Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-29 @ 10:46 AM
Study NCT ID:
NCT06859034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Proliferative Therapy (prolotherapy) on Pain Using Injectable Hypertonic Dextrose 25% Versus Injectable Dextrose 10% in Retrodiscal Tissues in Patients with Anterior Disc Displacement with Reduction: a Randomized Clinical Trial .
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Therapeutic Effect of Proliferative Therapy (prolotherapy) on Pain Using Injectable Hypertonic Dextrose 25% Versus Injectable Dextrose 10% in Retrodiscal Tissues in Patients with Anterior Disc Displacement with Reduction: a Randomized Clinical Trial .
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
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:
prolotherapy is an injection-based treatment method used to alleviate pain, particularly musculoskeletal pain associated with chronic ligament and tendon injuries. The process involves the injection of a solution, typically containing dextrose (a sugar), saline, or other irritants, into the affected tissues. Prolotherapy is believed to stimulate healing by causing a mild inflammatory response that promotes the regeneration of ligaments, tendons, and other connective tissues. This review explores the existing literature on the therapeutic effects of prolotherapy for pain management.
Detailed Description:
Anterior disc displacement with reduction (ADDR) is a common temporomandibular joint (TMJ) disorder, characterized by the displacement of the articular disc in front of the condyle during mouth opening, which then reduces upon closing. This condition often results in pain, restricted jaw movement, and clicking sounds. Conservative treatments, including physical therapy, splint therapy, and pharmacological interventions, are commonly used, but these may not always yield long-term results. Recent studies have explored the role of prolotherapy, particularly the use of dextrose injections, in treating TMJ disorders, including ADDR. Among the variations in prolotherapy, the concentration of dextrose solution-commonly 10% and 25%-is often debated for its potential effectiveness in promoting healing and pain relief. Prolotherapy is often compared to other injection-based treatments, such as corticosteroid injections and platelet-rich plasma (PRP) therapy. A study by Chou et al. (2017) found that prolotherapy was more effective than corticosteroid injections for the management of chronic tendon and ligament pain, with longer-lasting effects and fewer side effects. Similarly, prolotherapy was found to be as effective as PRP for certain conditions, such as chronic tendinopathies, although PRP may offer additional benefits in tissue regeneration due to its higher concentration of growth factors (Gosens et al., 2020).
6
The literature supports prolotherapy as a promising treatment for various chronic pain conditions, especially those involving tendons, ligaments, and joints. Evidence from clinical trials suggests that prolotherapy is effective in reducing pain, improving function, and promoting tissue regeneration in conditions like chronic low back pain, knee osteoarthritis, and soft tissue injuries. However, despite the promising results, the overall quality of evidence remains moderate, and further large-scale, high-quality studies are needed to fully establish its efficacy and long-term outcomes. Prolotherapy is generally safe, but like any invasive treatment, it carries a risk of adverse effects, albeit minimal.
As prolotherapy continues to gain recognition in pain management, its potential as an adjunct or alternative to traditional therapies warrants further investigation.
6
The literature supports prolotherapy as a promising treatment for various chronic pain conditions, especially those involving tendons, ligaments, and joints. Evidence from clinical trials suggests that prolotherapy is effective in reducing pain, improving function, and promoting tissue regeneration in conditions like chronic low back pain, knee osteoarthritis, and soft tissue injuries. However, despite the promising results, the overall quality of evidence remains moderate, and further large-scale, high-quality studies are needed to fully establish its efficacy and long-term outcomes. Prolotherapy is generally safe, but like any invasive treatment, it carries a risk of adverse effects, albeit minimal.
As prolotherapy continues to gain recognition in pain management, its potential as an adjunct or alternative to traditional therapies warrants further investigation.
Study Oversight
Has Oversight DMC:
False
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?: