Dry Needling vs Injection in Patients With Temporomandibular Disorders

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Dry needling and placebo injection

Injection and placebo dry needling

Dry needling and injection

Placebo dry needling and placebo injection

About this trial

This is an interventional treatment trial for Temporomandibular Disorders focused on measuring dry needling, Temporomandibular Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Craniofacial pain
Myofascial temporomandibular disorders

Exclusion Criteria:

Previous injection (3 months) or dry needling intervention on the masseter
Temporomandibular disc joint pathology
History of trauma, infection in the temporomandibular joint in the last 6 months
Coagulation disorders
Pregnancy

Sites / Locations

Clínica Universitaria de la Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Dry needling

Injection

Placebo

Dry needling + Injection

Arm Description

Trigger point dry needling on an active myofascial trigger point of the masseter muscle.

Trigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle.

Combines sham dry needling + sham injection.

Combines experimental dry needling and injection

Outcomes

Primary Outcome Measures

Pain perception (Change is being assessed)

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

Secondary Outcome Measures

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.

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."

Pressure pain threshold (Change is being assessed)

Digital algometer measure of the pressure pain threshold on the masseter muscle

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)

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).

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.

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).

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

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.

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.

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).

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.

Full Information

NCT ID

NCT04726683

First Posted

November 13, 2020

Last Updated

November 23, 2022

Sponsor

Josue Fernandez Carnero

1. Study Identification

Unique Protocol Identification Number

NCT04726683

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

November 23, 2020 (Actual)

Primary Completion Date

November 23, 2021 (Actual)

Study Completion Date

September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Josue Fernandez Carnero

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Disorders

Keywords

dry needling, Temporomandibular Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dry needling

Arm Type

Experimental

Arm Description

Trigger point dry needling on an active myofascial trigger point of the masseter muscle.

Arm Title

Injection

Arm Type

Experimental

Arm Description

Trigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Combines sham dry needling + sham injection.

Arm Title

Dry needling + Injection

Arm Type

Active Comparator

Arm Description

Combines experimental dry needling and injection

Intervention Type

Procedure

Intervention Name(s)

Dry needling and placebo injection

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Injection and placebo dry needling

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Dry needling and injection

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Placebo dry needling and placebo injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain perception (Change is being assessed)

Description

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

Time Frame

Baseline to 12 months

Secondary Outcome Measure Information:

Title

Believability of placebo

Description

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.

Time Frame

1 month

Title

Disability

Description

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."

Time Frame

Baseline to 12 months

Title

Pressure pain threshold (Change is being assessed)

Description

Digital algometer measure of the pressure pain threshold on the masseter muscle

Time Frame

Baseline to 12 months

Title

Conditioned pain modulation

Description

Pressure pain thresholds measure on the distal phalanx of the thumb before and during the application of a noxious stimulus ( Ischemic pain)

Time Frame

Baseline to 12 months

Title

Temporal summation (TS)

Description

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).

Time Frame

Baseline to 12 months

Title

Beck Depression Inventory (BDI)

Description

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.

Time Frame

Baseline to 12 months

Title

Anxiety (STAI questionnaire)

Description

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).

Time Frame

Baseline to 12 months

Title

Kinesiophobia (TAMPA scale)

Description

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

Time Frame

Baseline to 12 months

Title

Fair avoidance beliefs (FAB questionnaire)

Description

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.

Time Frame

Baseline to 12 months

Title

Pain catastrophizing (PCS)

Description

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.

Time Frame

Baseline to 12 months

Title

Expectation of improvement

Description

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).

Time Frame

Baseline to one week

Title

Central sensitization inventory

Description

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.

Time Frame

Baseline to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Craniofacial pain Myofascial temporomandibular disorders Exclusion Criteria: Previous injection (3 months) or dry needling intervention on the masseter Temporomandibular disc joint pathology History of trauma, infection in the temporomandibular joint in the last 6 months Coagulation disorders Pregnancy

Facility Information:

Facility Name

Clínica Universitaria de la Universidad Rey Juan Carlos

City

Alcorcón

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Temporomandibular Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial