Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-03 @ 5:54 AM
Study NCT ID:
NCT02179320
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2014-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-06-30', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic effects of dry needling', 'timeFrame': 'Within the first 7 days after treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Neurologic effects of dry needling', 'timeFrame': 'Within the first 7 days after treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myofascial Pain Syndrome', 'Dry needling', 'Clinical Trial'], 'conditions': ['Myofascial Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '17285185', 'type': 'BACKGROUND', 'citation': 'Yap EC. Myofascial pain--an overview. Ann Acad Med Singap. 2007 Jan;36(1):43-8.'}, {'pmid': '11560806', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17718644', 'type': 'BACKGROUND', '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. doi: 10.1089/acm.2006.6371.'}, {'pmid': '11441390', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '3048273', 'type': 'BACKGROUND', '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. doi: 10.1002/art.1780310908.'}, {'pmid': '12817663', 'type': 'BACKGROUND', 'citation': 'Giamberardino MA. Referred muscle pain/hyperalgesia and central sensitisation. J Rehabil Med. 2003 May;(41 Suppl):85-8. doi: 10.1080/16501960310010205.'}, {'pmid': '16737848', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9685106', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16945250', 'type': 'BACKGROUND', 'citation': 'Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.'}, {'pmid': '22094195', 'type': 'BACKGROUND', '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.'}, {'pmid': '2788962', 'type': 'BACKGROUND', '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.'}, {'pmid': '13268620', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '8043247', 'type': 'BACKGROUND', '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. doi: 10.1097/00002060-199407000-00006.'}, {'pmid': '18203637', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.\n\nThe 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).\n\nPatients 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Assymetric shoulder pain (VAS on painful side : VAS on non painful side \\> 2:1)\n* Pain due to unilateral Myofascial Pain Syndrome of the trapezius muscle.\n* Chronic pain, with duration of at least 3 months and VAS \\> 40/100\n* Patients with pain at least 4 days in a week\n* Patients without neurological pain, as in DN4 score less than 4\n* Age over 18 years\n* Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study\n* Patients who read, understood and signed the Free and Clarified Consent Term\n\nExclusion Criteria:\n\n* Patients with major depression, according to DSM-IV criteria\n* History of bipolar mood disorder, panic syndrome or psychosis\n* Intermittent pain history\n* Refusal to sing the Consent Term\n* Patients not able to attend all the follow-ups\n* Patients with another pain syndrome in shoulders'}, 'identificationModule': {'nctId': 'NCT02179320', 'briefTitle': 'Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome', 'orgStudyIdInfo': {'id': 'HC-GDOR-MIOFASCIAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dry needling', 'description': 'Dry needling for myofascial pain syndrome, in the trapezius muscle.', 'interventionNames': ['Procedure: Dry needling', 'Device: acupuncture needle 0,25 x 40mm']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham needling', 'description': 'Superficial dry needling in the trapezius muscle', 'interventionNames': ['Procedure: Dry needling']}], 'interventions': [{'name': 'Dry needling', 'type': 'PROCEDURE', 'description': 'Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm', 'armGroupLabels': ['Dry needling', 'Sham needling']}, {'name': 'acupuncture needle 0,25 x 40mm', 'type': 'DEVICE', 'armGroupLabels': ['Dry needling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Daniel C Andrade, M.D., P.h.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Juliana T Toma, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Irina Raicher, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Manoel J Teixeira, M.D., P.h.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Helena H Kaziyama, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}