Trigger Point Dry Needling vs Injection in Patients With Temporomandibular Disorders: a Randomized Placebo-controlled Trial

Josue Fernandez Carnero1 site in 1 country64 target enrollmentNovember 23, 2020

ConditionsTemporomandibular Disorders

Overview

Phase: N/A
Intervention: Not specified
Conditions: Temporomandibular Disorders
Sponsor: Josue Fernandez Carnero
Enrollment: 64
Locations: 1
Primary Endpoint: Pain perception (Change is being assessed)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 23, 2020

End Date

December 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Josue Fernandez Carnero

Responsible Party

Sponsor Investigator

Principal Investigator

Josue Fernandez Carnero

Professor

Universidad Rey Juan Carlos

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Pain perception (Change is being assessed)

Time Frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).

Secondary Outcomes

Beck Depression Inventory (BDI)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Believability of placebo(At one week, at two weeks, at three weeks, at for weeks)
Pain body map(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Conditioned pain modulation(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Central sensitization inventory(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Mandibular Dynamic(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Disability(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Temporal summation (TS)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Fair avoidance beliefs (FAB questionnaire)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Pressure pain threshold (Change is being assessed)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Anxiety (STAI questionnaire)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Expectation of improvement(Baseline, at one week, at two weeks, at three weeks, at for weeks)
Kinesiophobia (TAMPA scale)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
EQ-5D(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Pain catastrophizing (PCS)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
Neuropathic pain(At baseline, 24h post treatment, at one month, at six months and at twelve months)