Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the clinical results produced by a manual therapy treatment combined with dry needling (MT+DN) and a manual therapy treatment (TM) versus a control (C), to normalize the altered cervico-mandibular variables after a session of root canal therapy.

Official Title
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Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention: A Randomized Controlled Trial

Conditions
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Root Canal Therapy, Endodontically Treated Teeth

Intervention / Treatment
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* Other: Manual Therapy + Dry Needling
* Other: Manual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being over 18 years old and requiring an endodontic intervention. Exclusion Criteria: Have received TMJ or cervical treatment during the last month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a randomized controlled trial with 3 different groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy + Dry Needling<br> | Other: Manual Therapy + Dry Needling<br>* Dry Needling: This is a minimally invasive procedure where a fine needle or acupuncture needle is inserted into the skin and muscle in order to stimulate myofascial trigger points (MTrP) provoking one to six local twitch responses (LTR). Manual Therapy Protocol: Intraoral manual techniques were applied to the musculature of both sides, both masseter and medial pterygoid, consisting of both massage and stretching. Furthermore, a grade I-II in the slack-zone traction was applied in the temporomandibular joint (TMJ).<br>|
| Active Comparator: Manual Therapy<br> | Other: Manual Therapy<br>* Manual Therapy Protocol: Intraoral manual techniques were applied to the musculature of both sides, both masseter and medial pterygoid, consisting of both massage and stretching. Furthermore, a grade I-II in the slack-zone traction was applied in the temporomandibular joint (TMJ).<br>|
| No Intervention: Control<br>The control group received only the dentist´s usual advice after endodontic surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Maximum Active Mouth Opening at 1 week | An electronic caliper (HIBOK DC-516) will be used to measure maximum active mouth opening in supine position. Patients will be instructed to open the mouth as wide as possible without feeling any pain and the distance between upper-lower central incisors (intercisal distance) will be measured in mm. | Baseline and 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Pain intensity at 1 week | Pain intensity will be measured using a visual analogue scale (VAS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable). | Baseline and 1 week | 
| Mean change from baseline in Pressure Pain Threshold (PPT) at 1 week | The examiners assess the PPT using a handheld algometer (Wagner, Model FPK). The PPT will be measured bilaterally in the following points of the craniofacial and cervical region: masseter, temporalis, upper trapezius, splenius capitis and suboccipital muscles, and temporomandibular joint. The thenar eminence will be also measured in order to evaluate central sensitization (general pain hypersensitivity) within an intervention-free anatomical location. | Baseline and 1 week | 
| Mean change from baseline in Myofascial Trigger Points (MTrPs) at 1 week | The following muscles of the temporomandibular and cervical regions will be examined: masseter, temporalis, sternocleidomastoid, upper trapezius, splenius capitis and suboccipital muscles. | Baseline and 1 week | 
| Mean change from baseline in Cervical Spine Range of Movement (ROM) at 1 week | The examiners assess the cervical ROM using the Clinometer App (version 2.4) for smartphone and a standard goniometer. Cervical flexion, extension, right/left sidebending, right/left rotation, as well as upper cervical spine flexion and extension will be evaluated. | Baseline and 1 week | 
| Mean change from baseline in TMD-Pain Screener (TMJ Function) at 1 week | The examiners assess temporomandibular disorders (TMDs) using this screening instrument f | Baseline and 1 week | 
| Mean change from baseline in Helkimo Index (TMJ Function) at 1 week | The examiners assess the severity and pain of TMDs patients using the Helkimo Index. | Baseline and 1 week | 
| Mean change from baseline in Jaw Functional Limitation Scale (JFLS-20) (TMJ Function) | The examiners assess the functional limitation globally during the last month using the JFLS-20. Subjects must indicate the level of limitation during the last week in a range from 0 to 10. | Baseline and 1 week | 
| Mean change from baseline in Neck Disability Index (NDI) (Neck Function) at 1 week | The examiners assess the self-perceived disability from neck pain using the NDI. | Baseline and 1 week | 
| Mean change from baseline in Headache Impact Test (HIT-6) (Headache Disfunction) at 1 week | The examiners assess the impact of headache on patients' lives using the HIT-6. | Baseline and 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Needling, Manual Therapy, Temporomandibular Joint, Cervical spine, Root Canal Therapy