Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:44 PM
Study NCT ID:
NCT04703803
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2021-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Myofascial Pain Syndrome Treatment in Patients With Cancer in Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'A member of the research team who doesn´t know whether the participant is in the intervention or control group will be responsible for the reassessment (after 72 hours and 1 week) to measure the outcomes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, comparative, single-blinded interventional study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-22', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity', 'timeFrame': '72 hours and 7 days', 'description': 'Assessed by Visual Analogic Scale (0 to 10). This evaluation will be collected at baseline, after 72 hours and after 7 days in follow-up.'}], 'secondaryOutcomes': [{'measure': 'Change in pain threshold measurement', 'timeFrame': '72 hours and 7 days', 'description': 'Assessed with a pressure gauge (Kg). This evaluation will be collected at baseline, after 72 hours and after 7 days in follow-up.'}, {'measure': 'Change in number of analgesic drugs in use', 'timeFrame': '72 hours and 7 days', 'description': 'Evaluation of the number of drugs in use, if there was an increase, reduction or maintenance of the number and doses of analgesic drugs comparing to the baseline.'}, {'measure': 'Assessment of depression and anxiety simptoms', 'timeFrame': '7 days', 'description': 'Assessed by Hospital Anxiety and Depression Scale- scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores mean worse outcome.'}, {'measure': 'Assessment of quality of life', 'timeFrame': '7 days', 'description': 'Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnarie Core 15 PAL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myofascial Pain Syndromes', 'Cancer Pain', 'Palliative care'], 'conditions': ['Myofascial Pain Syndromes', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '38484328', 'type': 'DERIVED', 'citation': 'Santos-Vilar LAD, Freitas-Passos IF, Rossi BM, Blauth FG, Pontes VCB, Moriguti JC, Riberto M, Lima NKDC. Lidocaine Needling in Myofascial Pain Syndrome for Palliative Oncologic Care: A Randomized Clinical Study. J Palliat Med. 2024 Jul;27(7):888-894. doi: 10.1089/jpm.2023.0641. Epub 2024 Mar 14.'}], 'seeAlsoLinks': [{'url': 'http://fmrp.usp.br', 'label': 'Webpage of the Ribeirão Preto Medical School'}]}, 'descriptionModule': {'briefSummary': 'Palliative Care is active holistic care offered to people who are in intense suffering related to their health, resulting from a serious life-threatening illness, with a focus on improving the quality of life. Among the symptoms that cause suffering, physical pain has a prominent role in terms of prevalence and impact on well-being, especially in the subgroup of patients with terminal cancer. Myofascial Pain Syndrome may be one of the components of pain in cancer patients in palliative care. However, the literature is scarce in defining the prevalence of this condition in this population, and there is no evidence of the benefit of needling treatment with 1% lidocaine in these patients until now. The objectives of this study are to determinate the prevalence of myofascial pain syndrome and to evaluate the effectiveness of myofascial pain treatment with 1% lidocaine injection in reducing pain in palliative cancer patients, comparing it with a control group in usual care.', 'detailedDescription': "This is a clinical trial designed as a comparative, randomized, single-blinded intervention study. Patients will be recruited from wards and radiotherapy sector of the Ribeirão Preto Clinical Hospital - Ribeirão Preto Medical School, University of São Paulo (FMRP-USP). Initially, patients aged 50 years or older with cancer in palliative care will be evaluated to assess the prevalence of myofascial pain syndrome using Travel and Simons' diagnostic criteria and for the following variables: demographic characteristics, functional status (Palliative Performance Scale), pain intensity (visual analog scale and pain threshold measurement with a pressure gauge), prognostic score (Palliative Prognosis Score), depression and anxiety (Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 PAL) and analgesic drugs in use. The participants that (1) accomplish the Travel and Simons' diagnostic criteria for myofascial pain syndrome, (2) have performance status on the Karnofsky scale of 30 or more, and (3) have pain intensity on visual analog scale of 5 or more will be randomized for the clinical trial. The sample size calculation resulted in 15 participants for each group, totaling a sample composed of 30 patients. The intervention group will be submitted to the trigger point injection procedure with 1% lidocaine, and the control group will receive usual care, defined as the treatment for pain prescribed by their assistant doctors. Both groups will be reevaluated after 72 hours and 1 week after the procedure. In the analysis statistics, chi-square test (or Fisher's exact test) will be used to evaluate categorical variables. For the comparison between the groups at each moment (before and after intervention) will be used the linear mixed effects model. The significance level established was \\<0.05. SAS Statistical Software (version 9.3; SAS Institute, Inc. Cary , NC) will be used for the analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants that\n\n 1. accomplish the Travel and Simons' diagnostic criteria for myofascial pain syndrome,\n 2. have pain intensity on visual analog scale of 5 or more,\n 3. have performance status on the Karnofsky Performance Status scale of 30 or more.\n\nExclusion Criteria:\n\n* Use of high dose anticoagulants (RNI above the therapeutic range);\n* Patients with hemorrhagic diathesis;\n* Patients with moderate to severe dementia syndrome;\n* Patients with diagnosis of acute confusional state during the follow-up;\n* Occurrence of clinical complication or intervention that could compromise the reevaluation of pain in the following days (for example, undergoing a surgical procedure or nerve block) or death."}, 'identificationModule': {'nctId': 'NCT04703803', 'briefTitle': 'Efficacy of Myofascial Pain Syndrome Treatment in Patients With Cancer in Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Treatment of Myofascial Pain Syndrome With Lidocaine Injection in Patients With Cancer in Palliative Care: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MPS_palliativecancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1% lidocaine injection', 'description': 'The intervention group will be submitted to the trigger point injection procedure with 1% lidocaine (the sum of all needled trigger points will have a maximum of 10 ml), in a single intervention', 'interventionNames': ['Combination Product: 1% lidocaine injection in trigger points']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group will receive usual care, defined as the treatment for pain prescribed by their assistant doctors.'}], 'interventions': [{'name': '1% lidocaine injection in trigger points', 'type': 'COMBINATION_PRODUCT', 'description': 'The trigger point injection procedure with 1% lidocaine will be e (the sum of all needled trigger points will have a maximum of 10 ml), in a single intervention', 'armGroupLabels': ['1% lidocaine injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Laís Araujo Dos Santos Vilar', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After the publication of results of study', 'ipdSharing': 'YES', 'description': 'IPD to be made available after the end of the study protocol', 'accessCriteria': 'Researchers after the review and approval of protocol by the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nereida Kilza da Costa Lima', 'investigatorAffiliation': 'University of Sao Paulo'}}}}