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

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ClinicalTrials.gov Identifier: NCT02179320
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndrome Procedure: Dry needling Device: acupuncture needle 0,25 x 40mm Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Actual Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Dry needling
Dry needling for myofascial pain syndrome, in the trapezius muscle.
Procedure: Dry needling
Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm

Device: acupuncture needle 0,25 x 40mm
Sham Comparator: Sham needling
Superficial dry needling in the trapezius muscle
Procedure: Dry needling
Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179320


Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Daniel C Andrade, M.D., P.h.D. University of Sao Paulo
Principal Investigator: Juliana T Toma, M.D. University of Sao Paulo
Principal Investigator: Irina Raicher, M.D. University of Sao Paulo
Study Director: Manoel J Teixeira, M.D., P.h.D. University of Sao Paulo
Principal Investigator: Helena H Kaziyama, M.D. University of Sao Paulo

Publications:

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02179320     History of Changes
Other Study ID Numbers: HC-GDOR-MIOFASCIAL
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2015

Keywords provided by University of Sao Paulo General Hospital:
Myofascial Pain Syndrome
Dry needling
Clinical Trial

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Myofascial Pain Syndromes
Fibromyalgia
Disease
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases