Temporomandibular Disorders
Conditions
Keywords
dry needling, Temporomandibular Disorders
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.
Interventions
PROCEDUREDry 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.
PROCEDUREInjection 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
PROCEDUREDry 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.
PROCEDUREPlacebo 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
Sponsors
Josue Fernandez Carnero
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception (Change is being assessed) | 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
| Measure | Time frame | Description |
|---|---|---|
| Disability | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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) | At baseline, 24h post treatment, at one month, at six months and at twelve months | Digital algometer measure of the pressure pain threshold on the masseter muscle |
| Conditioned pain modulation | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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) | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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) | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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) | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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) | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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 |
| Believability of placebo | At one week, at two weeks, at three weeks, at for weeks | 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. |
| Pain catastrophizing (PCS) | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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 | Baseline, at one week, at two weeks, at three weeks, at for weeks | 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 | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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. |
| Mandibular Dynamic | At baseline, 24h post treatment, at one month, at six months and at twelve months | Interincisal distance measured in cm. |
| Neuropathic pain | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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. |
| Pain body map | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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. |
| EQ-5D | At baseline, 24h post treatment, at one month, at six months and at twelve months | . 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. |
| Fair avoidance beliefs (FAB questionnaire) | At baseline, 24h post treatment, at one month, at six months and at twelve months | 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. |
Countries
Spain
Contacts
Primary ContactJosue Fernandez Carnero, PhD
Outcome results
None listed