Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-21 @ 6:34 PM
Study NCT ID:
NCT02116218
Status:
WITHDRAWN
Last Update Posted:
2020-02-17
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was terminated and the PI has left the institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '15 minutes after intervention', 'description': 'The Visual Analog Scale (VAS) has proven its usefulness and its clinical validity for the evaluation of pain. VAS would be measured and compared before and after intervention.'}, {'measure': 'Heart rate variability', 'timeFrame': '15 minutes after intervention', 'description': 'Autonomic nervous dysfunction plays a role as a consequence of pain. Recording the heart rate variability (HRV) in an easy non-invasive methods to investigate autonomic balance.\n\nHRV would be measured and compared before and after intervention'}], 'secondaryOutcomes': [{'measure': 'Tongue diagnosis', 'timeFrame': '15 minutes after intervention', 'description': 'Tongue diagnosis plays an important role in TCM. In clinical practice Practitioners observed tongue characteristics, such as the color and shape, and the amount of saliva before deducing the primary ailment of a patient.\n\nWe would take photos of tongue before and after intervention to compare the clinical changes.'}, {'measure': 'Brief Pain Inventory', 'timeFrame': '7 days after intervention', 'description': "Brief Pain Inventory (BPI) was made by Pain Research Group in order to measure the pain score of cancer patients.\n\nWe would do the questionnaire before and 7 days after intervention to investigate if there's a long-term effect."}, {'measure': 'adverse event', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 hours.', 'description': 'Participants should report any adverse events they experience, Including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traditional Chinese Medicine', 'acupuncture', 'complementary alternative medicine', 'cancer pain', 'emergency department'], 'conditions': ['Neoplasms', 'Pain']}, 'referencesModule': {'references': [{'pmid': '23341529', 'type': 'BACKGROUND', 'citation': 'Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, Palmer JL, Cohen L. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013 Mar 1;31(7):952-60. doi: 10.1200/JCO.2012.43.5818. Epub 2013 Jan 22.'}, {'pmid': '19009311', 'type': 'BACKGROUND', 'citation': 'Chiu J, Yau T, Epstein RJ. Complications of traditional Chinese/herbal medicines (TCM)--a guide for perplexed oncologists and other cancer caregivers. Support Care Cancer. 2009 Mar;17(3):231-40. doi: 10.1007/s00520-008-0526-x. Epub 2008 Nov 14.'}, {'pmid': '17355955', 'type': 'BACKGROUND', 'citation': 'van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.'}, {'pmid': '16761128', 'type': 'BACKGROUND', 'citation': 'Azevedo Sao Leao Ferreira K, Kimura M, Jacobsen Teixeira M. The WHO analgesic ladder for cancer pain control, twenty years of use. How much pain relief does one get from using it? Support Care Cancer. 2006 Nov;14(11):1086-93. doi: 10.1007/s00520-006-0086-x. Epub 2006 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'Pain control is a common and serious problem in cancer patients. Although WHO has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. When patients are with acute exacerbation or aggravate of pain, they usually visit the emergency department for more help.\n\nAcupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used as a complementary therapy among patients with cancer. It can not only relieve pain in cancer patients, but also can reduce some of the side effects caused by some treatment.\n\nThis study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with acute pain onset through emergency department with objective Traditional Chinese Medicine assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 to 75 years, either gender.\n* Visit emergency department\n* Chief complaint is pain.\n* Diagnosed by oncologist with International Classification of Diseases 9th revision (ICD-9) code between 140.0 to 239.9.\n\nExclusion Criteria:\n\n* Serious comorbid conditions (for example, life-threatening condition).\n* Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.\n* Pregnancy status.'}, 'identificationModule': {'nctId': 'NCT02116218', 'briefTitle': 'Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial', 'orgStudyIdInfo': {'id': 'TCM-2014-ED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture', 'description': 'Experimental group would receive acupuncture at specific acupoints for 15 minutes.', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'seed', 'description': 'Control group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period.', 'interventionNames': ['Procedure: Vaccaria seed']}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'description': "Acupuncture in the Hegu (LI4), Shousanli (LI10), Zusanli (ST36), Yanlinquan (GB34), Taichong (LV3) and Ouch point. Needles would be correctly inserted and manually stimulated until the 'De Qi' sensation is elicited. The needles would stay in place for 15 minutes.", 'armGroupLabels': ['acupuncture']}, {'name': 'Vaccaria seed', 'type': 'PROCEDURE', 'description': 'We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.', 'armGroupLabels': ['seed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}], 'overallOfficials': [{'name': 'Lun-Chien Lo', 'role': 'STUDY_CHAIR', 'affiliation': 'Changhua Christian Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}