Dry Needling vs Injection in Patients With Temporomandibular Disorders

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• Temporomandibular Joint Disorders 621

Keywords

• dry needling
• Temporomandibular Disorders

Temporomandibular Joint Disorders

621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.

This study's planned enrollment of 64 is above the median of 46 across 439 interventional studies indexed under Temporomandibular Joint Disorders.

Lead sponsor

Josue Fernandez Carnero is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  Dry needling

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

  Procedure: Dry needling and placebo injection

• Experimental
  Injection

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

  Procedure: Injection and placebo dry needling

• Placebo comparator
  Placebo

  Combines sham dry needling + sham injection.

  Procedure: Placebo dry needling and placebo injection

• Active comparator
  Dry needling + Injection

  Combines experimental dry needling and injection

  Procedure: Dry needling and injection

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

Primary outcomes

1. Pain perception (Change is being assessed)

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

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

Secondary outcomes

1. 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.

   Time frame: At one week, at two weeks, at three weeks, at for weeks

2. 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."

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

3. Pressure pain threshold (Change is being assessed)

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

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

4. 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)

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

5. 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).

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

6. 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.

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

7. 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).

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

8. 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

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

9. 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.

   Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

10. 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.

    Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

11. 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).

    Time frame: Baseline, at one week, at two weeks, at three weeks, at for weeks

12. 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.

    Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

13. Mandibular Dynamic

    Interincisal distance measured in cm.

    Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

14. 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.

    Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

15. 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.

    Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months

16. 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.

    Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months