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

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ClinicalTrials.gov Identifier: NCT04286880
Recruitment Status : Recruiting
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

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 ?


Condition or disease Intervention/treatment Phase
Myofascial Pain Syndrome Procedure: PRP injection Procedure: Dry needling Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: TEST GROUP
Test group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle.
Procedure: PRP injection

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.


Active Comparator: CONTROL GROUP
In control group, dry needling will be performed.
Procedure: Dry needling
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 Measures :
  1. assessment of pain improvement upto 3 months [ Time Frame: 3 months ]
    using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain

  2. Maximal Mouth Opening change from baseline to 3 months [ Time Frame: 3 months ]
    measured by digital vernier callipers


Secondary Outcome Measures :
  1. Range of Right and left Lateral excursion movements [ Time Frame: 3 months ]
    measured in mm

  2. Range of Protrusive movement [ Time Frame: 3 months ]
    measured in mm

  3. Need for pain medicine utilization [ Time Frame: 3 months ]
    No. of tablets consumed per week

  4. assessment of Patient satisfaction [ Time Frame: 3 months ]
    by Likert scale

  5. assessment of Sleep pattern [ Time Frame: 3 months. ]
    Visual Analog Scale score (0-10); higher score indicates sleep disturbance



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286880


Contacts
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Contact: Sanjay Tewari 01262283876 principalpgidsrohtak@gmail.com

Locations
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India
PGIDS Recruiting
Rohtak, Haryana, India, 124001
Contact: Sanjay Tewari    01262283876    principalpgids@yahoo.in   
Contact: Ambika Gupta         
Sponsors and Collaborators
Postgraduate Institute of Dental Sciences Rohtak
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Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT04286880    
Other Study ID Numbers: varsha10av
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases