Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-05 @ 12:47 AM
Study NCT ID:
NCT05279794
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2022-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '20 minutes', 'description': 'Measured with Numeric Rating Scale wich consist in measure pain intensity with a score of 0-10'}, {'measure': 'Pression algometer', 'timeFrame': '20 minutes', 'description': 'Measures pressure pain thresholds'}], 'secondaryOutcomes': [{'measure': 'Spinal test', 'timeFrame': '20 minutes', 'description': 'Measured with Baiobit Software. The range of movement will be measured in grades as per: flexion/extension; right/left rotation; and right/left inclination'}, {'measure': 'Countermovement jump test', 'timeFrame': '20 minutes', 'description': 'Measured with Baiobit software counter movement jump test wich consist a velocity, height and accuracy evaluation of a vertical jump'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physiotherapy', 'Rehabilitation', 'Treatment', 'Active Trigger Point'], 'conditions': ['Low Back Pain', 'Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'Non-specific low back pain can be caused by the presence of active trigger points in the muscles of the lumbopelvic region. Trigger points are defined as hypersensitive points within a taut band of a musculoskeletal system that cause pain during contraction, stretching, or stimulation of said muscle. If these points are active, they can trigger referred pain, local tenderness, and vegetative responses. There is scientific evidence of the improvement of the treatment of these points through non-invasive manual techniques. The objective of this study will be to determine the effect of Strain Counterstrain and Myofascial Induction techniques in subjects with low back pain secondary to the presence of active trigger points in the lumbopelvic region. Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Strain Counterstrain technique and Myofascial Induction in participants with the presence of an active trigger point in the erector spinae muscle.', 'detailedDescription': 'The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 2 experimental groups and a placebo group, of no-pain positioning. In addition to basic indices and scales of low back pain and disability caused by low back pain, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when representing reliable results in differences between techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of low back pain\n* Presence of active trigger point in the erector spinae as described by Lawrence H. Jones\n\nExclusion Criteria:\n\n* Participants who present dizziness, vertigo;\n* Previous or scheduled surgeries in the lumbar spine and/or lower extremities;\n* Suspicion of serious fractures or pathologies (tumor, inflammation, infection, rheumatological disorder, systemic disease, presence of fever);\n* Diagnosis of radiculopathy or neuropathy;\n* Structural deformity in the spine; spondyloarthropathy, disabling pain and physical disability;\n* Use of pain relievers or anti-inflammatory drugs in the last 48 hours;\n* Neurological or psychiatric disorder;\n* Presence or suspicion of pregnancy'}, 'identificationModule': {'nctId': 'NCT05279794', 'briefTitle': 'Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CE012207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jones Group (Strain Counterstrain)', 'description': 'Jones Group consist in 90 seconds in a ralease positioning of no pain in muscle acortation', 'interventionNames': ['Other: Jones Group (Strain Counterstrain)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Myofascial Induction Group', 'description': 'Myofascial Induction Group consist in 15 minutes of superficial and deep lumbar fascia maneuvers', 'interventionNames': ['Other: Myofascial Induction Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo Group only have to mantain no pain positioning for 3 minutes', 'interventionNames': ['Other: Placebo Group']}], 'interventions': [{'name': 'Jones Group (Strain Counterstrain)', 'type': 'OTHER', 'description': 'No pain positioning technique with diaphragmatic breathing', 'armGroupLabels': ['Jones Group (Strain Counterstrain)']}, {'name': 'Myofascial Induction Group', 'type': 'OTHER', 'description': 'Myofascial Induction technique on the lumbar fascia', 'armGroupLabels': ['Myofascial Induction Group']}, {'name': 'Placebo Group', 'type': 'OTHER', 'description': 'No pain positioning of participants', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Universidad Católica de Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Juan Martínez Fuentes', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}