Clinical trial NCT02179320: Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Official title: Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial Pain Syndrome
Dry needling
Clinical Trial
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesic effects of dry needling
timeFrame: Within the first 7 days after treatment
Secondary outcomes:
measure: Neurologic effects of dry needling
timeFrame: Within the first 7 days after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Daniel C Andrade, M.D., P.h.D.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Juliana T Toma, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Irina Raicher, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Manoel J Teixeira, M.D., P.h.D.
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Helena H Kaziyama, M.D.
role: PRINCIPAL_INVESTIGATOR
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