Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome

Study Overview
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Brief Summary
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AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS) patients.

Detailed Description
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This study will be performed in patients with shoulder pain due to excess of nociception associated with chronic Myofascial Pain Syndrome in asymmetrical unilateral trapezius muscle trigger points. Patients will be randomly assigned to two treatment arms: Active (A) (n=20) and Sham (S) (n=21). Group A will receive actual treatment with trigger point dry needling. Group S will receive a sham treatment, with the needle inserted superficially in the skin, without reaching the muscle underneath it. The duration and pain elicited during active and sham dry needling will be controlled for. Patients will be evaluated one week before needling (D-7), on the day of dry needling (D0) and seven days after the procedure (D+7). Patients will fill out the Brazilian version of the Douleur Neuropathique 4, Beck Depression Inventory, Brief Pain Inventory (BPI), McGill Pain Questionnaire-SF (SFMPQ), Hospital Anxiety and Depression Scale and Global Impression of Change, and also a 14-day Carnet to more accurately evaluate their daily pain before and after the treatment. For the evaluation of neurologic changes, we will evaluate local hyperalgesia, tactile, mechanical, static and thermal sensitivity with thermal quantitative sensorial testing (TQS), and also mapping of the painful area, before and after treatment in both D0 and D+7.

Official Title
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Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome

Conditions
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Myofascial Pain Syndrome

Intervention / Treatment
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* Procedure: Dry needling
* Device: acupuncture needle 0,25 x 40mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Assymetric shoulder pain (VAS on painful side : VAS on non painful side > 2:1) Pain due to unilateral Myofascial Pain Syndrome of the trapezius muscle. Chronic pain, with duration of at least 3 months and VAS > 40/100 Patients with pain at least 4 days in a week Patients without neurological pain, as in DN4 score less than 4 Age over 18 years Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study Patients who read, understood and signed the Free and Clarified Consent Term Exclusion Criteria: Patients with major depression, according to DSM-IV criteria History of bipolar mood disorder, panic syndrome or psychosis Intermittent pain history Refusal to sing the Consent Term Patients not able to attend all the follow-ups Patients with another pain syndrome in shoulders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dry needling<br>Dry needling for myofascial pain syndrome, in the trapezius muscle. | Procedure: Dry needling<br>* Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm<br>Device: acupuncture needle 0,25 x 40mm<br> <br> |
| Sham Comparator: Sham needling<br>Superficial dry needling in the trapezius muscle | Procedure: Dry needling<br>* Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic effects of dry needling | Maximum, average and lowest pain will be evaluated daily 7 days before the treatment, on the day of the treatment, and also 7 days after the treatment is done. | Within the first 7 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic effects of dry needling | Tactile, mechanical, static and thermal sensitivity will be evaluated with thermal quantitative sensorial testing, as well as hyperalgesia. The painful area will also be mapped to compara before and after treatment results. | Within the first 7 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial Pain Syndrome, Dry needling, Clinical Trial