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Clinical Trials/NCT02179320
NCT02179320
Completed
N/A

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

University of Sao Paulo General Hospital1 site in 1 country40 target enrollmentFebruary 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myofascial Pain Syndrome
Sponsor
University of Sao Paulo General Hospital
Enrollment
40
Locations
1
Primary Endpoint
Analgesic effects of dry needling
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
February 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Analgesic effects of dry needling

Time Frame: Within the first 7 days after treatment

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.

Secondary Outcomes

  • Neurologic effects of dry needling(Within the first 7 days after treatment)

Study Sites (1)

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