Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-25 @ 2:50 PM
Study NCT ID:
NCT05914350
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison between ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis; a Randomized Double Blinded Controlled Study
Detailed Description:
The sacroiliac joints (SIJ) are the largest axial joints in the human body. By aging, osteoarthritic degeneration occurs to SIJ. SIJ dysfunction typically results from abnormal motion and malalignment of the joint (1).
SIJ pain is one of the differential diagnoses of low back pain. Approximately, 10-25% of these patients will have SIJ dysfunction which should be considered clinically (1, 2). This pain affects physical, psychological and social aspects of the person reducing the work performance. It imposes a huge burden on nations globally (3, 4).
SIJ pain can be a difficult condition to treat and a multidisciplinary approach to treatment including multimodal medical, psychological, physical, and interventional approach is recommended (5).
Corticosteroids are a very magic therapy since their first use and they offer anti-inflammatory mechanisms to reduce low back pain and joint pain. SIJ steroid injections are typically performed for SIJ pain related to osteoarthritis, ligamentous sprain and sacroiliitis associated with inflammatory spondyloarthropathies (5, 6).
Intra-articular steroid injections have intermediate-term benefits, in which more than half of the patients had positive responses to treatment in a 6-month follow-up (7, 8).
Another treatment modality is Platelet-rich plasma (PRP) which is autologous blood that contains platelet concentrations above normal physiological levels (9). PRP is believed to stimulate regeneration through the release of growth factors and proteins that may be involved in repairing the degeneration (10, 11).
While corticostroid injection has rapid onset of pain releif with short duration, the PRP injection has delayed onset and long term of pain releif in recent studies (12-14).
Ozone therapy has been used in the treatment of many musculoskeletal diseases including low back pain (LBP), lumbar disk herniation, cervical pain, cervical disk herniation, failed back surgery syndrome, degenerative spinal disease, knee osteoarthritis, meniscal injuries, sacroiliitis, plantar fasciitis and carpal tunnel syndrome (8, 15). However, ozone therapy is not tested well in SIJ. Ozone has multiple mechanisms of action:, antioxidant, analgesic and antiinflammatory effects (16, 17).
Ultrasound has gained increasing popularity in pain management (18). Furthermore, it is a valuable tool for pain physicians in confirming the diagnosis of many musculoskeletal pain conditions (19). It has many advantages when compared to fluoroscopy techniques (20). It has no radiation exposure, procedures can be done outside operating room which will decrease the costs (21).
SIJ pain is one of the differential diagnoses of low back pain. Approximately, 10-25% of these patients will have SIJ dysfunction which should be considered clinically (1, 2). This pain affects physical, psychological and social aspects of the person reducing the work performance. It imposes a huge burden on nations globally (3, 4).
SIJ pain can be a difficult condition to treat and a multidisciplinary approach to treatment including multimodal medical, psychological, physical, and interventional approach is recommended (5).
Corticosteroids are a very magic therapy since their first use and they offer anti-inflammatory mechanisms to reduce low back pain and joint pain. SIJ steroid injections are typically performed for SIJ pain related to osteoarthritis, ligamentous sprain and sacroiliitis associated with inflammatory spondyloarthropathies (5, 6).
Intra-articular steroid injections have intermediate-term benefits, in which more than half of the patients had positive responses to treatment in a 6-month follow-up (7, 8).
Another treatment modality is Platelet-rich plasma (PRP) which is autologous blood that contains platelet concentrations above normal physiological levels (9). PRP is believed to stimulate regeneration through the release of growth factors and proteins that may be involved in repairing the degeneration (10, 11).
While corticostroid injection has rapid onset of pain releif with short duration, the PRP injection has delayed onset and long term of pain releif in recent studies (12-14).
Ozone therapy has been used in the treatment of many musculoskeletal diseases including low back pain (LBP), lumbar disk herniation, cervical pain, cervical disk herniation, failed back surgery syndrome, degenerative spinal disease, knee osteoarthritis, meniscal injuries, sacroiliitis, plantar fasciitis and carpal tunnel syndrome (8, 15). However, ozone therapy is not tested well in SIJ. Ozone has multiple mechanisms of action:, antioxidant, analgesic and antiinflammatory effects (16, 17).
Ultrasound has gained increasing popularity in pain management (18). Furthermore, it is a valuable tool for pain physicians in confirming the diagnosis of many musculoskeletal pain conditions (19). It has many advantages when compared to fluoroscopy techniques (20). It has no radiation exposure, procedures can be done outside operating room which will decrease the costs (21).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: