Dry Needling vs Injection in Patients With Temporomandibular Disorders
- Conditions
- Temporomandibular Disorders
- Interventions
- Procedure: Injection and placebo dry needlingProcedure: Placebo dry needling and placebo injectionProcedure: Dry needling and placebo injectionProcedure: Dry needling and injection
- Registration Number
- NCT04726683
- Lead Sponsor
- Josue Fernandez Carnero
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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.
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Injection Injection and placebo dry needling Trigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle. Placebo Placebo dry needling and placebo injection Combines sham dry needling + sham injection. Dry needling Dry needling and placebo injection Trigger point dry needling on an active myofascial trigger point of the masseter muscle. Dry needling + Injection Dry needling and injection Combines experimental dry needling and injection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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.
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)
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.
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."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).
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.
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
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).
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).
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
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.
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.
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.
Trial Locations
- Locations (1)
Clínica Universitaria de la Universidad Rey Juan Carlos
🇪🇸Alcorcón, Madrid, Spain