Lumbar RadiculopathyPhase 4NCT03060434
Pentoxifylline and Lumbar Radiculopathy
A Phase 4 study testing Pentoxifylline Oral Tablet and Ibuprofen in people with Lumbar Radiculopathy and Lumbar Disc Herniation, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Disc Disease
- What is being tested?
- Pentoxifylline Oral Tablet and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jun 2018to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral lumbar radiculopathy
- Disc hernia confirming the diagnosis with radio-clinical concordance
Who cannot join
- Radicular deficit needing surgery
- Cauda equine syndrome
- Absence of radio-clinical concordance on MRI
- Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer …)
- Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol
- Pregnancy
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- Follow-up not possible
- Hepatic dysfunction
- History of drug abuse
- Current use of tramadol, codeine and/or morphine and its derivative
- Antidepressant use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy
The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy
Read the detailed description
Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.
- Being tested
- Pentoxifylline Oral Tablet, Ibuprofen
- Keywords
- pentoxifylline, Disc hernia, sciatica, lumbar radiculopathy
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement, Intervertebral disc disease, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline Oral TabletDrug
Also called Ibuprofen, Paracetamol, pregabalin
patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid
IbuprofenDrug
Also called Paracetamol, pregabalin
patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Ibuprofen Receives: Drug: Ibuprofen |
| Pentoxifylline | Experimental | Pentoxifylline oral tablets Receives: Drug: Pentoxifylline Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
Pain assessment by NRS
Measured: At day 15 (and Day 30)
Secondary outcomes (2)
Patient global impression of improvement scale
pain improvement scale from 1 to 7
Measured: day 15 and 30
Side effects
Reporting side effects by patient
Measured: Day 15 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jun 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies 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
- Crossover
- Model description
- Each patient will receive for 1 month: Ibuprofen 600 mg bid; Paracetamol 1g tid if needed; pregabalin 75 mg bid pentoxifylline 400 mg bid will be added for either the first or second 15 days (randomization)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon
- Investigators
- Joseph Maarrawi, MD, PhD, Principal investigator, Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060434
- Sponsor's protocol ID
- Pento-LR
- Status last verified
- May 2025
- First submitted
- 18 Feb 2017
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT03060434
- Acronym / sponsor ID
- Pento-LR
- Keywords
- pentoxifylline, Disc hernia, sciatica, lumbar radiculopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Feb 2017 (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 objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy
Detailed description
Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will receive for 1 month: Ibuprofen 600 mg bid; Paracetamol 1g tid if needed; pregabalin 75 mg bid pentoxifylline 400 mg bid will be added for either the first or second 15 days (randomization)
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: IbuprofenIbuprofen |
| Pentoxifylline | Experimental | Drug: Pentoxifylline Oral TabletPentoxifylline oral tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral lumbar radiculopathy
- Disc hernia confirming the diagnosis with radio-clinical concordance
Key exclusion criteria (11 listed)
- Radicular deficit needing surgery
- Cauda equine syndrome
- Absence of radio-clinical concordance on MRI
- Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer …)
- Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol
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 |
|---|---|---|
| Pentoxifylline Oral TabletAlso: Ibuprofen, Paracetamol, pregabalinpatient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid | Drug | Pentoxifylline |
| IbuprofenAlso: Paracetamol, pregabalinpatient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid | Drug | Control |
Primary outcome
Numerical rating scale (NRS)
Time frame: At day 15 (and Day 30)
Pain assessment by NRS
2 secondary outcomes
Patient global impression of improvement scale
Time frame: day 15 and 30
Side effects
Time frame: Day 15 and 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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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 Maarrawi, MD, PhD principal investigator
Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830
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 Pentoxifylline Oral Tablet and Ibuprofen in people with Lumbar Radiculopathy and Lumbar Disc Herniation, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 2 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 21 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 Lebanon. 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?
This study is still under way. Results are not available in the source record yet.
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?
Numerical rating scale (NRS) (time frame: At day 15 (and Day 30)). 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 21 May 2025.