Overview

This trial is active, not recruiting.

Condition myofascial pain syndrome
Treatments dry needling, acupuncture needle 0,25 x 40mm
Sponsor University of Sao Paulo General Hospital
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date February 2014
End date February 2015
Trial size 40 participants
Trial identifier NCT02179320, HC-GDOR-MIOFASCIAL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Dry needling for myofascial pain syndrome, in the trapezius muscle.
dry needling
Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm
acupuncture needle 0,25 x 40mm
(Sham Comparator)
Superficial dry needling in the trapezius muscle
dry needling
Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm

Primary Outcomes

Measure
Analgesic effects of dry needling
time frame: Within the first 7 days after treatment

Secondary Outcomes

Measure
Neurologic effects of dry needling
time frame: Within the first 7 days after treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Principal investigator Juliana T Toma, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.