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

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179320
• Other study ID #: HC-GDOR-MIOFASCIAL
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

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

Device:
• acupuncture needle 0,25 x 40mm

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (14)

Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil. 2001 Jul;82(7):986-92. Review. — View Citation

Ga H, Choi JH, Park CH, Yoon HJ. Dry needling of trigger points with and without paraspinal needling in myofascial pain syndromes in elderly patients. J Altern Complement Med. 2007 Jul-Aug;13(6):617-24. — View Citation

Ge HY, Fernández-de-las-Peñas C, Arendt-Nielsen L. Sympathetic facilitation of hyperalgesia evoked from myofascial tender and trigger points in patients with unilateral shoulder pain. Clin Neurophysiol. 2006 Jul;117(7):1545-50. Epub 2006 Jun 5. — View Citation

Ge HY, Fernández-de-Las-Peñas C, Madeleine P, Arendt-Nielsen L. Topographical mapping and mechanical pain sensitivity of myofascial trigger points in the infraspinatus muscle. Eur J Pain. 2008 Oct;12(7):859-65. doi: 10.1016/j.ejpain.2007.12.005. Epub 2008 Jan 18. — View Citation

Gerwin RD. Classification, epidemiology, and natural history of myofascial pain syndrome. Curr Pain Headache Rep. 2001 Oct;5(5):412-20. Review. — View Citation

Giamberardino MA, Affaitati G, Fabrizio A, Costantini R. Myofascial pain syndromes and their evaluation. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):185-98. doi: 10.1016/j.berh.2011.01.002. Review. — View Citation

Giamberardino MA. Referred muscle pain/hyperalgesia and central sensitisation. J Rehabil Med. 2003 May;(41 Suppl):85-8. Review. — View Citation

Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. Review. — View Citation

Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. — View Citation

Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. Review. — View Citation

McCain GA, Bell DA, Mai FM, Halliday PD. A controlled study of the effects of a supervised cardiovascular fitness training program on the manifestations of primary fibromyalgia. Arthritis Rheum. 1988 Sep;31(9):1135-41. — View Citation

Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60. — View Citation

SOLA AE, RODENBERGER ML, GETTYS BB. Incidence of hypersensitive areas in posterior shoulder muscles; a survey of two hundred young adults. Am J Phys Med. 1955 Dec;34(6):585-90. — View Citation

Yap EC. Myofascial pain--an overview. Ann Acad Med Singapore. 2007 Jan;36(1):43-8. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic effects of dry needling	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.	Within the first 7 days after treatment
Secondary	Neurologic effects of dry needling	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.	Within the first 7 days after treatment