Spinal Disk InjuryPhase 2NCT07370233

Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy

A Phase 2 study testing Epidural Injection, thermal Radiofrequency Ablation and Spinal Fixation in people with Spinal Disk Injury, run by Benha University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 23 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Spinal Disk Injury
What is being tested?: Epidural Injection, thermal Radiofrequency Ablation and Spinal Fixation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteEgypt
Study dates: 20 Feb 2023to 23 Sep 2025
Phase: Phase 2
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 23 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients with persistent back pain after microdiscectomy (FBSS).
Failure of conservative treatment for at least six months.
Positive results on a diagnostic lumbar facet nerve block.

Who cannot join

Spinal instability, fractures, or spondylolisthesis.
Severe psychiatric disorders.
Baseline ODI score higher than 60%.
Opioid users or history of adverse reactions to steroids.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Medicine, Benha University
Banhā, Qalyubia Governorate, 13511

Other trials in Egypt

About this study

Official title: Synchronous Percutaneous Facet Radiofrequency and Spinal Fixation With Epidural Injection Therapy as a Management for Persistent Radicular Pain After Microdiscectomy

This interventional study evaluates a "triple therapy" approach-combining percutaneous spinal fixation, facet radiofrequency ablation, and epidural steroid/hyaluronidase injection-for patients with Failed Back Surgery Syndrome (FBSS). The study compares this combined strategy against spinal fixation alone to determine its effectiveness in reducing chronic radicular pain and disability.

Conditions: Spinal Disk Injury
Being tested: Epidural Injection, thermal Radiofrequency Ablation, Spinal Fixation, ELISA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epidural InjectionDrug
Advanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions
thermal Radiofrequency AblationProcedure or surgery
Thermal denervation of the medial branch of the facet nerve at 80°C for 120 seconds using an 18-gauge insulated RF needle.
Spinal FixationProcedure or surgery
Percutaneous insertion of polyaxial screws and pre-contoured rods via the Sextant System to stabilize the affected spinal levels.
ELISADiagnostic test
Collection of blood samples (S1 at booking and S2 at 6 months) for ELISA estimation of serum biomarkers including TNF-α, IL-1β, and IL-6.

Study groups in NCT07370233
Study group	Role	What they receive
Triple Therapy Group	Active comparator	Patients with failed back surgery syndrome who receive a combined intervention consisting of thermal radiofrequency ablation of the medial branch, percutaneous spinal fixation (Sextant system), and an epidural injection of triamcinolone mixed with hyaluronidase. Receives: Drug: Epidural Injection; Procedure: thermal Radiofrequency Ablation; Procedure: Spinal Fixation; Diagnostic Test: ELISA
Spinal Fixation Only	Active comparator	Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae. Receives: Procedure: Spinal Fixation; Diagnostic Test: ELISA
Healthy Control	Active comparator	A cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine levels. Receives: Diagnostic Test: ELISA

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Intensity (NRS)
Assessment of back and radicular pain using the 10-point Numeric Rating Scale (NRS)(Score on a scale of 0 to 10)
Measured: 6 months post-intervention
Change in Disability Level (ODI)
Measurement of functional disability using the Oswestry Disability Index (ODI).
Measured: 6 months post-intervention

Secondary outcomes (1)

Serum Concentration of Pro-inflammatory Cytokines (TNF-α)
Evaluation of the anti-inflammatory mechanism by measuring serum Tumor Necrosis Factor-alpha levels via ELISA.
Measured: 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 202323 Sep 2025

First posted27 Jan 2026
Study start20 Feb 2023
Primary completion22 Mar 2025
Study completion23 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spinal Disk InjuryStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07370233
Sponsor's protocol ID: Rc 8-1-2023
Status last verified: Jan 2026
First submitted: 19 Jan 2026
Last updated: 27 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Synchronous Percutaneous Facet Radiofrequency and Spinal Fixation With Epidural Injection Therapy as a Management for Persistent Radicular Pain After Microdiscectomy
ClinicalTrials.gov ID: NCT07370233
Acronym / sponsor ID: Rc 8-1-2023
Conditions: Spinal Disk Injury
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Benha UniversityUniversity, hospital or other
Study start: 20 Feb 2023 (actual)
Primary completion: 22 Mar 2025 (actual)
Study completion: 23 Sep 2025 (actual)
First posted: 27 Jan 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Triple Therapy Group	Active comparator	Drug: Epidural Injection, Procedure: thermal Radiofrequency Ablation, Procedure: Spinal Fixation, Diagnostic Test: ELISAPatients with failed back surgery syndrome who receive a combined intervention consisting of thermal radiofrequency ablation of the medial branch, percutaneous spinal fixation (Sextant system), and an epidural injection of triamcinolone mixed with hyaluronidase.
Spinal Fixation Only	Active comparator	Procedure: Spinal Fixation, Diagnostic Test: ELISAPatients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae.
Healthy Control	Active comparator	Diagnostic Test: ELISAA cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine levels.

Who may qualify

Ages: 23 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with persistent back pain after microdiscectomy (FBSS).
Failure of conservative treatment for at least six months.
Positive results on a diagnostic lumbar facet nerve block.

Key exclusion criteria (4 listed)

Spinal instability, fractures, or spondylolisthesis.
Severe psychiatric disorders.
Baseline ODI score higher than 60%.
Opioid users or history of adverse reactions to steroids.

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
Epidural InjectionAdvanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions	Drug	Triple Therapy Group
thermal Radiofrequency AblationThermal denervation of the medial branch of the facet nerve at 80°C for 120 seconds using an 18-gauge insulated RF needle.	Procedure or surgery	Triple Therapy Group
Spinal FixationPercutaneous insertion of polyaxial screws and pre-contoured rods via the Sextant System to stabilize the affected spinal levels.	Procedure or surgery	Spinal Fixation Only, Triple Therapy Group
ELISACollection of blood samples (S1 at booking and S2 at 6 months) for ELISA estimation of serum biomarkers including TNF-α, IL-1β, and IL-6.	Diagnostic test	Healthy Control, Spinal Fixation Only, Triple Therapy Group

Primary outcome

Change in Pain Intensity (NRS)
Time frame: 6 months post-intervention
Assessment of back and radicular pain using the 10-point Numeric Rating Scale (NRS)(Score on a scale of 0 to 10)
Change in Disability Level (ODI)
Time frame: 6 months post-intervention
Measurement of functional disability using the Oswestry Disability Index (ODI).

1 secondary outcome

Serum Concentration of Pro-inflammatory Cytokines (TNF-α)
Time frame: 6 months post-intervention

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 27 Jan 2026.

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.

Mohamed Shible, MD principal investigator

Lecturer at Department of Orthopedic Surgery, Faculty of Medicine

Adel Samy Elhammady, MD principal investigator

Lecturer at Department of Orthopedic Surgery, Faculty 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 2 study testing Epidural Injection, thermal Radiofrequency Ablation and Spinal Fixation in people with Spinal Disk Injury, run by Benha University at 1 site in Egypt.

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 4 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 27 Jan 2026. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in Pain Intensity (NRS) (time frame: 6 months post-intervention). The study lists 2 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 NCT07370233.

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 27 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.