Clinical trial NCT04469088: Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders.
Official title: Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Dry Needling
Musculoskeletal Manipulations
Keywords: Temporomandibular joint disorders
Dry Needling
Manual Therapy
Orofacial disability
Neck Pain
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temporomandibular Joint Disorders (TJD) represent a set of conditions that involve pain and dysfunction of the temporomandibular joint. TJD are a frequent disability affection in the worldwide population and the 35% of affected present at least a symptom such as orofacial pain, mouth movement limitations and snapping or crying temporo-mandibular. Due to the increase of the incidence of the TJD the investigators propose to complete this study.

A randomized controlled trial with parallel groups have been designed and blind evaluation of the response variable.

The hypothesis is that dry needling produces a positive effect in the involved variables of this study in comparison with manual therapy.

The aim of this RCT is to compare the effectiviness of the application of manual therapy in comparison with dry needling in the perceived pain, mouth opening, the degree of cervical disability and the pressure-pain threshold (PPT) of myofascial trigger points (MTrP) in patiens with TJD.


Eligibility criteria: Inclusion Criteria:

Female and male subjects with an age of 18-65 years old with a TJD who meet at least two of the following inclusion criteria:

* Pain on palpation of the myofascial trigger points of the masseter, anterior temporal, posterior temporal, external pterygoid and sternocleidomastoid muscles (minimum 3 active trigger points).
* Pain in the temporomandibular joint.
* Limitation of mouth opening.
* Clicking of the temporomandibular joint.

Exclusion Criteria:

Subjects who present any of the following characteristics:

* fibromyalgia, orthodontia, systemic disease, syndrome or pathology with possible joint repercussions, patients undergoing treatment with NSAIDs, jaw fracture, mandibular surgery, non-collaborative patients or patients with phobia needles.

Primary outcomes:
measure: Pain intensity
timeFrame: At the beginning of treatment, the first day
measure: Change from Baseline Pain intensity
timeFrame: At the ended of the first session, after an hour.
measure: Change from Baseline Pain intensity
timeFrame: At the end of treatment, an average of 2 weeks.
measure: Pain after trigger points pressure
timeFrame: At the beginning of treatment, the first day
measure: Change from Baseline Pain after trigger points pressure
timeFrame: At the ended of the first session, after an hour.
measure: Change from Baseline Pain after trigger points pressure
timeFrame: At the end of treatment, an average of 2 weeks
measure: Open mouth movements
timeFrame: At the beginning of treatment, the first day
measure: Change from Baseline open mouth movements
timeFrame: At the ended of the first session, after an hour.
measure: Change from Baseline open mouth movements
timeFrame: At the end of the tratment, an average of 2 weeks
measure: Neck Disability Index
timeFrame: At the beginning of treatment, the first day.
measure: Change from Baseline Neck Disability Index
timeFrame: At the end of the treatment, an average of 2 weeks
Secondary outcomes:
Other outcomes:
measure: Demographic variables
timeFrame: At the beginning of the treatment, the first day.
Locations:
city: Córdoba
country: Spain
facility: Clínica de Fisioterapia y Rehabilitación Miophys S.C.A.
Study officials:
affiliation: University of Jaén
name: María Catalina Osuna Pérez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pessoa DR, Costa DR, Prianti BM, Costa DR, Delpasso CA, Arisawa EALS, Nicolau RA. Association of facial massage, dry needling, and laser therapy in Temporomandibular Disorder: case report. Codas. 2018 Nov 29;30(6):e20170265. doi: 10.1590/2317-1782/20182017265.
citation: Blasco-Bonora PM, Martin-Pintado-Zugasti A. Effects of myofascial trigger point dry needling in patients with sleep bruxism and temporomandibular disorders: a prospective case series. Acupunct Med. 2017 Mar;35(1):69-74. doi: 10.1136/acupmed-2016-011102. Epub 2016 Oct 3.
citation: Gonzalez-Perez LM, Infante-Cossio P, Granados-Nunez M, Urresti-Lopez FJ, Lopez-Martos R, Ruiz-Canela-Mendez P. Deep dry needling of trigger points located in the lateral pterygoid muscle: Efficacy and safety of treatment for management of myofascial pain and temporomandibular dysfunction. Med Oral Patol Oral Cir Bucal. 2015 May 1;20(3):e326-33. doi: 10.4317/medoral.20384.