search
Back to results

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

Primary Purpose

Myofascial Pain Syndrome

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
PRP injection
Dry needling
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA

The following patients will be included in the study:

  1. Patients diagnosed with myofascial pain within masseter muscle as per RDC/TMD (Ia and Ib)
  2. Patient's consent for participation in this study.

EXCLUSION CRITERIA

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

Sites / Locations

  • PGIDSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEST GROUP

CONTROL GROUP

Arm Description

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

In control group, dry needling will be performed.

Outcomes

Primary Outcome Measures

assessment of pain improvement upto 3 months
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Maximal Mouth Opening change from baseline to 3 months
measured by digital vernier callipers

Secondary Outcome Measures

Range of Right and left Lateral excursion movements
measured in mm
Range of Protrusive movement
measured in mm
Need for pain medicine utilization
No. of tablets consumed per week
assessment of Patient satisfaction
by Likert scale
assessment of Sleep pattern
Visual Analog Scale score (0-10); higher score indicates sleep disturbance

Full Information

First Posted
February 18, 2020
Last Updated
February 25, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
search

1. Study Identification

Unique Protocol Identification Number
NCT04286880
Brief Title
Comparative Efficacy of PRP and Dry Needling in Management of Trigger Points in Masseter Muscle in MPS Patients
Official Title
Comparative Efficacy of Platelet Rich Plasma Injection and Dry Needling in Management of Trigger Points in Masseter Muscle in Myofascial Pain Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 ?
Detailed Description
Myofascial pain syndrome (MPS) is a commonly encountered condition frequently associated with the muscles of mastication. It is defined as a regional muscular pain condition characterized by myofascial trigger points found in one or more muscles and/ or connective tissues. A trigger point is an exquisitely tender spot in discrete taut band of hardened muscle that produce local and referred pain, among other symptoms. Associated symptoms may include muscle weakness, muscle spasm, stiffness, decreased range of motion and autonomic dysfunction. Trigger point can be active i.e. always tender or latent i.e. tender only when palpated. Any kind of muscle overuse or direct trauma to the muscle can lead to the development of trigger points. Although muscle damage is not required for the development of trigger point, it may be caused by the disruption of the cell membrane, damage to the sarcoplasmic reticulum with a subsequent release of high amounts of calcium ions, and disruption of cytoskeletal proteins, such as desmin, titin and dystrophin. Muscle overuse leads to ATP depletion which causes oxidative stress resulting in local ischemia and lowered pH with subsequent accumulation of inflammatory mediators at these trigger points. Various therapeutic modalities have been used to treat myofascial trigger points and myofascial pain syndrome including therapeutic ultrasound, muscle stretching, manipulation, acupuncture, occlusal appliances, botulinum injection, pharmacotherapy and dry needling. Platelet rich plasma (PRP) is a newer therapeutic modality for treatment of trigger points. PRP contains many growth factors important for muscle regeneration and myogenesis. The goal of PRP therapy is to concentrate the main growth factors from native blood and to reintroduce them in the injured tissue. Besides healing, it can also decrease pro-inflammatory and apoptotic cells, reducing inflammation. However, still there is paucity of literature and lack of RCT related to use of PRP in trigger points. So, the present study has been designed to evaluate the efficacy of Platelet Rich Plasma injection in trigger points in masseter muscle in myofascial pain syndrome patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEST GROUP
Arm Type
Experimental
Arm Description
Test group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
In control group, dry needling will be performed.
Intervention Type
Procedure
Intervention Name(s)
PRP injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
assessment of pain improvement upto 3 months
Description
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Time Frame
3 months
Title
Maximal Mouth Opening change from baseline to 3 months
Description
measured by digital vernier callipers
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Range of Right and left Lateral excursion movements
Description
measured in mm
Time Frame
3 months
Title
Range of Protrusive movement
Description
measured in mm
Time Frame
3 months
Title
Need for pain medicine utilization
Description
No. of tablets consumed per week
Time Frame
3 months
Title
assessment of Patient satisfaction
Description
by Likert scale
Time Frame
3 months
Title
assessment of Sleep pattern
Description
Visual Analog Scale score (0-10); higher score indicates sleep disturbance
Time Frame
3 months.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjay Tewari
Phone
01262283876
Email
principalpgidsrohtak@gmail.com
Facility Information:
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Tewari
Phone
01262283876
Email
principalpgids@yahoo.in
First Name & Middle Initial & Last Name & Degree
Ambika Gupta

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs