Low Back Pain, MechanicalPhase 4NCT06064175
"Management of Low Back Pain in the Emergency Department With Different Analgesic Dosages"
A Phase 4 study testing Ibuprofen 400 mg and Ibuprofen 800 mg in people with Low Back Pain, Mechanical and Ibuprofen, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The Management of Low Back Pain in the Emergency Department Worldwide, low back pain is one of the most prevalent musculoskeletal disorders, and it constitutes one of the primary complaints in emergency departments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical, Ibuprofen, Analgesia
- What is being tested?
- Ibuprofen 400 mg and Ibuprofen 800 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and above but under 65 years old.
- Patients willing to participate in the study.
- Patients with acute pain lasting less than two weeks.
- Non-traumatic pain.
- Patients without radicular back pain.
- Patients scoring more than 5 points on the 24-item validated Roland Morris Disability Questionnaire (RMDQ).
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- Patients marking more than 4 on the Numeric Pain Rating Scale (NRS).
- Patients deemed appropriate for the study by an emergency medicine specialist based on history and physical examination.
- Patients in whom other differential diagnoses are not primarily considered.
Who cannot join
- - Patients aged below 18 and above 65.
- Patients who decline to participate in the study.
- Patients with vital signs outside normal limits.
- Patients with a history of adverse reactions to ibuprofen.
- Patients unable to determine their pain intensity on the NRS.
- Pregnant individuals.
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- Individuals with a history of heart disease and hypertension.
- Individuals with advanced systemic diseases.
- Patients with malignancies.
- Patients with chronic liver disease.
- Individuals using neuro-psychiatric drugs with sedative and analgesic effects.
- Individuals with a history of psychological and neurological diseases.
- Patients who used analgesics within 6 hours before examination.
- Patients with pain lasting more than two weeks.
- Traumatic cases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Randomized Double-Blind Comparison of Analgesic Efficacy Between Intravenous Forms of Ibuprofen 400 and Ibuprofen 800 mg in Acute Mechanical Low Back Pain in the Emergency Department
The Management of Low Back Pain in the Emergency Department Worldwide, low back pain is one of the most prevalent musculoskeletal disorders, and it constitutes one of the primary complaints in emergency departments. A review of the literature reveals studies comparing ibuprofen to various agents (such as paracetamol, nimesulide, acetaminophen), and these studies suggest the use of ibuprofen due to its similar or superior efficacy and its safety profile. However, there is a lack of randomized controlled double-blind comparisons between the commonly recommended single doses of ibuprofen, which are 400 mg and 800 mg. Therefore, the objective of our planned study is to compare the analgesic efficacy of ibuprofen in the forms of 400 mg and 800 mg, which can be administered as a single dose, in the treatment of acute mechanical low back pain, as recommended in all guidelines.
Read the detailed description
The worldwide prevalence of low back pain makes it one of the most common musculoskeletal disorders, and it ranks among the primary complaints in emergency departments. Literature review reveals studies comparing ibuprofen to various agents (such as paracetamol, nimesulide, acetaminophen), and these studies suggest the use of ibuprofen due to its similar or superior efficacy and its safety profile. However, there is a lack of randomized controlled double-blind comparisons between the commonly recommended single doses of ibuprofen, which are 400 mg and 800 mg. Therefore, the objective of our planned study is to compare the analgesic efficacy of ibuprofen in the forms of 400 mg and 800 mg, which can be administered as a single dose, in the treatment of acute mechanical low back pain, as recommended in all guidelines.
The expected benefit of the research is to determine whether the analgesic effectiveness of ibuprofen 400 mg is equivalent to that of 800 mg, thereby potentially reducing the unnecessary use of higher doses of NSAIDs. Alternatively, if the 800 mg parenteral form proves to be more effective, it may suggest recommending the standard single-dose use of 800 mg for analgesia in acute mechanical low back pain.
The research is designed as a prospective, randomized-double-blind, single-center study.
The study is divided into two arms, labeled as Arm 1 and Arm 2. Randomization will be conducted by the principal investigator. For patients who agree to participate in the study, pre-assigned medications will be administered using a computer program. The relevant medications will be numbered and placed in envelopes within this computer program, which will then be labeled as Treatment 1 and Treatment 2. The randomly selected medication (Treatment 1 or Treatment 2) will be administered by a nurse, and the administering nurse will subsequently be separated from the patient's treatment and follow-up.
Upon the arrival of a patient who meets the inclusion criteria, the informed consent form will be obtained. The patient will be assigned to the research arm according to the randomization scheme. Research arms are divided into Arm 1 and Arm 2. In both arms, ibuprofen solutions of 400 mg/4 ml and 800 mg/8 ml will be prepared and administered as rapid infusions over 10 minutes in 150 ml of saline solution (0.09% NaCl).
After the patient arrives, the attending physician will inform the nurse that a patient is being enrolled in the study. The nurse will prepare the injector as specified in the order. The patient will be asked to mark their pain level on a 10-point NRS before injection. They will be asked to mark their pain level again at 15, 30, 60, and 120 minutes. If there is no relief in pain level by the 30th minute or if the pain level does not decrease to the desired level (NRS>3) at 60 or 120 minutes, rescue medication will be administered.
The rescue medication protocol will involve tramadol citrate 100 mg. It will be administered as an intravenous infusion in 500 cc of normal saline over 20-30 minutes to minimize possible side effects and ensure controlled delivery.
If the patient wishes to withdraw from the study during this follow-up period or if any complications arise, they will be withdrawn from the study.
- Conditions
- Low Back Pain, Mechanical, Ibuprofen, Analgesia, Pain Management
- Being tested
- Ibuprofen 400 mg, Ibuprofen 800 mg
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mgDrug
Patients will receive ibuprofen 400 mg/4 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl).
Ibuprofen 800 mgDrug
Patients will receive ibuprofen 800 mg/8 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl).
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen 400 mg-group 1 | Experimental | Patients will receive ibuprofen 400 mg/4 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl). Receives: Drug: Ibuprofen 400 mg |
| Ibuprofen 800 mg-group 2 | Experimental | Patients will receive ibuprofen 800 mg/8 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl). Receives: Drug: Ibuprofen 800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Numeric Rating Scale
Measured: 15., 30., 60. and 120. minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Dönmez, Ankara City Hospital Bilkent
- Investigators
- SAFA DÖNMEZ, M.D., Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064175
- Sponsor's protocol ID
- Low Back Pain Analgesic
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have a data sharing plan for this study; however, the data set will be shared upon publication with the journal that has been submitted to.
Publications
Oliveira IS, Vanin AA, Pena Costa LO, Medeiros FC, Ananias Oshima RK, Inacio AA, Matos da Cunha TA, Palomo AS, Fukuda TY, de Freitas DG, Benvenuto F, Menezes Costa LDC. Profile of Patients With Acute Low Back Pain Who Sought Emergency Departments: A Cross-sectional Study. Spine (Phila Pa 1976). 2020 Mar 1;45(5):E296-E303. doi: 10.1097/BRS.0000000000003253.
PubMed 32045404Ostojic P, Radunovic G, Lazovic M, Tomanovic-Vujadinovic S. Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study. Acta Reumatol Port. 2017 Jan-Mar;42(1):18-25.
PubMed 27978532Friedman BW, Irizarry E, Chertoff A, Feliciano C, Solorzano C, Zias E, Gallagher EJ. Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Low Back Pain: An Emergency Department-based Randomized Study. Acad Emerg Med. 2020 Mar;27(3):229-235. doi: 10.1111/acem.13898. Epub 2020 Jan 7.
PubMed 31811673Pohjolainen T, Jekunen A, Autio L, Vuorela H. Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide: results of a randomized, double-blind comparative trial versus ibuprofen. Spine (Phila Pa 1976). 2000 Jun 15;25(12):1579-85. doi: 10.1097/00007632-200006150-00019.
PubMed 10851109Tuzun F, Unalan H, Oner N, Ozguzel H, Kirazli Y, Icagasioglu A, Kuran B, Tuzun S, Basar G. Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain. Joint Bone Spine. 2003 Sep;70(5):356-61. doi: 10.1016/s1297-319x(03)00075-7.
PubMed 14563464
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Double-Blind Comparison of Analgesic Efficacy Between Intravenous Forms of Ibuprofen 400 and Ibuprofen 800 mg in Acute Mechanical Low Back Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT06064175
- Acronym / sponsor ID
- Low Back Pain Analgesic
- Conditions
- Low Back Pain, Mechanical, Ibuprofen, Analgesia, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 3 Oct 2023 (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 Management of Low Back Pain in the Emergency Department Worldwide, low back pain is one of the most prevalent musculoskeletal disorders, and it constitutes one of the primary complaints in emergency departments. A review of the literature reveals studies comparing ibuprofen to various agents (such as paracetamol, nimesulide, acetaminophen), and these studies suggest the use of ibuprofen due to its similar or superior efficacy and its safety profile. However, there is a lack of randomized controlled double-blind comparisons between the commonly recommended single doses of ibuprofen, which are 400 mg and 800 mg. Therefore, the objective of our planned study is to compare the analgesic efficacy of ibuprofen in the forms of 400 mg and 800 mg, which can be administered as a single dose, in the treatment of acute mechanical low back pain, as recommended in all guidelines.
Detailed description
The worldwide prevalence of low back pain makes it one of the most common musculoskeletal disorders, and it ranks among the primary complaints in emergency departments. Literature review reveals studies comparing ibuprofen to various agents (such as paracetamol, nimesulide, acetaminophen), and these studies suggest the use of ibuprofen due to its similar or superior efficacy and its safety profile. However, there is a lack of randomized controlled double-blind comparisons between the commonly recommended single doses of ibuprofen, which are 400 mg and 800 mg. Therefore, the objective of our planned study is to compare the analgesic efficacy of ibuprofen in the forms of 400 mg and 800 mg, which can be administered as a single dose, in the treatment of acute mechanical low back pain, as recommended in all guidelines.
The expected benefit of the research is to determine whether the analgesic effectiveness of ibuprofen 400 mg is equivalent to that of 800 mg, thereby potentially reducing the unnecessary use of higher doses of NSAIDs. Alternatively, if the 800 mg parenteral form proves to be more effective, it may suggest recommending the standard single-dose use of 800 mg for analgesia in acute mechanical low back pain.
The research is designed as a prospective, randomized-double-blind, single-center study.
The study is divided into two arms, labeled as Arm 1 and Arm 2. Randomization will be conducted by the principal investigator. For patients who agree to participate in the study, pre-assigned medications will be administered using a computer program. The relevant medications will be numbered and placed in envelopes within this computer program, which will then be labeled as Treatment 1 and Treatment 2. The randomly selected medication (Treatment 1 or Treatment 2) will be administered by a nurse, and the administering nurse will subsequently be separated from the patient's treatment and follow-up.
Upon the arrival of a patient who meets the inclusion criteria, the informed consent form will be obtained. The patient will be assigned to the research arm according to the randomization scheme. Research arms are divided into Arm 1 and Arm 2. In both arms, ibuprofen solutions of 400 mg/4 ml and 800 mg/8 ml will be prepared and administered as rapid infusions over 10 minutes in 150 ml of saline solution (0.09% NaCl).
After the patient arrives, the attending physician will inform the nurse that a patient is being enrolled in the study. The nurse will prepare the injector as specified in the order. The patient will be asked to mark their pain level on a 10-point NRS before injection. They will be asked to mark their pain level again at 15, 30, 60, and 120 minutes. If there is no relief in pain level by the 30th minute or if the pain level does not decrease to the desired level (NRS>3) at 60 or 120 minutes, rescue medication will be administered.
The rescue medication protocol will involve tramadol citrate 100 mg. It will be administered as an intravenous infusion in 500 cc of normal saline over 20-30 minutes to minimize possible side effects and ensure controlled delivery.
If the patient wishes to withdraw from the study during this follow-up period or if any complications arise, they will be withdrawn from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 400 mg-group 1 | Experimental | Drug: Ibuprofen 400 mgPatients will receive ibuprofen 400 mg/4 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl). |
| Ibuprofen 800 mg-group 2 | Experimental | Drug: Ibuprofen 800 mgPatients will receive ibuprofen 800 mg/8 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 and above but under 65 years old.
- Patients willing to participate in the study.
- Patients with acute pain lasting less than two weeks.
- Non-traumatic pain.
- Patients without radicular back pain.
Key exclusion criteria (15 listed)
- - Patients aged below 18 and above 65.
- Patients who decline to participate in the study.
- Patients with vital signs outside normal limits.
- Patients with a history of adverse reactions to ibuprofen.
- Patients unable to determine their pain intensity on the NRS.
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 |
|---|---|---|
| Ibuprofen 400 mgPatients will receive ibuprofen 400 mg/4 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl). | Drug | Ibuprofen 400 mg-group 1 |
| Ibuprofen 800 mgPatients will receive ibuprofen 800 mg/8 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl). | Drug | Ibuprofen 800 mg-group 2 |
Primary outcome
NRS
Time frame: 15., 30., 60. and 120. minutes
Numeric Rating Scale
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 3 Oct 2023.
- Background: PubMed 32045404Oliveira IS, Vanin AA, Pena Costa LO, Medeiros FC, Ananias Oshima RK, Inacio AA, Matos da Cunha TA, Palomo AS, Fukuda TY, de Freitas DG, Benvenuto F, Menezes Costa LDC. Profile of Patients With Acute Low Back Pain Who Sought Emergency Departments: A Cross-sectional Study. Spine (Phila Pa 1976). 2020 Mar 1;45(5):E296-E303. doi: 10.1097/BRS.0000000000003253.
- Background: PubMed 27978532Ostojic P, Radunovic G, Lazovic M, Tomanovic-Vujadinovic S. Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study. Acta Reumatol Port. 2017 Jan-Mar;42(1):18-25.
- Background: PubMed 31811673Friedman BW, Irizarry E, Chertoff A, Feliciano C, Solorzano C, Zias E, Gallagher EJ. Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Low Back Pain: An Emergency Department-based Randomized Study. Acad Emerg Med. 2020 Mar;27(3):229-235. doi: 10.1111/acem.13898. Epub 2020 Jan 7.
- Background: PubMed 10851109Pohjolainen T, Jekunen A, Autio L, Vuorela H. Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide: results of a randomized, double-blind comparative trial versus ibuprofen. Spine (Phila Pa 1976). 2000 Jun 15;25(12):1579-85. doi: 10.1097/00007632-200006150-00019.
- Background: PubMed 14563464Tuzun F, Unalan H, Oner N, Ozguzel H, Kirazli Y, Icagasioglu A, Kuran B, Tuzun S, Basar G. Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain. Joint Bone Spine. 2003 Sep;70(5):356-61. doi: 10.1016/s1297-319x(03)00075-7.
- Individual participant dataSharing planned: No. We do not have a data sharing plan for this study; however, the data set will be shared upon publication with the journal that has been submitted to.
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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.
SAFA DÖNMEZ, M.D. principal investigator
Ankara City Hospital Bilkent
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 400 mg and Ibuprofen 800 mg in people with Low Back Pain, Mechanical and Ibuprofen, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 9 inclusion and 15 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 Oct 2023. 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 Turkey (Türkiye). 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?
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?
NRS (time frame: 15., 30., 60. and 120. minutes). 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 NCT06064175, which also lists 5 linked publications.
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 Oct 2023.