study would provide an additional novel adjunct for pain management of painful procedures in the emergency department. Currently in the emergency department the complaint of low back pain comprises 4.4% of visits annually and is an area of patient dissatisfaction surrounding the pain management.
The primary aims of this project will be measure the level of pain pre and post procedure in adults receiving ibuprofen (NSAID), OMT, or OMT/ibuprofen for low back pain. Secondary aims include patient and physician post procedure satisfaction scores, length of stay in ED.
AIM 1: Measure the level of pain pre and post procedures in adults receiving ibuprofen, OMT, or OMT/Ibuprofen. Hypothesis: The level of pain for patients receiving OMT will be decreased to a greater extent that those receiving only NSAIDs for low back pain.
AIM2: Measure the patient and physician satisfaction with the adjunct of OMT in regard to ability to manage pain based on satisfaction scores from questionnaire. Hypothesis: There will be greater satisfaction in the patients receiving OMT and OMT/NSAIDs than those receiving only OMT alone.
This study will be a prospective, randomized- controlled trial of patients with acute low back pain in the ED of an urban, tertiary, academic medical center. Subjects will be randomized to one of three groups: Ibuprofen (800 mg), Ibuprofen (800 mg)/OMT, or OMT only for the treatment of acute low back pain
Recruitment Methods
The research associates as well as the health care team (both residents and attending physicians) will screen patients who present to the ED with the chief complaint of back pain and may qualify for the study. Research associates will use the electronic medical record for screening, and they will be in charge of informed consent, enrollment, as well as data collection. The research study team (osteopathic emergency physicians) will be in charge of performing the OMT.
Procedures Involved in the Research
Initial medical assessment will be made in accordance with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patient meets eligibility criteria, then they will be approached by a research associate for enrollment in the study and will obtain informed consent.
After informed consent, the patient will fill out a pre intervention 100 mm VAS baseline pain scale. The patient will be randomized to one of the three treatment arms; NSAID (ibuprofen), OMT/NSAID (ibuprofen), or OMT alone by using a randomization scheme generated using the web site Randomization.com (http://www.randomization.com).
Once randomized, subjects in the NSAID arm will be assessed using a VAS prior to medication administration. They will then be given 800 mg of ibuprofen and subjects' pain will be assessed using the VAS at 45 minutes after NSAID administration. Subjects in the NSAID/OMT arm will be assessed using a VAS prior to medication administration and OMT. They will then be given 800 mg of ibuprofen and within 10 minutes will receive OMT. The subject's pain will be assessed using the VAS at 45 minutes after NSAID administration and completion of OMT. The OMT only arm will be assessed using a VAS prior to any OMT. OMT will then be performed and subjects' pain will be assessed using the VAS at 45 minutes after OMT is completed. The method of OMT will be left to the discretion of the treating physician, but will be recorded in the data collection sheet.
The subject's clinical data (refer to data management) will be entered into a standardized data collection form. Study will end 45-60 minutes after randomized intervention. Once the procedure is complete subjects will fill out a post procedure satisfaction questionnaire. The physician will also fill out a post procedure questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSAID | Active comparator | Drug: IbuprofenIbuprofen, 800 mg, one time dose |
| OMT/NSAID | Active comparator | Drug: Ibuprofen, Procedure: Osteopathic manipulative treatmentIbuprofen, 800 mg, one time dose |
| OMT alone | Active comparator | Procedure: Osteopathic manipulative treatmentlow velocity osteopathic manipulative medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients 18 years of age or older with the chief complaint of acute low back pain defined as symptom duration no longer than four weeks prior to ED presentation and having clinical findings of somatic dysfunction (muscle edema, erythema, bogginess, hypertonic muscles, asymmetry of tissue, pain with movement, severe/sharp tenderness).
Key exclusion criteria (1 listed)
- Patients will be excluded if they previously participated in the study, history of gastrointestinal bleed, allergies to NSAIDs, NSAID use 4 hours prior to arrival, history of or concern for spinal column fracture, current diagnosis of active malignancy or metastatic cancer, open skin wounds at the treatment location site, patients with neurological deficits related to acute back pain, pregnant women, individuals unable to take oral medications, temperature >38C, prisoners, those unable to consent, subjects under police custody, nursing home residents, non-English speaking patients.
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 |
|---|---|---|
| IbuprofenAlso: Motrin, AdvilWeight based ibuprofen dosing | Drug | NSAID, OMT/NSAID |
| Osteopathic manipulative treatmentAlso: OMT, OMMLow velocity osteopathic manipulative treatment | Procedure or surgery | OMT alone, OMT/NSAID |
Primary outcome
Pain score
Time frame: 45 minutes
Difference in pain score before and after treatment using a Visual Analog Scale (VAS) scale (minimum 1, maximum 10, 10 being the worst)
2 secondary outcomes
Patient Satisfaction
Time frame: 45 minutes
Physician Satisfaction
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Joseph Herres, DO study director
Einstein Healthcare Network
Megan Stobart-Gallagher, DO principal investigator
Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen and Osteopathic manipulative treatment in people with Low Back Pain, run by Albert Einstein Healthcare Network 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 1 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: status not confirmed, as of the sponsor's last update on 7 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Stobart-Gallagher, DO (985-630-0193, megan.stobart-gallagher@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 45 minutes). 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 7 Nov 2022.