Clinical trial NCT04726683: Dry Needling vs Injection in Patients With Temporomandibular Disorders
Official title: Trigger Point Dry Needling vs Injection in Patients With Temporomandibular Disorders: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders
Keywords: dry needling
Temporomandibular Disorders
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to compare the effectiveness of dry needling in improving pain and disability versus placebo, and versus infiltration, in patients with myofascial temporomandibular dysfunction in the short, medium and long term.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged between 18 and 60 years.
2. Pain of more than 6 weeks of evolution in the craniofacial region.
3. TMD with origin in the masticatory musculature according to the "DC-TMD" criteria.

Exclusion Criteria:

1. Previous injection or dry needling intervention (3 months) on the masseter muscle.
2. Arthrogenous TMD.
3. History of trauma, infection in the temporomandibular joint in the last 6 months.
4. Coagulation disorders.
5. Pregnancy.

Primary outcomes:
measure: Pain perception (Change is being assessed)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Secondary outcomes:
measure: Believability of placebo
timeFrame: At one week, at two weeks, at three weeks, at for weeks
measure: Disability
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Pressure pain threshold (Change is being assessed)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Conditioned pain modulation
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Temporal summation (TS)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Beck Depression Inventory (BDI)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Anxiety (STAI questionnaire)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Kinesiophobia (TAMPA scale)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Fair avoidance beliefs (FAB questionnaire)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Pain catastrophizing (PCS)
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Expectation of improvement
timeFrame: Baseline, at one week, at two weeks, at three weeks, at for weeks
measure: Central sensitization inventory
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Mandibular Dynamic
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Neuropathic pain
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: Pain body map
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
measure: EQ-5D
timeFrame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Clínica Universitaria de la Universidad Rey Juan Carlos
state: Madrid
Study officials:
References: