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 .

Phase 2

Not yet recruiting

• Conditions: TMJ Disc Disorder
• Interventions: Drug: injection of dextrose 10% in retrodiscal tissues; Drug: injection of dextrose 25% in retrodiscal tissues

• Registration Number: NCT06859034
• Lead Sponsor: Cairo University

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).

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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 Timeline

• Study First Submitted: 2025-02-22
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-02
• Last Update Submitted: 2025-03-02
• Study Start: 2025-03-03
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-09-03
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
injection of dextrose 10% in retrodiscal tissues	injection of dextrose 10% in retrodiscal tissues	GROUP 1 will recieve 10% dextrose
injection of dextrose 25% in retrodiscal tissues	injection of dextrose 25% in retrodiscal tissues	group 2 will recieve 25% dextrose

Primary Outcome Measures

Name	Time	Method
Change in Pain Severity Measured by Numerical Rating Scale (NRS)	Measured at baseline, 1 month, 3 months, and 6 months after injections.	Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be calculated and analyzed . Data Aggregation: Mean change in NRS score with standard deviation (SD)

Secondary Outcome Measures

Name	Time	Method
Change in Maximal Interincisal Opening (MIO) Measured in Millimeters	Measured at baseline, 1 month, 3 months, and 6 months after injections	Maximal interincisal opening (MIO) will be measured using a digital caliper, with values recorded in millimeters (mm). The mean change in MIO from baseline will be reported . Data Aggregation: Mean change in MIO (mm) with standard deviation (SD).
Presence or Absence of Joint Clicking (Binary Outcome)	Measured at baseline, 1 month, 3 months, and 6 months after injections	Joint clicking will be assessed as a binary outcome (Yes/No) based on clinical examination and patient-reported symptoms. The percentage of participants with joint clicking at each time point will be reported.; Data Aggregation: Percentage of participants with joint clicking at each time point