Failed Back Surgery SyndromePhase 4NCT05324761
Management of Pain Associated With Failed Back Surgery Syndrome
A Phase 4 study testing Pregabalin 75mg and Gabapentin 300mg in people with Failed Back Surgery Syndrome, run by Al-Kindy College of Medicine at 1 site in Iraq.
Trial summary
Neuropathic pain is a common complication following different types of spine surgery making negative impact on health, along with life style changes and management, many neurologist prescribed either Pregabalin or Gabapentin to manage this condition with overall good results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- Pregabalin 75mg and Gabapentin 300mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 25 Apr 2022to 30 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Previous spine surgery and subsequent chronic back pain
Who cannot join
- Patients with connective tissue diseases
- Patients with psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome
Neuropathic pain is a common complication following different types of spine surgery making negative impact on health, along with life style changes and management, many neurologist prescribed either Pregabalin or Gabapentin to manage this condition with overall good results.
our study aims to evaluate the efficacy of Pregabalin and Gabapentin in the management of this condition and to compare between them
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Pregabalin 75mg, Gabapentin 300mg
- Keywords
- Pregabalin, Gabapentin, neuropathic pain, spine surgery
- Medical subject headings
- Failed Back Surgery Syndrome, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mgDrug
Each patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect.
Gabapentin 300mgDrug
Each patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | A dose of 75 mg of Pregabalin twice daily for one month will be prescribed to each patient enrolled this study arm Receives: Drug: Pregabalin 75mg |
| Gabapentin | Active comparator | A dose of 300 mg of Gabapentin twice daily for one month will be prescribed to each patient enrolled this study arm Receives: Drug: Gabapentin 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in Neuropathic pain management
Visual analogue scale pain, minimum score is 0, maximum is 10, the higher ther score the more severe pain
Measured: outcome will be assessed one month after the initiation of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start25 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laith Thamer Al-Ameri, Al-Kindy College of Medicine
- Investigators
- Laith Al-Ameri, Study director, University of Baghdad - Al-Kindy College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324761
- Sponsor's protocol ID
- 13 Al-KindyCM
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2022
- Last updated
- 1 May 2023
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT05324761
- Acronym / sponsor ID
- 13 Al-KindyCM
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- Pregabalin, Gabapentin, neuropathic pain, spine surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Apr 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.
Neuropathic pain is a common complication following different types of spine surgery making negative impact on health, along with life style changes and management, many neurologist prescribed either Pregabalin or Gabapentin to manage this condition with overall good results.
our study aims to evaluate the efficacy of Pregabalin and Gabapentin in the management of this condition and to compare between them
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: Pregabalin 75mgA dose of 75 mg of Pregabalin twice daily for one month will be prescribed to each patient enrolled this study arm |
| Gabapentin | Active comparator | Drug: Gabapentin 300mgA dose of 300 mg of Gabapentin twice daily for one month will be prescribed to each patient enrolled this study arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Previous spine surgery and subsequent chronic back pain
Key exclusion criteria (2 listed)
- Patients with connective tissue diseases
- Patients with psychiatric illnesses
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 |
|---|---|---|
| Pregabalin 75mgEach patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect. | Drug | Pregabalin |
| Gabapentin 300mgEach patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect. | Drug | Gabapentin |
Primary outcome
Efficacy in Neuropathic pain management
Time frame: outcome will be assessed one month after the initiation of medication
Visual analogue scale pain, minimum score is 0, maximum is 10, the higher ther score the more severe pain
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 May 2023.
- Individual participant dataSharing planned: No
Related trials for Failed Back Surgery Syndrome
RecruitingObservational study
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
RecruitingPhase 4
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
Back Pain Lower Back, Neck Pain
Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Recruiting
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Failed Back Surgery Syndrome
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.
Laith Al-Ameri study director
University of Baghdad - Al-Kindy College of Medicine
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 Pregabalin 75mg and Gabapentin 300mg in people with Failed Back Surgery Syndrome, run by Al-Kindy College of Medicine at 1 site in Iraq.
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 2 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 May 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 Iraq. 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?
Efficacy in Neuropathic pain management (time frame: outcome will be assessed one month after the initiation of medication). 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 1 May 2023.