Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders.

NCT04469088 | Completed DMC

• 1 other identifier: JUN.20/4.PRY
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders; Dry Needling; Musculoskeletal Manipulations

Keywords

Temporomandibular joint disorders; Dry Needling; Manual Therapy; Orofacial disability; Neck Pain

Outcome Measures

Primary Outcomes (11)

• Pain intensity

  Pain Numeric Rating Scale to assess the intensity of the temporomandibular pain level in patients with TJD. Patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"),

  At the beginning of treatment, the first day

• Change from Baseline Pain intensity

  Pain Numeric Rating Scale to assess the intensity of the temporomandibular pain level in patients with TJD. Patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"),

  At the ended of the first session, after an hour.

• Change from Baseline Pain intensity

  Pain Numeric Rating Scale to assess the intensity of the temporomandibular pain level in patients with TJD. Patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"),

  At the end of treatment, an average of 2 weeks.

• Pain after trigger points pressure

  It will be measured by pressure algometry with the Wagner Force Ten model FDX algometer. Thus, a numerical value will be provided for the subjective perception of pain. The unit of measurement used is Kg / cm2. Once the trigger point is located within the taut band, pressure will be exerted perpendicular to the muscle plane and on the PGM through the support surface of the device. We increase the pressure at a constant rate of 1 kg / cm2 / s. When the pressure becomes a painful stimulus, the individual must raise his hand to warn us.

  At the beginning of treatment, the first day

• Change from Baseline Pain after trigger points pressure

  It will be measured by pressure algometry with the Wagner Force Ten model FDX algometer. Thus, a numerical value will be provided for the subjective perception of pain. The unit of measurement used is Kg / cm2. Once the trigger point is located within the taut band, pressure will be exerted perpendicular to the muscle plane and on the PGM through the support surface of the device. We increase the pressure at a constant rate of 1 kg / cm2 / s. When the pressure becomes a painful stimulus, the individual must raise his hand to warn us.

  At the ended of the first session, after an hour.

• Change from Baseline Pain after trigger points pressure

  It will be measured by pressure algometry with the Wagner Force Ten model FDX algometer. Thus, a numerical value will be provided for the subjective perception of pain. The unit of measurement used is Kg / cm2. Once the trigger point is located within the taut band, pressure will be exerted perpendicular to the muscle plane and on the PGM through the support surface of the device. We increase the pressure at a constant rate of 1 kg / cm2 / s. When the pressure becomes a painful stimulus, the individual must raise his hand to warn us.

  At the end of treatment, an average of 2 weeks

• Open mouth movements

  It will be measured with a validated ruler in centimeters.

  At the beginning of treatment, the first day

• Change from Baseline open mouth movements

  It will be measured with a validated ruler in centimeters.

  At the ended of the first session, after an hour.

• Change from Baseline open mouth movements

  It will be measured with a validated ruler in centimeters.

  At the end of the tratment, an average of 2 weeks

• Neck Disability Index

  It will measured with the Spanish version of the Neck Disability Index. The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Higher scores mean a worse outcome.

  At the beginning of treatment, the first day.

• Change from Baseline Neck Disability Index

  It will measured with the Spanish version of the Neck Disability Index. The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Higher scores mean a worse outcome.

  At the end of the treatment, an average of 2 weeks

Other Outcomes (1)

• Demographic variables

  At the beginning of the treatment, the first day.

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

Other: Dry needling

Manual Therapy Treatment

ACTIVE COMPARATOR

Other: Manual Therapy Treatment

Interventions

Dry needling OTHER

Twenty-three patients with TJD will be allocated in Dry Needling Group. They will receive 3 sessions of dry needling separated for 4 days. This treatment will consist of puncturing the active myofascial trigger points (PGM) of the aforementioned muscles. Sterile acupuncture needles of 0.26 mm in diameter by 40 mm in length, guided with a plastic cannula of the Ener-qi brand, will be used. The area will be cleaned with alcohol and a deep puncture of the PGM will be performed, triggering local spasm responses. Needle through the muscle following the technique described by Hong (Hong et al. 1994). After the procedure, the area is compressed with cotton for 90 seconds.

Dry Needling Group

Manual Therapy Treatment OTHER

Twenty-three patients will be allocated in Manual Therapy (MT) Group for three sessions during 30 minutes. MT treatment will consist in the application of neuromuscular techniques of the temporal, masseter and sternocleidomastoid muscles and Jones techniques in the external pterygoid muscle. Neuromuscular techniques are performed with the index and major fingers to apply a transverse friction with enough pressure to feel vertical fibers of each muscle or produce a medium discomfort level. To perform the Jones technique on the external pterygoid muscle, the patient will be asked to open the mouth and deviate the jaw slightly towards the treated side in order to make room for the finger to be located between the upper jaw and the coronoid process. Once the trigger point is located, we press to trigger the pain and we look for neurological silence and we maintain the pressure for 90 seconds. Over time, we slowly withdraw the pressure and return to the position passively.

Manual Therapy Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Clínica de Fisioterapia y Rehabilitación Miophys S.C.A.

Córdoba, 14009, Spain

Location

Related Publications (3)

• 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.

  PMID: 30517267 RESULT

• 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.

  PMID: 27697769 RESULT

• 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.

  PMID: 25662558 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• María Catalina Osuna Pérez, PhD

  University of Jaén

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 13, 2020
• Study Start: August 11, 2020
• Primary Completion: September 11, 2020
• Study Completion: November 11, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)