Radiculopathy LumbarPhase 4NCT05571046
Glucocorticoid Injection in Patients With Lumbar Radicular Pain
A Phase 4 study testing Glucocorticoids in people with Radiculopathy Lumbar, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. The investigators also aimed to determine the effects on electrophysiological findings. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy Lumbar
- What is being tested?
- Glucocorticoids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 26 Oct 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 between 18 and 65 years old with acute (less than 6 weeks) lumbar radicular pain due to intervertebral disc herniation.
- Neurological findings such as sensory, motor and reflex abnormality matching the L4, L5 or S1 nerve distribution.
- Patients who confirmed to have root compression (radiculopathy) by electrophysiological investigations.
Who cannot join
- Contraindication for steroid usage (acute infection, uncontrolled diabetes and hypertension, severe cardiac failure), hypersensitivity to steroids
- Acute trauma
- Inflammatory low back pain
- Indications for neurosurgery (pronounced motor weakness or cauda equina syndrome)
- Lumbar spinal stenosis
- History of back surgery, history of steroid injection in the last 3 months
- Pregnancy, lactation
- Malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain
The purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
Read the detailed description
Low back pain is an important health problem that causes difficulties in daily living activities, loss of work performance and disability. Some patients with low back pain have radicular symptoms due to intervertebral disc herniation. Lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution.
The pathophysiology of radiculopathy is related to compression of the nerve, as well as the local release of inflammatory cytokines. Systemic corticosteroids have been used for treatment of lumbar radicular pain for a long time. The effects of corticosteroids are related to their anti-inflammatory effects, which may help reduce swelling and related compression on the affected nerve. Corticosteroids can be used systemically (i.e. oral, intravenous, or intramuscular routes) or administered directly into spinal structures through injections.
In the current study, the investigators aimed to demonstrate the efficacy of intramuscular betamethasone injection on pain, disability and health related quality of life in patients with lumbar radicular pain due to disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
- Conditions
- Radiculopathy Lumbar
- Being tested
- Glucocorticoids, Placebo
- Keywords
- glucocorticoid, radicular pain, lumbar radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Also called Diprospan
Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)
PlaceboOther
Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid injection | Active comparator | Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate) Receives: Drug: Glucocorticoids |
| Placebo injection | Placebo comparator | Intramuscular saline (%0.9 isotonic sodium chloride) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar radicular pain
Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Measured: Week 1
Lumbar radicular pain
Visual analog
(VAS, min-max values: 0-100, higher scores mean a worse outcome)
Measured: Month 1
Lumbar radicular pain
Visual analog
(VAS, min-max values: 0-100, higher scores mean a worse outcome)
Measured: Month 3
Disability
Oswestry Disability Index
(ODI, min-max values: 0-100, higher scores mean a worse outcome)
Measured: Month 1
Disability
Oswestry Disability Index
(ODI, min-max values: 0-100, higher scores mean a worse outcome)
Measured: Month 3
Health related quality of Life
Nottingham Health Profile
(NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Measured: Month 1
Health related quality of Life
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Measured: Month 3
Secondary outcomes (4)
Electrophysiological evaluation (Sensory NCS)
Sensory nerve conduction study (m/s)
Measured: Month 1
Electrophysiological evaluation (Motor NCS)
Motor nerve conduction study (m/s)
Measured: Month 1
Electrophysiological evaluation (F wave)
F wave (m/s)
Measured: Month 1
Electrophysiological evaluation (H reflex)
H reflex (m/s)
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jun 2022
- Primary completion12 Oct 2023
- Study completion26 Oct 2023
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 Radiculopathy LumbarStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Basaran, Cukurova University
- Investigators
- Sibel Basaran, MD, Prof, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571046
- Sponsor's protocol ID
- Cukurova14980
- Other IDs
- TTU-2022-14980
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boga Vijdan E, Basaran S, Balal M. Efficacy of intramuscular glucocorticoid injection in patients with lumbar radicular pain: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):650. doi: 10.1186/s12891-025-08897-1.
PubMed 40616084
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT05571046
- Acronym / sponsor ID
- Cukurova14980
- Conditions
- Radiculopathy Lumbar
- Keywords
- glucocorticoid, radicular pain, lumbar radiculopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 7 Oct 2022 (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 purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
Detailed description
Low back pain is an important health problem that causes difficulties in daily living activities, loss of work performance and disability. Some patients with low back pain have radicular symptoms due to intervertebral disc herniation. Lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution.
The pathophysiology of radiculopathy is related to compression of the nerve, as well as the local release of inflammatory cytokines. Systemic corticosteroids have been used for treatment of lumbar radicular pain for a long time. The effects of corticosteroids are related to their anti-inflammatory effects, which may help reduce swelling and related compression on the affected nerve. Corticosteroids can be used systemically (i.e. oral, intravenous, or intramuscular routes) or administered directly into spinal structures through injections.
In the current study, the investigators aimed to demonstrate the efficacy of intramuscular betamethasone injection on pain, disability and health related quality of life in patients with lumbar radicular pain due to disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid injection | Active comparator | Drug: GlucocorticoidsIntramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate) |
| Placebo injection | Placebo comparator | Other: PlaceboIntramuscular saline (%0.9 isotonic sodium chloride) |
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 between 18 and 65 years old with acute (less than 6 weeks) lumbar radicular pain due to intervertebral disc herniation.
- Neurological findings such as sensory, motor and reflex abnormality matching the L4, L5 or S1 nerve distribution.
- Patients who confirmed to have root compression (radiculopathy) by electrophysiological investigations.
Key exclusion criteria (8 listed)
- Contraindication for steroid usage (acute infection, uncontrolled diabetes and hypertension, severe cardiac failure), hypersensitivity to steroids
- Acute trauma
- Inflammatory low back pain
- Indications for neurosurgery (pronounced motor weakness or cauda equina syndrome)
- Lumbar spinal stenosis
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 |
|---|---|---|
| GlucocorticoidsAlso: DiprospanIntramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day) | Drug | Glucocorticoid injection |
| PlaceboIntramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day) | Other | Placebo injection |
Primary outcome
Lumbar radicular pain
Time frame: Week 1
Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Lumbar radicular pain
Time frame: Month 1
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Lumbar radicular pain
Time frame: Month 3
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Disability
Time frame: Month 1
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Disability
Time frame: Month 3
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Health related quality of Life
Time frame: Month 1
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Health related quality of Life
Time frame: Month 3
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
4 secondary outcomes
Electrophysiological evaluation (Sensory NCS)
Time frame: Month 1
Electrophysiological evaluation (Motor NCS)
Time frame: Month 1
Electrophysiological evaluation (F wave)
Time frame: Month 1
Electrophysiological evaluation (H reflex)
Time frame: Month 1
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 1 Nov 2023.
- Derived from this study: PubMed 40616084Boga Vijdan E, Basaran S, Balal M. Efficacy of intramuscular glucocorticoid injection in patients with lumbar radicular pain: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):650. doi: 10.1186/s12891-025-08897-1.
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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.
Sibel Basaran, MD, Prof study director
Cukurova 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 Glucocorticoids in people with Radiculopathy Lumbar, run by Cukurova University 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 8 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 1 Nov 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. 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.
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?
Lumbar radicular pain (time frame: Week 1). The study lists 7 primary outcomes in all. 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 NCT05571046, 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 1 Nov 2023.