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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 .

ConditionTMJ Disc Disorder
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

The clinical or radiographic signs of disc displacement without reduction .

A history of allergic reactions to any components of the injectable solution.

Blood dyscrasias and systemtic diseases .

Previous surgery of the affected joint.

Trial design

Design model

Parallel

Treatments tested in this trial

  • injection of dextrose 10% in retrodiscal tissues

    Drug

    group 1 will recieve 10% dextrose in retrodiscal tissues

  • injection of dextrose 25% in retrodiscal tissues

    Drug

    group 2 will recieve 25% dextrose

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: injection of dextrose 10% in retrodiscal tissuesActive comparator 1 intervention
Group B: injection of dextrose 25% in retrodiscal tissuesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain Severity Measured by Numerical Rating Scale (NRS)

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)

Time frame
Measured at baseline, 1 month, 3 months, and 6 months after injections.

Secondary outcomes

1

Change in Maximal Interincisal Opening (MIO) Measured in Millimeters

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).

Time frame
Measured at baseline, 1 month, 3 months, and 6 months after injections
2

Presence or Absence of Joint Clicking (Binary Outcome)

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

Time frame
Measured at baseline, 1 month, 3 months, and 6 months after injections

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: