Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
NCT ID: NCT02179320
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2014-02-28
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Impact of Dry Needling on Electrophysiological and Ultrasound-based Biomarkers for Myofascial Pain
NCT07270276
Dry Needling Versus Intramuscular Stimulation in the Management of the Myofascial Trigger Points
NCT03025230
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
NCT02190890
Effectiveness of Dry Needling in Shortened Triceps Surae Muscle
NCT03273985
The Effects of Dry Needling on the Superficial Neck Musculature
NCT04060004
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dry needling
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 needling
Superficial dry needling in the trapezius muscle
Dry needling
Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dry needling
Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm
acupuncture needle 0,25 x 40mm
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel C Andrade, M.D., P.h.D.
Role: STUDY_CHAIR
University of Sao Paulo
Juliana T Toma, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Irina Raicher, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Manoel J Teixeira, M.D., P.h.D.
Role: STUDY_DIRECTOR
University of Sao Paulo
Helena H Kaziyama, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yap EC. Myofascial pain--an overview. Ann Acad Med Singap. 2007 Jan;36(1):43-8.
Gerwin RD. Classification, epidemiology, and natural history of myofascial pain syndrome. Curr Pain Headache Rep. 2001 Oct;5(5):412-20. doi: 10.1007/s11916-001-0052-8.
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. doi: 10.1089/acm.2006.6371.
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. doi: 10.1053/apmr.2001.24023.
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. doi: 10.1002/art.1780310908.
Giamberardino MA. Referred muscle pain/hyperalgesia and central sensitisation. J Rehabil Med. 2003 May;(41 Suppl):85-8. doi: 10.1080/16501960310010205.
Ge HY, Fernandez-de-las-Penas 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. doi: 10.1016/j.clinph.2006.03.026. Epub 2006 Jun 5.
Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. doi: 10.1016/s0003-9993(98)90371-9.
Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.
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.
Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60.
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. No abstract available.
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. doi: 10.1097/00002060-199407000-00006.
Ge HY, Fernandez-de-Las-Penas 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HC-GDOR-MIOFASCIAL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.