Comparative Efficacy of PRP and Dry Needling in Management of Trigger Points in Masseter Muscle in MPS Patients

NCT04286880 | Unknown Phase 3

• 1 other identifier: varsha10av
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Comparative Efficacy of Platelet Rich Plasma injection and Dry Needling in management of trigger points in masseter muscle in Myofascial Pain Syndrome patients. Rationale: Pain and trismus caused by Myofascial pain syndrome in masticatory muscles are one of the prime concerns for the patients. In the recent times, Platelet Rich Plasma therapy has been studied extensively and has produced promising results. It is used to promote sarcomere repair by concentrating growth factors and decrease inflammation by inhibiting pro-inflammatory and apoptotic cells. Thus, the present study is designed to evaluate the efficacy of Platelet Rich Plasma injection in trigger points in masseter muscle in myofascial pain syndrome patients. Research Question P: Population (Patients with trigger points in masseter muscle) I: Intervention (PRP injection) C: Control (Dry needling) O: Outcome (Improvement in symptom of pain ) T: Time Frame (1 year) S: Study Design (Randomized clinical trial) Setting in Haryana , India Is Platelet Rich Plasma more effective as compared to dry needling alone in treatment of trigger points in masseter muscle in Myofascial Pain Syndrome patients ?

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• assessment of pain improvement upto 3 months

  using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain

  3 months

• Maximal Mouth Opening change from baseline to 3 months

  measured by digital vernier callipers

  3 months

Secondary Outcomes (5)

• Range of Right and left Lateral excursion movements

  3 months

• Range of Protrusive movement

  3 months

• Need for pain medicine utilization

  3 months

• assessment of Patient satisfaction

  3 months

• assessment of Sleep pattern

  3 months.

Study Arms (2)

TEST GROUP

EXPERIMENTAL

Test group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle.

Procedure: PRP injection

CONTROL GROUP

ACTIVE COMPARATOR

In control group, dry needling will be performed.

Procedure: Dry needling

Interventions

PRP injection PROCEDURE

Clinically proven cases of Trigger points in masseter muscle will be randomly and equally divided into test group and control group. The selected subjects will be divided into two groups. Test group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle according to symptoms of patient at baseline (0 week). PRP will be prepared as per methodology mentioned by Okuda et al 2003.

TEST GROUP

Dry needling PROCEDURE

In control group all the armamentarium and procedure will remain same except that no PRP solution will be delivered. Only dry needling will be performed on the baseline.

CONTROL GROUP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The following patients will be included in the study:
• Patients diagnosed with myofascial pain within masseter muscle as per RDC/TMD (Ia and Ib)
• Patient's consent for participation in this study.

You may not qualify if:

• Patients with phobia to needles
• Patients who have undergone previous treatment for myofascial pain in past 3 months
• Patients with active infection at the site of injection
• Patients with history of head and neck fracture in the past 6 months.
• Patients with healing disorder or systemic disease where healing response is compromised
• Patients on anticoagulant medication
• Patients with bleeding and clotting disorder
• Patients with epilepsy/seizures
• Pregnancy/ Lactation
• Patients addicted to alcohol/ drug

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Sanjay Tewari

CONTACT

01262283876; principalpgidsrohtak@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 27, 2020
• Study Start: February 24, 2020
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

IN (1)