Back to resultsDry Needling and Spinal Manipulation vs. Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
Primary Purpose
Temporomandibular Joint Dysfunction Syndrome
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Dry Needling
Spinal manipulation
Interocclusal Appliance
NSAIDs
TMJ Mobs
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients at least 18 years old
- Patient referred to physical therapy from a physician or dentist with a diagnosis of temporomandibular dysfunction that is consistent with the Revised TMD Group 1 Muscle Disorders Diagnostic Algorithm. (Dworkin et al.1992; Look et al., 2010]. According to Blanco-Hungria et al. (2015), this category represents 88.7% of patients with TMD.
- History of symptoms related to TMD for at least 3 months
- Intensity of pain related to TMD at least 30mm out 100 per Visual Analogue scale (La Touche et al, 2009; Gonzalez-Ingesias et al., 2013)
Patient presents with the following: (Gonzalez Perez et al., 2015)
- Strong pain in the anterior part of the lower belly of the LPM on palpation
- Deep-seated pain in the TMJ and/or region of the maxillary sinus (referred pain)
- Significant motor dysfunction (e.g. limited jaw opening, painful protrusion of the chin against resistance, mandibular lateralization to the opposite side upon opening).
Exclusion Criteria:
- Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- Signs or symptoms of disc displacement, arthrosis or arthritis of the temporomandibular joint according to category II and III of the Research Diagnostic Criteria for Temporomandibular Disorders
- History of traumatic injury such as a fracture or whiplash
- Concomitant diagnosis of any primary headache (i.e. tension type headache or Migraine) except cervicogenic headaches
- History of surgery related to TMD
- Diagnosis of fibromyalgia
- Systemic disease such as RA, lupus erythematosus or psoriatic arthritis
- Presence of neurological disorder such as trigeminal neuralgia
- History of PT, acupuncture or splint treatment within 3 months of the study
- History of taking prescription NSAIDs within 3 months of the study
- History of regularly taking non-prescription NSAIDs (i.e. more than intermittent) within 3 months of the study
- Known sensitivity to acetylsalicylic acid, with impaired coagulation or with ulcer, kidney or liver problems.
- Cadiac pacemaker, metal allergy or severe needle phobia
- Serious cardiovascular, cerebral disease, psychiatric disorder or cognitive Impairment
- Pregnancy
Sites / Locations
- Physiomed-lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry Needling and Spinal Manipulation
Interocclusal Appliance, NSAIDs and TMJ Mobs
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Change in average jaw pain intensity rated by the patient over last 24 hours and last 7 days (VAS: 0-100mm) between baseline and the following time points: 2 weeks, 6 weeks and 3 months.
Even though patients will be treated 1-2 treatments per week for 4 weeks (up to 8 treatments total), the visual analogue score after 2 weeks of treatment, at 6 weeks (2 weeks post treatment) and at 3 months (2 months post treatment) will be compared to baseline (pre-treatment). Scores closer to 0 represent less pain.
Secondary Outcome Measures
Global Rating of Perceived Change
Global rating of perceived change rated rated by the patient according to a -7 to +7 scale. More specifically, the Global Rating of Perceived Change is rated as follows:
A very great deal worse (-7)
A great deal worse (-6)
Quite a bit worse (-5)
Moderately worse (-4)
Somewhat worse (-3)
A little bit worse (-2)
A tiny bit worse (almost the same) (-1)
About the same (0)
A very great deal better (+7)
A great deal better (+6)
Quite a bit better (+5)
Moderately better (+4)
Somewhat better (+3)
A little bit better (+2)
A tiny bit better (almost the same) (+1)
The patient will choose a rating (the closer to +7, the better the score / the closer to -7, the worse the score) after 2 weeks of treatment, at 6 weeks (2 weeks post-treatment) and 3 months (2 months post-treatment).
Active Pain Free Mouth Opening
Change in the distance between upper and lower central incisors after patient has opening mouth "as wide as possible" without causing pain between baseline and the following time points: 2 weeks, 6 weeks and 3 months. Measurements will be taken in mm. The greater the distance, the better the score.
Even though patients will be treated 1-2 treatments per week for 4 weeks (up to 8 treatments total), active pain free mouth opening after 2 weeks of treatment, at 6 weeks (2 weeks post treatment) and at 3 months (2 months post treatment) will be compared to baseline (pre-treatment)
Greater scores represent greater pain free mouth opening.
Full Information
NCT ID
NCT03409874
First Posted
January 10, 2018
Last Updated
December 28, 2020
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT03409874
Brief Title
Dry Needling and Spinal Manipulation vs. Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
Official Title
Dry Needling and Spinal Manipulation or Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to compare two different approaches for treating patients with temporomandibular dysfunction (TMD): Dry needling and spinal manipulation or Interocclusal Appliance (Splint), NSAIDs and Temporomandibular Joint Mobilization . Clinicians commonly use all of these techniques to treat TMD. This study is attempting to find out if one treatment strategy is more effective than the other.
Detailed Description
Patients with stress temporomandibular dysfunction will be randomized to receive 1-2 treatment sessions per week for up to 4 weeks ( up to 8 sessions total) of either: (1) dry needling and spinal manipulation or (2) Interocclusal appliance (splint), NSAIDs, temporomandibular joint mobilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry Needling and Spinal Manipulation
Arm Type
Experimental
Arm Title
Interocclusal Appliance, NSAIDs and TMJ Mobs
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
Dry needling to the muscle of mastication and temporomandibular joint capsule. 1-2 treatment sessions per week for up to 4 weeks
Intervention Type
Other
Intervention Name(s)
Spinal manipulation
Intervention Description
Spinal manipulation, targeting the upper cervical spine (C1-C2, C2-C3 or OA). 1-2 treatments per week for up to 4 weeks.
Intervention Type
Other
Intervention Name(s)
Interocclusal Appliance
Other Intervention Name(s)
splint
Intervention Description
Interocclusal appliance worn every nights for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
NSAIDs
Other Intervention Name(s)
diclofenac, Voltaren
Intervention Description
diclofenac (Voltaren) 3 X 50mg per day for 4 weeks. If the patient's TMJ pain improves, the dosage may be reduced to 2 X 50mg per day.
Intervention Type
Other
Intervention Name(s)
TMJ Mobs
Intervention Description
Temporomandibular joint mobilization targeting the temporomandibular joint capsule. 1-2 treatments per week for up to 4 weeks.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Change in average jaw pain intensity rated by the patient over last 24 hours and last 7 days (VAS: 0-100mm) between baseline and the following time points: 2 weeks, 6 weeks and 3 months.
Even though patients will be treated 1-2 treatments per week for 4 weeks (up to 8 treatments total), the visual analogue score after 2 weeks of treatment, at 6 weeks (2 weeks post treatment) and at 3 months (2 months post treatment) will be compared to baseline (pre-treatment). Scores closer to 0 represent less pain.
Time Frame
baseline, 2 weeks, 6 weeks, 3 months
Secondary Outcome Measure Information:
Title
Global Rating of Perceived Change
Description
Global rating of perceived change rated rated by the patient according to a -7 to +7 scale. More specifically, the Global Rating of Perceived Change is rated as follows:
A very great deal worse (-7)
A great deal worse (-6)
Quite a bit worse (-5)
Moderately worse (-4)
Somewhat worse (-3)
A little bit worse (-2)
A tiny bit worse (almost the same) (-1)
About the same (0)
A very great deal better (+7)
A great deal better (+6)
Quite a bit better (+5)
Moderately better (+4)
Somewhat better (+3)
A little bit better (+2)
A tiny bit better (almost the same) (+1)
The patient will choose a rating (the closer to +7, the better the score / the closer to -7, the worse the score) after 2 weeks of treatment, at 6 weeks (2 weeks post-treatment) and 3 months (2 months post-treatment).
Time Frame
2 weeks, 6 weeks, 3 months
Title
Active Pain Free Mouth Opening
Description
Change in the distance between upper and lower central incisors after patient has opening mouth "as wide as possible" without causing pain between baseline and the following time points: 2 weeks, 6 weeks and 3 months. Measurements will be taken in mm. The greater the distance, the better the score.
Even though patients will be treated 1-2 treatments per week for 4 weeks (up to 8 treatments total), active pain free mouth opening after 2 weeks of treatment, at 6 weeks (2 weeks post treatment) and at 3 months (2 months post treatment) will be compared to baseline (pre-treatment)
Greater scores represent greater pain free mouth opening.
Time Frame
baseline, 2 weeks, 6 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at least 18 years old
Patient referred to physical therapy from a physician or dentist with a diagnosis of temporomandibular dysfunction that is consistent with the Revised TMD Group 1 Muscle Disorders Diagnostic Algorithm. (Dworkin et al.1992; Look et al., 2010]. According to Blanco-Hungria et al. (2015), this category represents 88.7% of patients with TMD.
History of symptoms related to TMD for at least 3 months
Intensity of pain related to TMD at least 30mm out 100 per Visual Analogue scale (La Touche et al, 2009; Gonzalez-Ingesias et al., 2013)
Patient presents with the following: (Gonzalez Perez et al., 2015)
Strong pain in the anterior part of the lower belly of the LPM on palpation
Deep-seated pain in the TMJ and/or region of the maxillary sinus (referred pain)
Significant motor dysfunction (e.g. limited jaw opening, painful protrusion of the chin against resistance, mandibular lateralization to the opposite side upon opening).
Exclusion Criteria:
Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
Signs or symptoms of disc displacement, arthrosis or arthritis of the temporomandibular joint according to category II and III of the Research Diagnostic Criteria for Temporomandibular Disorders
History of traumatic injury such as a fracture or whiplash
Concomitant diagnosis of any primary headache (i.e. tension type headache or Migraine) except cervicogenic headaches
History of surgery related to TMD
Diagnosis of fibromyalgia
Systemic disease such as RA, lupus erythematosus or psoriatic arthritis
Presence of neurological disorder such as trigeminal neuralgia
History of PT, acupuncture or splint treatment within 3 months of the study
History of taking prescription NSAIDs within 3 months of the study
History of regularly taking non-prescription NSAIDs (i.e. more than intermittent) within 3 months of the study
Known sensitivity to acetylsalicylic acid, with impaired coagulation or with ulcer, kidney or liver problems.
Cadiac pacemaker, metal allergy or severe needle phobia
Serious cardiovascular, cerebral disease, psychiatric disorder or cognitive Impairment
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiomed-lab
City
Thessaloníki
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dry Needling and Spinal Manipulation vs. Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
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