Dry Needling vs Injection in Patients With Temporomandibular Disorders

Temporomandibular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726683
• Other study ID #: URJC-09/2020
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: December 15, 2024

Study information

• Verified date: November 2023
• Source: Universidad Rey Juan Carlos
• Contact: Josue Fernandez Carnero, PhD
• Phone: 914888949
• Email: josue.fernandez[@]urjc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
• 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
• 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.
• 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

Locations

Country	Name	City	State
Spain	Clínica Universitaria de la Universidad Rey Juan Carlos	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Josue Fernandez Carnero

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mandibular Dynamic	Interincisal distance measured in cm.	At baseline, 24h post treatment, at one month, at six months and at twelve months
Secondary	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
Secondary	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
Secondary	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