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

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Myofascial Pain Syndrome

Treatments

Device: acupuncture needle 0,25 x 40mm
Procedure: Dry needling

Study type

Interventional

Funder types

Other

Identifiers

NCT02179320
HC-GDOR-MIOFASCIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Dry needling
Active Comparator group
Description:
Dry needling for myofascial pain syndrome, in the trapezius muscle.
Treatment:
Device: acupuncture needle 0,25 x 40mm
Procedure: Dry needling
Sham needling
Sham Comparator group
Description:
Superficial dry needling in the trapezius muscle
Treatment:
Procedure: Dry needling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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