Lower Back Pain ChronicPhase 2NCT07268885
PRP Spinoplasty for Chronic Low Back Pain With Multiple Pathologies: A Quasi-Experimental Study
A Phase 2 study testing Spinoplasty with Platelet Rich Plasma in people with Lower Back Pain Chronic and Lumbar Disc Disease, run by Allmed Medical Center at 1 site in Palestinian Territories.
Trial summary
This study aimed to evaluate the efficacy and safety of a comprehensive, multi-target injection protocol, termed 'PRP Spinoplasty,' for managing chronic LBP stemming from concurrent lumbar disc and facet joint disease with associated muscle spasms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Back Pain Chronic, Lumbar Disc Disease, Facet Joint Arthritis
- What is being tested?
- Spinoplasty with Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 15 Sep 2024to 1 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of both sexes; ages between 18 and 80 years.
- Lower back pain consistent with lumbosacral radiculopathy, facet arthropathy, and muscle spasms.
- MRI-confirmed lumbar spine pathology (disc disease and/or facet arthropathy).
- Failure to respond to at least 3 months of conservative therapy (NSAIDS and physical therapy).
- Pain score ≥ 6; on the 10-point Numeric Pain Scale (NPS) at baseline.
Who cannot join
- Presence of local or systemic infection, or fever.
- Diagnosed with cancer within the past 12 months.
- Unable to give a consent.
- History of spinal deformity such as fracture, or severe spinal stenosis causing neurological deficit.
- Presence of lower extremity weakness or urinary tract symptoms related to spinal pathology.
- Previous spinal decompression or fusion surgery at the treatment level.
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- Receipt of any spine injection within the previous 12 months.
- Use of NSAIDs within 2 weeks prior to, or 6 weeks following the procedure.
- Use of corticosteroids within 6 weeks prior, or after the procedure.
- Use of anticoagulation or antiplatelet drugs (excluding low-dose Aspirin).
- History of blood disorders.
- History of any major surgery within the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Platelet Rich Plasma Spinoplasty in the Management of Lower Back Pain Due to Multiple Pathologies: A Quasi-Experimental Study
This study aimed to evaluate the efficacy and safety of a comprehensive, multi-target injection protocol, termed 'PRP Spinoplasty,' for managing chronic LBP stemming from concurrent lumbar disc and facet joint disease with associated muscle spasms.
Read the detailed description
A quasi-experimental study was conducted on 29 patients with chronic LBP who failed conservative therapy. The PRP Spinoplasty protocol involved a single-session, fluoroscopy-guided administration of autologous PRP to the interlaminar epidural space, affected facet joints, and paraspinal muscle trigger points. Outcomes were assessed using the Numeric Pain Scale (NPS), Oswestry Disability Index (ODI), and Single Assessment Numeric Evaluation (SANE) at baseline and at 1 week, 1 month, 3 months, and 6 months post-procedure.
- Being tested
- Spinoplasty with Platelet Rich Plasma
- Keywords
- Platelet Rich Plasma, Lower back pain, lumbar disc disease
- Medical subject headings
- Intervertebral disc disease, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinoplasty with Platelet Rich PlasmaBiological
Also called Epidural injection, Facet Joint Injection, Trigger Point Injection
The patient received a procedure called "Spinoplasty" which interlaminar epidural, facet joints and trigger point injection with Platelet Rich Plasma (PRP).
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with chronic low back pain secondary to lumbar disc disease and facet arthropathy | Experimental | The study population consisted of 35 adult patients with a diagnosis of chronic low back pain secondary to lumbar disc disease and facet arthropathy, with an associated component of muscular spasm. Diagnoses were confirmed by an interventional pain specialist based on a detailed medical history, physical examination, and magnetic resonance imaging (MRI) findings. Receives: Biological: Spinoplasty with Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantifying pain intensity using Numeric Pain Scale (NPS)
An 11-point scale (0 = no pain, 10 = worst imaginable pain) used to quantify pain intensity
Measured: 0-6 months
Assessing level of functional disability using Oswestry Disability Index (ODI)
A 10-item questionnaire assessing the level of functional disability due to low back pain. Scores are calculated from a raw point score of 0-52, with lower scores indicating less disability. The raw score corresponds to the following disability levels: 0-4 points (No disability), 5-14 points (Mild disability), 15-24 points (Moderate disability), 25-34 points (Severe disability), and 35-52 points (Completely disabled)
Measured: 0-6 months
Assessing patient's condition using Single Assessment Numeric Evaluation (SANE)
A patient-reported global assessment score where patients rate their condition on a scale of 0-100%, comparing their current status to their pre-injury baseline
Measured: 0-6 months
Secondary outcomes (1)
Assessing adverse events from treatment
Adverse events were monitored and systematically recorded at each follow-up contact. Patients were asked about any potential complications, including but not limited to severe post-procedural pain, signs of infection (fever, erythema, swelling), new or worsening neurological symptoms, or any other unexpected medical events. we use a checklist of possible complications questionnaire that patients were asked about during follow-ups.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start15 Sep 2024
- Primary completion1 Mar 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back Pain ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allmed Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mustafa A Hammad, Allmed Medical Center
- Investigators
- Mustafa A Hammad, MD, Principal investigator, Allmed Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268885
- Sponsor's protocol ID
- HC.MRC.March4222024
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the reported results (de-identified clinical and demographic variables) will be made available to qualified researchers upon reasonable request. All shared data will be fully anonymized in accordance with institutional and ethical guidelines. No direct identifiers will be included.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Platelet Rich Plasma Spinoplasty in the Management of Lower Back Pain Due to Multiple Pathologies: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07268885
- Acronym / sponsor ID
- HC.MRC.March4222024
- Keywords
- Platelet Rich Plasma, Lower back pain, lumbar disc disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Allmed Medical CenterUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 Dec 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.
This study aimed to evaluate the efficacy and safety of a comprehensive, multi-target injection protocol, termed 'PRP Spinoplasty,' for managing chronic LBP stemming from concurrent lumbar disc and facet joint disease with associated muscle spasms.
Detailed description
A quasi-experimental study was conducted on 29 patients with chronic LBP who failed conservative therapy. The PRP Spinoplasty protocol involved a single-session, fluoroscopy-guided administration of autologous PRP to the interlaminar epidural space, affected facet joints, and paraspinal muscle trigger points. Outcomes were assessed using the Numeric Pain Scale (NPS), Oswestry Disability Index (ODI), and Single Assessment Numeric Evaluation (SANE) at baseline and at 1 week, 1 month, 3 months, and 6 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with chronic low back pain secondary to lumbar disc disease and facet arthropathy | Experimental | Biological: Spinoplasty with Platelet Rich PlasmaThe study population consisted of 35 adult patients with a diagnosis of chronic low back pain secondary to lumbar disc disease and facet arthropathy, with an associated component of muscular spasm. Diagnoses were confirmed by an interventional pain specialist based on a detailed medical history, physical examination, and magnetic resonance imaging (MRI) findings. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals of both sexes; ages between 18 and 80 years.
- Lower back pain consistent with lumbosacral radiculopathy, facet arthropathy, and muscle spasms.
- MRI-confirmed lumbar spine pathology (disc disease and/or facet arthropathy).
- Failure to respond to at least 3 months of conservative therapy (NSAIDS and physical therapy).
- Pain score ≥ 6; on the 10-point Numeric Pain Scale (NPS) at baseline.
Key exclusion criteria (12 listed)
- Presence of local or systemic infection, or fever.
- Diagnosed with cancer within the past 12 months.
- Unable to give a consent.
- History of spinal deformity such as fracture, or severe spinal stenosis causing neurological deficit.
- Presence of lower extremity weakness or urinary tract symptoms related to spinal pathology.
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 |
|---|---|---|
| Spinoplasty with Platelet Rich PlasmaAlso: Epidural injection, Facet Joint Injection, Trigger Point InjectionThe patient received a procedure called "Spinoplasty" which interlaminar epidural, facet joints and trigger point injection with Platelet Rich Plasma (PRP). | Biological | Adult patients with chronic low back pain secondary to lumbar disc disease and facet arthropathy |
Primary outcome
Quantifying pain intensity using Numeric Pain Scale (NPS)
Time frame: 0-6 months
An 11-point scale (0 = no pain, 10 = worst imaginable pain) used to quantify pain intensity
Assessing level of functional disability using Oswestry Disability Index (ODI)
Time frame: 0-6 months
A 10-item questionnaire assessing the level of functional disability due to low back pain. Scores are calculated from a raw point score of 0-52, with lower scores indicating less disability. The raw score corresponds to the following disability levels: 0-4 points (No disability), 5-14 points (Mild disability), 15-24 points (Moderate disability), 25-34 points (Severe disability), and 35-52 points (Completely disabled)
Assessing patient's condition using Single Assessment Numeric Evaluation (SANE)
Time frame: 0-6 months
A patient-reported global assessment score where patients rate their condition on a scale of 0-100%, comparing their current status to their pre-injury baseline
1 secondary outcome
Assessing adverse events from treatment
Time frame: 0-6 months
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 8 Dec 2025.
- Machado ES, Ambach MA, Caldas JM, Wei JJ, Bredemeier M. Personalized multitarget biologic injection in the spine: prospective case series of multitarget platelet-rich plasma for low back pain. Regen Med. 2022;17(1):11-22Link provided by the sponsor.
- Zhang X et al. The Clinical Efficacy of Platelet-Rich Plasma Injection Therapy versus Different Control Groups for Chronic Low Back Pain: A Network Meta-Analysis of Randomized Controlled Trials. J Pain Res. 2024;17:1077-1089Link provided by the sponsor.
- Muthu S, Viswanathan VK, Gangadaran P. Is platelet-rich plasma better than steroids as epidural drug of choice in lumbar disc disease with radiculopathy? Meta-analysis of randomized controlled trials. Exp Biol Med. 2025;Volume 250Link provided by the sponsor.
- Mohammed S, Yu J. Platelet-rich plasma injections: an emerging therapy for chronic discogenic low back pain. J Spine Surg. 2018;4(1):115Link provided by the sponsor.
- Baltzer AW, Enneper J, Baltzer LM, Godde G. Platelet Rich Plasma for the Therapy of the Lumbar Facet Joint Syndrome: A Prospective Study About CT-Guided Facet Joint Injections With PRP Compared to Local Anesthetics. Orthop Rev (Pavia). 2025;17:141416Link provided by the sponsor.
- Xuan Z, Yu W, Dou Y, Wang T. Efficacy of Platelet-rich Plasma for Low Back Pain: A Systematic Review and Meta-analysis. J Neurol Surgery, Part A Cent Eur Neurosurg. 2020;81(6):529-534Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the reported results (de-identified clinical and demographic variables) will be made available to qualified researchers upon reasonable request. All shared data will be fully anonymized in accordance with institutional and ethical guidelines. No direct identifiers will be included.
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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.
Mustafa A Hammad, MD principal investigator
Allmed Medical Center
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 Spinoplasty with Platelet Rich Plasma in people with Lower Back Pain Chronic and Lumbar Disc Disease, run by Allmed Medical Center at 1 site in Palestinian Territories.
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 5 inclusion and 12 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 8 Dec 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 Palestinian Territories. 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?
Quantifying pain intensity using Numeric Pain Scale (NPS) (time frame: 0-6 months). The study lists 3 primary outcomes in all. 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 8 Dec 2025.