Clinical trial NCT06708377: Dry Needling and Myofascial Massage Therapy on Patient With Temporomandibular Joint Dysfunction
Official title: Comparison of Effects Of Dry Needling And Myofascial Massage Therapy On Masseter Muscle In Patients With Temporomandibular Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Dysfunction
Keywords: TMJ Dysfunction
Dry needling
Myofascial massage therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of effects of dry needling and myofascial massage therapy on masseter muscle in patients with temporomandibular joint dysfunction. A randomized control trial was conducted at DSK Physio \& Rehab Centre, Ulfat Dental Associates and The Physiotherapy Clinic, Islamabad. The sample size was 24 calculated through G-power 3.1. The participants were divided into two interventional groups each having 12 participants. The study duration was six months. Sampling technique applied was convenience sampling for recruitment and group randomization using flip coin method. Only 25 to 45 years participants with having TMJ Dysfunction and reduced mouth opening were included in the study. Tools used in this study are NPRS, Maximal Mouth Opening and Fonseca Anamnestic Index. Data was collected at baseline, at the end of 1st week and 3rd week. Data analyzed through SPSS version26.

Detailed description: Temporomandibular joint (TMJ) dysfunction encompasses a range of conditions affecting the jaw joint and surrounding muscles, often resulting in pain, restricted movement, and functional impairment. Temporomandibular disorder (TMD) can be categorized as intra-articular, affecting structures within the temporomandibular joint (TMJ), or extra-articular, involving surrounding muscles and structures. Intra-articular TMD includes conditions like disc displacement, osteoarthritis, or subluxation, while extra-articular TMD manifests as muscle pain or dysfunction, such as myofascial pain syndrome.

Reduced mouth opening or limited mandibular range of motion, is a condition characterized by restricted movement of the TMJ resulting in diminished ability to open the mouth. It can arise from various etiologies including trauma, inflammation, muscle dysfunction, or surgical interventions affecting the masticatory muscles or TMJ. Trismus may manifest acutely or chronically and can significantly impair oral functions such as eating, speaking, and oral hygiene maintenance. Assessment typically involves measurement of maximal inter-incisal opening (MIO) using standardized methods, with normal values varying depending on age, gender, and population.

The Maximal Mouth Opening (MMO) generalized reference range is from 42 to 60 mm.

Patients diagnosed with myofascial temporomandibular disorder (TMD) commonly present myofascial trigger points (MTrPs) located in both the neck and masticatory muscles. These trigger points are believed to be integral to the development and expression of myofascial TMD symptoms. MTrPs represent hypersensitive sites within taut bands of skeletal muscle or muscle fascia. Their activation can lead to a range of sensory, motor, neurological, and autonomic symptoms, contributing significantly to the clinical presentation of myofascial TMD. Among the various treatment modalities, myofascial massage therapy and dry needling have gained attention for their potential efficacy in managing TMJ dysfunction, particularly in addressing the associated muscular component.

Myofascial massage therapy targets the fascia, the connective tissue surrounding muscles, aiming to release tension, improve blood flow, and restore mobility. Massage therapy can help break down trigger points through several mechanisms. Firstly, it increases blood flow to the affected area, which helps deliver oxygen and nutrients while removing waste products, aiding in tissue repair. It can also disrupt the tight muscle fibers and release tension, allowing the muscle to relax and the trigger point to dissipate. Additionally, massage stimulates the nervous system, promoting the release of endorphins and other natural pain-relieving chemicals, which can help alleviate discomfort associated with trigger points. Lastly, the pressure and manipulation applied during massage can physically break down adhesions and knots within the muscle tissue, helping to release the trigger point.In the context of TMJ dysfunction, myofascial massage may involve techniques such as effleurage, petrissage, and trigger point therapy to alleviate muscle tightness, reduce pain, and enhance jaw function.

This approach focuses on manual manipulation of soft tissues to promote relaxation and alleviate muscular imbalances contributing to TMJ symptoms. Dry needling involves the insertion of thin needles into trigger points or areas of muscular tension to elicit a therapeutic response. Unlike acupuncture, which follows traditional Chinese medicine principles, dry needling targets specific muscular trigger points rather than meridian pathways.

In the context of TMJ dysfunction, dry needling aims to deactivate hyperirritable trigger points, reduce muscle tension, and alleviate pain by promoting local blood flow and releasing endogenous opioids. The recent systematic review emphasized the necessity for conducting larger trials with a decreased risk of bias to thoroughly evaluate the impact of dry needling on myofascial temporomandibular disorder (TMD). This recommendation stems from the observation of both the low quality of evidence and the heightened risk of bias evident in certain studies included in the review.

While both myofascial massage therapy and dry needling target muscular dysfunction associated with TMJ disorders, they differ in their mechanisms of action and application. Myofascial massage therapy relies on manual manipulation techniques to directly address muscle tension and fascial restrictions, promoting relaxation and improved tissue mobility. In contrast, dry needling involves the precise insertion of needles into trigger points to stimulate neuromuscular responses and induce therapeutic effects, such as pain relief and muscle relaxation. Dry needling is a common intervention in clinical practice nowadays, but its effectiveness compared to other conservative treatment modalities, such as manual therapy, remains unclear.

In a 2022 network meta-analysis (NMA), which evaluated the effectiveness of twelve different treatment modalities for patients with myofascial temporomandibular disorder (TMD), manual therapy emerged as the most effective treatment option. Nevertheless, the authors advised a careful interpretation of the findings, citing study limitations and a paucity of robust evidence.

According to a systematic review published in 2023, it was concluded that no significant differences in terms of pain reduction was observed between dry needling and manual therapy in patients with myofascial TMD. High variability was observed in available literature for methods of application of these interventions.

Despite growing interest in myofascial massage therapy and dry needling for TMJ dysfunction, there remains a gap in the literature regarding direct comparisons of their efficacy, safety, and long-term outcomes. While individual studies have investigated the effects of each modality separately, few studies have directly compared their effectiveness in improving TMJ symptoms and functional outcomes. Additionally, factors such as treatment protocols, patient characteristics, and practitioner expertise may influence treatment outcomes and complicate direct comparisons between myofascial massage therapy and dry needling.

This lack of comparative randomized clinical trials between dry needling and myofascial massage therapy limits determine which technique of the two is better. So, the available literature has only made indirect comparisons and therefore, the current study aims to find the comparative effectiveness of myofascial massage therapy and dry needling for TMJ dysfunction. The findings will help inform evidence-based management strategies for TMJ dysfunction.

Eligibility criteria: Inclusion Criteria:

* Participants with TMJ dysfunction
* A mouth opening of less than 39 mm for males and 36mm for females
* Patients with Trigger points in tout band of masseter
* Mild to moderate pain on NPRS
* 45-75 points on Fonseca's questionnaire

Exclusion Criteria:

* Bell's palsy
* Trigeminal neuralgia
* Wearing any form of dental prosthesis
* Any form of surgery in or around the TMJ
* History of trauma or fracture in and around the TMJ
* Not consenting to take part in the study

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 5 mints at every session
measure: Maximum Mouth Opening (MMO)
timeFrame: 10 mint at every session
Secondary outcomes:
measure: Fonseca Anamnestic Index (FAI)
timeFrame: 15 mints
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Lal Gul Khan, MScPT
role: PRINCIPAL_INVESTIGATOR
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