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NCT Number: NCT02179320

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

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Procedure

Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm

acupuncture needle 0,25 x 40mm

Device

Primary outcomes

  1. 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

  1. Neurologic effects of dry needling

    Time frame: Within the first 7 days after treatment

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2014
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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