Facet Joint Arthritis, Lower Back Pain Chronic, Lumbar Disc Disease
Conditions
Keywords
Platelet Rich Plasma, Lower back pain, lumbar disc disease
Brief 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.
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.
Interventions
BIOLOGICALSpinoplasty with Platelet Rich Plasma
The patient received a procedure called Spinoplasty which interlaminar epidural, facet joints and trigger point injection with Platelet Rich Plasma (PRP).
Sponsors
Allmed Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantifying pain intensity using Numeric Pain Scale (NPS) | 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) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing adverse events from treatment | 0-6 months | 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. |
Countries
Palestinian Territories
Outcome results
None listed