Dry Needling vs Injection in Patients With Temporomandibular Disorders

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

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Disorders
• Intervention / Treatment: Procedure: Dry needling and placebo injection; Procedure: Injection and placebo dry needling; Procedure: Placebo dry needling and placebo injection; Procedure: Dry needling and injection

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josue Fernandez Carnero, PhD; Phone Number: 914888949; Email: josue.fernandez@urjc.es

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Recruiting
      • Clínica Universitaria de la Universidad Rey Juan Carlos
      • Contact: Josue Fernandez-Carnero, Phd; Phone Number: +34 91 4888949; Email: josue.fernandez@urjc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling; Trigger point dry needling on an active myofascial trigger point of the masseter muscle.	Procedure: Dry needling and placebo injection; Dry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin.
Experimental: Injection; Trigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle.	Procedure: Injection and placebo dry needling; Lidocaine injection applied in the myofascial trigger point of the masseter muscle. Lidocaine injection is combined with placebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin
Placebo Comparator: Placebo; Combines sham dry needling + sham injection.	Procedure: Placebo dry needling and placebo injection; Placebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin. Placebo dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin
Active Comparator: Dry needling + Injection; Combines experimental dry needling and injection	Procedure: Dry needling and injection; Dry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with lidocaine injection applied in the myofascial trigger point of the masseter muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception (Change is being assessed)	Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).	At baseline, 24h post treatment, at one month, at six months and at twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Believability of placebo	Patients beliefs about group allocation: A scale of cale of four options (Experimental Dry needling / Experimental Injection / Placebo Comparator / Active Comparator) in which patients had to indicate which intervention they believe they have received during the treatment sessions.	At one week, at two weeks, at three weeks, at for weeks
Disability	Self-reported disability questionnaire: Craniofacial Pain and Disability Inventory (CF-PDI). The CF-PDI contains 21 items divided into 2 subscales according to their content and exploratory factor analysis: "pain and disability" and "jaw functional status."	At baseline, 24h post treatment, at one month, at six months and at twelve months
Pressure pain threshold (Change is being assessed)	Digital algometer measure of the pressure pain threshold on the masseter muscle	At baseline, 24h post treatment, at one month, at six months and at twelve months
Conditioned pain modulation	Pressure pain thresholds measure on the distal phalanx of the thumb before and during the application of a noxious stimulus ( Ischemic pain)	At baseline, 24h post treatment, at one month, at six months and at twelve months
Temporal summation (TS)	Initially, a needlle stimulus is measured locally and distally. Then, the TS is triggered by 10 consecutive pressures on the PPT at the pressure determined at each location. For each pulse, the pressure was gradually increased at a rate of 2 kg/s at the determined PPT and held for 1 s before being released (with an interval of one second between each stimulus).	At baseline, 24h post treatment, at one month, at six months and at twelve months
Beck Depression Inventory (BDI)	The level of depressive symptomatology was measured by the Spanish version of the Beck Depression Inventory (BDI-II); a 21-item self-report rating scale that assesses affective, cognitive and somatic symptoms of depression. Each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.	At baseline, 24h post treatment, at one month, at six months and at twelve months
Anxiety (STAI questionnaire)	The state-trait anxiety inventory (STAI) is a questionnaire that measures trait anxiety (a personality factor that predisposes the patient to suffer from anxiety) and the state of anxiety (environmental factors that protect or generate anxiety). Each of the two sub-scales (trait anxiety and state anxiety) consists of 20 items, ranging from 0 (nothing) to 3 (a lot).	At baseline, 24h post treatment, at one month, at six months and at twelve months
Kinesiophobia (TAMPA scale)	Tampa Scale for Kinesiophobia. To assess the fear of movement and pain-related fear. The 11 items are scored 1-4, with total scores ranging from 11 to 44. The addition of all the points obtained from each of the items results in the level of kinesiophobia, with higher scores indicating greater perceived kinesiophobia	At baseline, 24h post treatment, at one month, at six months and at twelve months
Fair avoidance beliefs (FAB questionnaire)	Fear-avoidance Beliefs Questionnaire . The instrument consists of two subscales, a four-item physical activity subscale, and a seven-item work subscale. Each item is scored from 0 to 6 and summed to produce the subscale score. Possible scores range from 0-28 to 0-42, with higher scores indicating greater fear avoidance beliefs.	At baseline, 24h post treatment, at one month, at six months and at twelve months
Pain catastrophizing (PCS)	Pain catastrophizing Scale (PCS). This tool is a 13-item questionnaire designed to measure the three components of pain-related catastrophizing: rumination, magnification, and helplessness, resulting in a unique score. Each item is responded to on a 5-point scale (0 not at all, 4 all the time) relating the degree to which the individual experiences a thought or feeling of a painful situation.	At baseline, 24h post treatment, at one month, at six months and at twelve months
Expectation of improvement	Patients´ expectations of pain improvement after the intervention. Patients report their estimated pain perception after the treatment by completing a Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).	Baseline, at one week, at two weeks, at three weeks, at for weeks
Central sensitization inventory	It serves to identify the symptoms related to central sensitization. It consists of 25 items that are scored from 0: never to 4: always reaching a maximum score of 100. Results are interpreted as follows: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100.	At baseline, 24h post treatment, at one month, at six months and at twelve months
Mandibular Dynamic	Interincisal distance measured in cm.	At baseline, 24h post treatment, at one month, at six months and at twelve months
Neuropathic pain	The presence of neuropathic pain will be assessed using the DN4 questionnaire validated in Spanish. This clinician-administered questionnaire consists of 10 questions. Seven of them are related to the quality of pain and are based on the patient interview, and the remaining three are based on clinical examination according to the presence or absence of hypoesthesia and tactile allodynia to pressure and touch.	At baseline, 24h post treatment, at one month, at six months and at twelve months
Pain body map	The patient will be asked to paint the areas where he/she presents pain. This map consists of a representation of a person drawn in an anterior, posterior and two lateral planes. The drawing is in a grid of 10mm x 10mm, 16mm x 16 mm cells, up to a maximum of 256 cells.	At baseline, 24h post treatment, at one month, at six months and at twelve months
EQ-5D	. It consists of two parts: the descriptive EQ-5D system and the VAS. It is a generic and standardized questionnaire, self-administered, simple to answer and with low cognitive load.	At baseline, 24h post treatment, at one month, at six months and at twelve months

Collaborators and Investigators

• Sponsor: Josue Fernandez Carnero

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: dry needling; Temporomandibular Disorders
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: URJC-09/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No