Acute PainNCT06987578
OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
A study testing OMT vs. Ibruprofen in people with Acute Pain, run by St. Joseph's Regional Medical Center, New Jersey at 1 site in United States.
Trial summary
Patients 18 to 65 years old who present within 72 hours of onset pain will be considered for study enrollment. Patients with the acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included. Patients will be excluded based upon specific exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- OMT vs. Ibruprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 5 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 65 years old who present within 72 hours of onset pain will be considered for study enrollment. Patients with acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included, provided they sign the informed consent.
Who cannot join
- Failure to sign consent Focal neurological deficit (motor or sensory), or paresthesia
- Severe osteoporosis
- History of peptic ulcer disease
- Presentation requiring cardiac monitoring
- Fracture, dislocation, or joint instability at the area of symptoms
- Presentation after traumatic injury requiring C-collar placement prior to or subsequent to arrival
Show all 20Show fewer
- Cancer or malignancy of the head, neck, chest or back
- Allergy to aspirin or nonsteroidal anti-inflammatory drugs
- Cellulitis (skin infection) at the treatment site
- Pregnancy or currently breastfeeding
- History of renal impairment
- Cervical or lumbar radiculopathy
- Active illicit drug abuse or chronic alcohol use
- Chronic pain syndrome
- Daily opioid use
- Use of aspirin daily
- Use of antiplatelet or anticoagulant medications (clopidogrel, warfarin, dabigatran rivaroxaban, apixaban or other similar medications)
- Glasgow Coma Scale (GCS) less than 15 or altered mental status
- Prisoners presenting in police custody
- Use of any non-steroidal antiplatelet medications (NSAIDS) or administration of any non-pharmacological manipulation (Physical Therapy or OMT) within six hours prior to presentation.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's University Medical Cener
Paterson, New Jersey, 07503
About this study
Official title: Osteopathic Manipulative Treatment vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
Patients 18 to 65 years old who present within 72 hours of onset pain will be considered for study enrollment. Patients with the acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included. Patients will be excluded based upon specific exclusion criteria. After providing informed consent, patients will be randomized by block randomization to receive OMT or ibuprofen 400 mg, given orally.
Read the detailed description
Patients 18 to 65 years old who present withinj 72 hours of onset pain will be considered for study enrollment. Patients with acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included. Patients will be excluded based upon specific exclusion criteria. After providing informed consent, patients will be randomized by block randomization to receive OMT or ibuprofen 400 mg, given orally.
A unique patient code will be given to each patient to protect their privacy. A baseline pain score of an 11-point numeric rating scale (NRS-11) will be documented prior to the intervention. The OMT study group will receive 5 minutes of OMT treatment consisting of either or both myofascial release and muscle energy. The control group will only receive ibuprofen 400 mg in a single oral dose. At 30 and 60 minutes post intervention both groups will be asked to score their pain on the 11-point NRS scale from 0 to 10. At 60 minutes, each patient will also be asked to evaluate their perceived pain reduction on the 5-point pain reduction scale (PRS-5). A pain reduction of 50% or greater, on the NRS-11 scale, will be considered clinically significant. Additionally patients will be asked to assess whether they experienced any significant side effects, such as nausea, vomiting, epigastric pain, dizziness or worsening muscle soreness. If the patient's pain is not controlled by 60 minutes, patients will be offered rescue analgesia. The choice of analgesic will be left to the discretion of the provider, but will be recorded for analysis. Lastly, patient satisfaction and likability of treatment will be measured.
- Conditions
- Acute Pain
- Being tested
- OMT vs. Ibruprofen
- Keywords
- musculoskeletal pain
- Medical subject headings
- Acute Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMT vs. IbruprofenOther
OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
| Study group | Role | What they receive |
|---|---|---|
| OMT only | Other | THE OMT study group will receive 5 minutes of OMT treatment consisting of either or both myofascial release and muscle energy Receives: Other: OMT vs. Ibruprofen |
| ibuprofen or placebo | Placebo comparator | The control group will only receive ibuprofen 400mg in a single dose Receives: Other: OMT vs. Ibruprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease opiod use
Measured: 10/30/2022
OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
50% change in pain score on the NRS-11 pain scale, from time of randomization to 60 minutes post-randomization
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start11 Jul 2019
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Single group
- Model description
- block randomization OMT vs Standard treatment
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Regional Medical Center, New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Sponsor
- Investigators
- Loretta Hall, MBHA, Study director, St. Joseph's University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987578
- Sponsor's protocol ID
- PR#19-025
- Status last verified
- May 2025
- First submitted
- 17 Oct 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A unique code will replace a subject identifiers
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT06987578
- Acronym / sponsor ID
- PR#19-025
- Conditions
- Acute Pain
- Keywords
- musculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- St. Joseph's Regional Medical Center, New JerseyUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 23 May 2025 (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.
Patients 18 to 65 years old who present within 72 hours of onset pain will be considered for study enrollment. Patients with the acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included. Patients will be excluded based upon specific exclusion criteria. After providing informed consent, patients will be randomized by block randomization to receive OMT or ibuprofen 400 mg, given orally.
Detailed description
Patients 18 to 65 years old who present withinj 72 hours of onset pain will be considered for study enrollment. Patients with acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included. Patients will be excluded based upon specific exclusion criteria. After providing informed consent, patients will be randomized by block randomization to receive OMT or ibuprofen 400 mg, given orally.
A unique patient code will be given to each patient to protect their privacy. A baseline pain score of an 11-point numeric rating scale (NRS-11) will be documented prior to the intervention. The OMT study group will receive 5 minutes of OMT treatment consisting of either or both myofascial release and muscle energy. The control group will only receive ibuprofen 400 mg in a single oral dose. At 30 and 60 minutes post intervention both groups will be asked to score their pain on the 11-point NRS scale from 0 to 10. At 60 minutes, each patient will also be asked to evaluate their perceived pain reduction on the 5-point pain reduction scale (PRS-5). A pain reduction of 50% or greater, on the NRS-11 scale, will be considered clinically significant. Additionally patients will be asked to assess whether they experienced any significant side effects, such as nausea, vomiting, epigastric pain, dizziness or worsening muscle soreness. If the patient's pain is not controlled by 60 minutes, patients will be offered rescue analgesia. The choice of analgesic will be left to the discretion of the provider, but will be recorded for analysis. Lastly, patient satisfaction and likability of treatment will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- block randomization OMT vs Standard treatment
| Arm | Type | Receives |
|---|---|---|
| OMT only | Other | Other: OMT vs. IbruprofenTHE OMT study group will receive 5 minutes of OMT treatment consisting of either or both myofascial release and muscle energy |
| ibuprofen or placebo | Placebo comparator | Other: OMT vs. IbruprofenThe control group will only receive ibuprofen 400mg in a single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 to 65 years old who present within 72 hours of onset pain will be considered for study enrollment. Patients with acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included, provided they sign the informed consent.
Key exclusion criteria (20 listed)
- Failure to sign consent Focal neurological deficit (motor or sensory), or paresthesia
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 |
|---|---|---|
| OMT vs. IbruprofenOMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department | Other | OMT only, ibuprofen or placebo |
Primary outcome
decrease opiod use
Time frame: 10/30/2022
OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
Time frame: 60 minutes
50% change in pain score on the NRS-11 pain scale, from time of randomization to 60 minutes post-randomization
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 23 May 2025.
- Individual participant dataSharing planned: No. A unique code will replace a subject identifiers
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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.
Loretta Hall, MBHA study director
St. Joseph's University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMT vs. Ibruprofen in people with Acute Pain, run by St. Joseph's Regional Medical Center, New Jersey 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 20 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 23 May 2025. 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?
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?
decrease opiod use (time frame: 10/30/2022). 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?
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 23 May 2025.