Myofascial Pain SyndromePhase 3NCT04286880
Comparative Efficacy of PRP and Dry Needling in Management of Trigger Points in Masseter Muscle in MPS Patients
A Phase 3 study testing PRP injection and Dry needling in people with Myofascial Pain Syndrome, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- PRP injection and Dry needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 24 Feb 2020to Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Patients with bleeding and clotting disorder
- Patients with epilepsy/seizures
- Pregnancy/ Lactation
- Patients addicted to alcohol/ drug
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Sanjay Tewari, 01262283876, principalpgids@yahoo.in
Ambika Gupta
About this study
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
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.
Read more
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 ?
Read the 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.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- PRP injection, Dry needling
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionProcedure or surgery
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.
Dry needlingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TEST GROUP | Experimental | Test group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle. Receives: Procedure: PRP injection |
| CONTROL GROUP | Active comparator | In control group, dry needling will be performed. Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of pain improvement upto 3 months
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Measured: 3 months
Maximal Mouth Opening change from baseline to 3 months
measured by digital vernier callipers
Measured: 3 months
Secondary outcomes (5)
Range of Right and left Lateral excursion movements
measured in mm
Measured: 3 months
Range of Protrusive movement
measured in mm
Measured: 3 months
Need for pain medicine utilization
No. of tablets consumed per week
Measured: 3 months
assessment of Patient satisfaction
by Likert scale
Measured: 3 months
assessment of Sleep pattern
Visual Analog Scale score (0-10); higher score indicates sleep disturbance
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start24 Feb 2020
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286880
- Sponsor's protocol ID
- varsha10av
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04286880
- Acronym / sponsor ID
- varsha10av
- Conditions
- Myofascial Pain Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST GROUP | Experimental | Procedure: PRP injectionTest group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle. |
| CONTROL GROUP | Active comparator | Procedure: Dry needlingIn control group, dry needling will be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with myofascial pain within masseter muscle as per RDC/TMD (Ia and Ib)
- Patient's consent for participation in this study.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injectionClinically 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. | Procedure or surgery | TEST GROUP |
| Dry needlingIn 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. | Procedure or surgery | CONTROL GROUP |
Primary outcome
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
Maximal Mouth Opening change from baseline to 3 months
Time frame: 3 months
measured by digital vernier callipers
5 secondary outcomes
Range of Right and left Lateral excursion movements
Time frame: 3 months
Range of Protrusive movement
Time frame: 3 months
Need for pain medicine utilization
Time frame: 3 months
assessment of Patient satisfaction
Time frame: 3 months
assessment of Sleep pattern
Time frame: 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRP injection and Dry needling in people with Myofascial Pain Syndrome, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Tewari (01262283876, principalpgidsrohtak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of pain improvement upto 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.