Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT06383104
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2024-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007592', 'term': 'Joint 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': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline joint pain after treatment and at 4 weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'The intensity of knee and ankle pain shall be measured with the visual analogue scale. This instrument has an excellent test-retest reliability. This measurement scale consists of an unnumbered 10 cm line, where the patient is asked to indicate the perception of pain in the knee and ankle joints in the last week. The scale ranges from 0 to 10, where 0 indicates no pain at all and 10 indicates maximum perceived pain.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline functional capacity after treatment and at 4 weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Functionality of the lower limbs will be measured with the 2-Minute Walking Test. Functional capacity to exercise will be assessed by this modified version of the 6-minute version. This instrument has shown excellent test-retest reliability. This test will be performed in a closed corridor, with a length of 30 m delimited between cones. Subsequently, they shall be instructed to walk around the circuit around the cones as fast as possible, but without running, for 2 minutes. The distance covered at the end of the 2 minutes, in metres, shall be recorded by the assessor.'}, {'measure': 'Change from baseline functionality after treatment and at 4 weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': "The Timed Up and Go Functionality Test will assess basic mobility skills, strength, balance and agility. This instrument can help predict an individual's risk of falls and other adverse outcomes. This test has shown excellent intra-rater reliability. This test measures the time it takes a patient to get up from an armchair (without using the arms to get up), walk to a line on the floor 3 m away, turn around, and return to the chair and sit down. The unit of measurement is seconds"}, {'measure': 'Change from baseline joint pain after treatment and at 4 weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Fatigue will be assessed using the Fatigue Assessment Scale. This scale provides information on physical and psychological aspects of fatigue. The reliability of this scale is high. This instrument is a self-report questionnaire consisting of 10 items with a 5-point Likert response scale ranging from "1=never to "5=Always". Five items reflect the physical component and five reflect the psychological component. The score range of the scale is 10-50, where the higher the score, the greater the degree of fatigue.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic lupus erythematosus', 'Physiotherapy', 'Joint pain', 'Range of motion', 'Functionality', 'Balance', 'Fatigue'], 'conditions': ['System; Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.\n\nObjective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.\n\nMethods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.\n\nExpected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects over 18 years of age\n* With a medical diagnosis of systemic lupus erythematosus\n* Who sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with fever or acute phlebitis.\n* Patients with recent lower limb fractures\n* Amputees and people with neurological or cognitive impairments that prevent them from correctly understanding the questionnaires and performing the guided techniques.'}, 'identificationModule': {'nctId': 'NCT06383104', 'briefTitle': 'Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Combination of Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in the Clinical and Functional Improvement of Patients With Systemic Lupus Erythematosus. Randomised Clinical Study', 'orgStudyIdInfo': {'id': 'MyoLupus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.', 'interventionNames': ['Other: Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients included in the control group will not receive any intervention, maintaining their activities of daily living in the same way as before the study.'}], 'interventions': [{'name': 'Intervention', 'type': 'OTHER', 'description': 'Three myofascial release techniques will be performed with low load and long duration stretching to the myofascial complex to restore optimal length, decrease pain and improve function. In the development of the deep myofascial techniques, respiratory synchronisation with the patient will be performed. Proprioceptive neuromuscular facilitation techniques will be performed by executing diagonal spiral movements against resistance, several times, through a full range of motion. Three sets of three repetitions with 6-second contractions and a 30-second rest between sets shall be performed.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Universidad Católica San Antonio, Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rubén Cuesta-Barriuso, PhD', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}