Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders.
Primary Purpose
Temporomandibular Joint Disorders, Dry Needling, Musculoskeletal Manipulations
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Manual Therapy Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular joint disorders, Dry Needling, Manual Therapy, Orofacial disability, Neck Pain
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.
Sites / Locations
- Clínica de Fisioterapia y Rehabilitación Miophys S.C.A.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry Needling Group
Manual Therapy Treatment
Arm Description
Outcomes
Primary Outcome Measures
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"),
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"),
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"),
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.
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.
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.
Open mouth movements
It will be measured with a validated ruler in centimeters.
Change from Baseline open mouth movements
It will be measured with a validated ruler in centimeters.
Change from Baseline open mouth movements
It will be measured with a validated ruler in centimeters.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04469088
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
September 11, 2020 (Actual)
Study Completion Date
November 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Dry Needling, Musculoskeletal Manipulations
Keywords
Temporomandibular joint disorders, Dry Needling, Manual Therapy, Orofacial disability, Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry Needling Group
Arm Type
Experimental
Arm Title
Manual Therapy Treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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"),
Time Frame
At the beginning of treatment, the first day
Title
Change from Baseline Pain intensity
Description
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"),
Time Frame
At the ended of the first session, after an hour.
Title
Change from Baseline Pain intensity
Description
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"),
Time Frame
At the end of treatment, an average of 2 weeks.
Title
Pain after trigger points pressure
Description
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.
Time Frame
At the beginning of treatment, the first day
Title
Change from Baseline Pain after trigger points pressure
Description
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.
Time Frame
At the ended of the first session, after an hour.
Title
Change from Baseline Pain after trigger points pressure
Description
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.
Time Frame
At the end of treatment, an average of 2 weeks
Title
Open mouth movements
Description
It will be measured with a validated ruler in centimeters.
Time Frame
At the beginning of treatment, the first day
Title
Change from Baseline open mouth movements
Description
It will be measured with a validated ruler in centimeters.
Time Frame
At the ended of the first session, after an hour.
Title
Change from Baseline open mouth movements
Description
It will be measured with a validated ruler in centimeters.
Time Frame
At the end of the tratment, an average of 2 weeks
Title
Neck Disability Index
Description
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.
Time Frame
At the beginning of treatment, the first day.
Title
Change from Baseline Neck Disability Index
Description
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.
Time Frame
At the end of the treatment, an average of 2 weeks
Other Pre-specified Outcome Measures:
Title
Demographic variables
Time Frame
At the beginning of the treatment, the first day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Catalina Osuna Pérez, PhD
Organizational Affiliation
University of Jaén
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica de Fisioterapia y Rehabilitación Miophys S.C.A.
City
Córdoba
ZIP/Postal Code
14009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30517267
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.
Results Reference
result
PubMed Identifier
27697769
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.
Results Reference
result
PubMed Identifier
25662558
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.
Results Reference
result
Learn more about this trial
Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders.
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