Low Back PainPhase 4PainNCT06932367
The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain
A Phase 4 study testing Dexketoprofen (KETAVEL 50 mg/2 ml) and Methylprednisolone (Corticosteroid) in people with Low Back Pain, run by Ali Gur at 1 site in Turkey (Türkiye).
Trial summary
Many methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).This… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Dexketoprofen (KETAVEL 50 mg/2 ml) and Methylprednisolone (Corticosteroid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 2 Jan 2025
- 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 over 18 and under 65 years.
- The patients who presented to the emergency department with acute non-traumatic low back pain.
- Voluntarily agreed to participate in the study.
Who cannot join
- The patients who had used analgesics within the last six hours;
- Who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain,
- Who has a history of dexketoprofen-related gastrointestinal bleeding or perforation, referred pain, neoplastic pain, a history of allergies to medications used in the study (methylprednisolone and dexketoprofen), or vision problems;
- Who indicated a pain intensity of 3 cm or less on the 10-cm VAS scale line at the time of their presentation to the emergency department; pregnant and breastfeeding women;
- The patients who were illiterate.
Trial locations and contacts
1 site in 1 country.
About this study
Many methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).This prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group D) and those receiving dexketoprofen + methylprednisolone treatment (Group DM). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.
- Conditions
- Low Back Pain
- Being tested
- Dexketoprofen (KETAVEL 50 mg/2 ml), Methylprednisolone (Corticosteroid)
- Keywords
- Low back pain, Dexketoprofen, Methylprednisolone, Visual Analog Scale, Oswestry Disability Index
- 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.
Dexketoprofen (KETAVEL 50 mg/2 ml)Drug
Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group 1) and those receiving dexketoprofen + methylprednisolone treatment (Group 2). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.
Methylprednisolone (Corticosteroid)Combination product
Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group 1) and those receiving dexketoprofen + methylprednisolone treatment (Group 2). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 was the patients who was receiving intravenous dexketoprofen treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48 Receives: Drug: Dexketoprofen (KETAVEL 50 mg/2 ml) |
| Group 2 | Active comparator | Group 2 was the patients who was receiving intravenous dexketoprofen combined with methylprednisolone treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Receives: Combination Product: Methylprednisolone (Corticosteroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) score
The primary outcome of the study was the pain scores of the groups according to the Visual Analog Scale (VAS) scores. Lower VAs score below 4 is assigned as the lower pain value of the participants, whereas, higer vaslus of VAS score close to 10 accepted as higher pain value described from the participants
Measured: 48 hours
Secondary outcomes (1)
Oswestry Disability Index (ODI)
The secondary outcome was the effect of dexketoprofen alone and in combination with methylprednisolone on low back pain-related disability, according to the Oswestry Disability Index (ODI)scores.
While interpreting the ODI score, the the scores are considered as:
0% to 20% - minimal disability 20% to 40% - moderate disability 40% to 60% - severe disability 60% to 80% - crippled 80% to 100% - bed bound (or exaggerating symptoms).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Aug 2021
- Primary completion1 Aug 2022
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Gur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Gur, Ataturk University
- Investigators
- Mehmet Meral Ataturk University Medical Faculty, Emergency Department, M.D., Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932367
- Sponsor's protocol ID
- B.30.2.ATA0.01.00/286
- Other IDs
- TTU-2021-9373
- Acronym
- Pain
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author, upon reasonable request.
Publications
Meral M, Gur A. A comparative study on the efficacy of dexketoprofen and methylprednisolone in the treatment of acute low back pain. BMC Emerg Med. 2025 Aug 5;25(1):147. doi: 10.1186/s12873-025-01276-y.
PubMed 40765043
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT06932367
- Acronym / sponsor ID
- Pain / B.30.2.ATA0.01.00/286
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Dexketoprofen, Methylprednisolone, Visual Analog Scale, Oswestry Disability Index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ali GurUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 17 Apr 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.
Many methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).This prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group D) and those receiving dexketoprofen + methylprednisolone treatment (Group DM). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)Group 1 was the patients who was receiving intravenous dexketoprofen treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48 |
| Group 2 | Active comparator | Combination Product: Methylprednisolone (Corticosteroid)Group 2 was the patients who was receiving intravenous dexketoprofen combined with methylprednisolone treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged over 18 and under 65 years.
- The patients who presented to the emergency department with acute non-traumatic low back pain.
- Voluntarily agreed to participate in the study.
Key exclusion criteria (5 listed)
- The patients who had used analgesics within the last six hours;
- Who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain,
- Who has a history of dexketoprofen-related gastrointestinal bleeding or perforation, referred pain, neoplastic pain, a history of allergies to medications used in the study (methylprednisolone and dexketoprofen), or vision problems;
- Who indicated a pain intensity of 3 cm or less on the 10-cm VAS scale line at the time of their presentation to the emergency department; pregnant and breastfeeding women;
- The patients who were illiterate.
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 |
|---|---|---|
| Dexketoprofen (KETAVEL 50 mg/2 ml)Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group 1) and those receiving dexketoprofen + methylprednisolone treatment (Group 2). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48. | Drug | Group 1 |
| Methylprednisolone (Corticosteroid)Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group 1) and those receiving dexketoprofen + methylprednisolone treatment (Group 2). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48. | Combination product | Group 2 |
Primary outcome
Visual Analog Scale (VAS) score
Time frame: 48 hours
The primary outcome of the study was the pain scores of the groups according to the Visual Analog Scale (VAS) scores. Lower VAs score below 4 is assigned as the lower pain value of the participants, whereas, higer vaslus of VAS score close to 10 accepted as higher pain value described from the participants
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: 48 hours
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 17 Apr 2025.
- Derived from this study: PubMed 40765043Meral M, Gur A. A comparative study on the efficacy of dexketoprofen and methylprednisolone in the treatment of acute low back pain. BMC Emerg Med. 2025 Aug 5;25(1):147. doi: 10.1186/s12873-025-01276-y.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author, upon reasonable request.
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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.
Mehmet Meral Ataturk University Medical Faculty, Emergency Department, M.D. principal investigator
Ataturk University
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 Dexketoprofen (KETAVEL 50 mg/2 ml) and Methylprednisolone (Corticosteroid) in people with Low Back Pain, run by Ali Gur 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 3 inclusion and 5 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 17 Apr 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 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?
Visual Analog Scale (VAS) score (time frame: 48 hours). 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 NCT06932367, which also lists 1 linked publication.
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 17 Apr 2025.