Comparative Efficacy of Prolotherapy and Dry Needling in Management of ADD

NCT04319406 | Unknown Phase 4

• 1 other identifier: Jatin13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pain and trismus caused by Anterior disc displacement ADD of temporomandibular joint (TMJ) are one of the prime concerns for the patients. In the recent times, Inflammatory Prolotherapy has been studied extensively and has produced promising results. In Inflammatory prolotherapy low grade inflammation is induced physiologically by injection of an irritant solution that initiates healing cascade which leads to repair of the joint structures. Thus, the Present study is designed to evaluate the efficacy of dextrose prolotherapy for the treatment of ADD in TMJ.

Conditions

Anterior Disk Displacement TMJ

Outcome Measures

Primary Outcomes (2)

• Intensity of pain

  VAS Score

  6 months

• Maximal mouth opening

  Manual measurement in mm

  6 months

Secondary Outcomes (6)

• Range of Right and left Lateral excursion movements

  6 months

• Range of Protrusive movement

  6 months

• Joint sounds

  6 months

• Pain medicine utilization

  6 months

• Patient satisfaction

  6 months

Study Arms (2)

PROLOTHERAPY

EXPERIMENTAL

Prolotherapy will be performed with 12.5 % Dextrose into superior joint space of involved TMJ

Procedure: Prolotherapy

DRY NEEDLING

ACTIVE COMPARATOR

Dry needling will be performed into superior joint space of involved TMJ

Procedure: Dry needling

Interventions

Prolotherapy PROCEDURE

Test group will be administered 12.5% Dextrose mainly into superior joint space according to symptoms of patient at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required.

PROLOTHERAPY

Dry needling PROCEDURE

Only dry needling will be performed at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required.

DRY NEEDLING

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
• Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.

You may not qualify if:

• Patients with phobia to needles
• Patients who have undergone previous treatment for anterior disc displacement in past 6 months
• Patients who are allergic to the components of prolotherapy solution
• Patients with active infection at the site of injection
• Patients on anticoagulant medication
• Patients with healing disorder or systemic disease where healing response is compromised
• Patients with epilepsy/seizures
• Patients with bleeding and clotting disorder
• Patients with malignancy
• Patients with uncontrolled para-functional habits

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Interventions

Prolotherapy; Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Sanjay Tewari, MDS

CONTACT

01262283876; principalpgidsrohtak@gmail.com

AMBIKA GUPTA, MDS

CONTACT

01262283876; drambika79@rediffmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 24, 2020
• Study Start: January 5, 2020
• Primary Completion: August 5, 2020
• Study Completion: September 5, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

IN (1)