Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-02 @ 4:10 AM
Study NCT ID:
NCT05682235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-17
First Post:
2022-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'the participants will not know in which treatment group they are, and the investigator in charge of carrying out the evaluation will not know to which group the subjects he evaluates belong to.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Through a randomization program, participants will be assigned to the treatment group or the control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2022-12-26', 'studyFirstSubmitQcDate': '2022-12-26', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline, Up to 1 month, Up to 3 months', 'description': 'The scale will be administered by one of the researchers. Minimum value 0. Maximum value 100. Higher score = Higher level of pain. Lowe and lower scores mean a better result.'}], 'secondaryOutcomes': [{'measure': 'Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)', 'timeFrame': 'Baseline, Up to 1 month, Up to 3 months', 'description': 'The scale will be administered by one of the researchers. Minimum value 11. Maximum value 44. Higher score = Higher level of kinesiophobia. Lower and lower scores mean better results.'}, {'measure': 'Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)', 'timeFrame': 'Baseline, Up to 1 month, Up to 3 months', 'description': 'The scale will be administered by one of the researchers. Minimum value 0. Maximum value 52. Higher score = Higher level of catastrophism. Lower and lower scores mean better results.'}, {'measure': 'Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)', 'timeFrame': 'Up to 6 months', 'description': 'The scale will be administered by one of the researchers. Minimum value -7. Maximum value 7. Higher score = Increased improvement with treatment. Lower scores = 45 / 5.000 Resultados de traducción Resultado de traducción worsening of the patient with treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Quality of life', 'Chronic pelvic pain', 'therapeutic exercise', 'pain neurophysiology', 'physiotherapy'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to improve pain intensity.', 'detailedDescription': 'A study will be carried out whose objective is to improve the intensity of pain in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: kinesiophobia, catastrophism and impression of global improvement with treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of reproductive age between 18 and 45 years.\n* Women with a medical diagnosis of endometriosis.\n* Women with visual analog scale (EVA) between 4 and 10 (moderate-severe pain) during the last 3 months in the suprapubic area, abdomen or perineum both continuously and intermittently.\n\nExclusion Criteria:\n\n* Women who must have surgery during the study.\n* Women who have undergone abdominal or pelvic surgery or who have given birth (vaginal or cesarean) in the last 6 months.\n* Women who are pregnant or planning a pregnancy.\n* Women with uncorrected pacemakers or coagulopathies, severe comorbid disorder, cancer (in the last 5 years or at present), severe mental disorders, or neuropathies affecting the nerves of the pelvis or lower extremities.\n* Physiotherapy treatments or treatments related to pathology or study areas 15 days prior to the beginning of the study.\n* Variations in medication in the 3 months prior to the start of the study.'}, 'identificationModule': {'nctId': 'NCT05682235', 'briefTitle': 'Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Valladolid'}, 'officialTitle': 'Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.', 'orgStudyIdInfo': {'id': 'Endometriosis2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Exercise AND Pain Neurophysiology Education', 'description': 'Therapeutic exercise:\n\nTherapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, prevent risk factors for solid and optimize overall health status.\n\nPain Neurophysiology Education:\n\nEducation in pain neurophysiology consists in describing to the patient the neurobiology and neurophysiology of his nervous system pain to improve the processing of it and diminish the threatening meaning of pain.', 'interventionNames': ['Other: Therapeutic exercise AND pain neurophysiology education']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Comparator', 'description': 'Talks about healthy habits', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'Therapeutic exercise AND pain neurophysiology education', 'type': 'OTHER', 'description': 'A program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group and talks on healthy habits to the placebo group participants.', 'armGroupLabels': ['Therapeutic Exercise AND Pain Neurophysiology Education']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'Talk about healthy habits', 'armGroupLabels': ['Sham Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47002', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'University of Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Sandra Jímenez, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Valladolid'}, {'name': 'Luis Ceballos Laita, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Valladolid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data of the participants will only be kept by the study researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valladolid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctorate Student', 'investigatorFullName': 'Rebeca Abril Coello', 'investigatorAffiliation': 'University of Valladolid'}}}}