Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT06739694
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroscience Education in Shoulder Pain: Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'catastrophizing', 'timeFrame': 'Baseline and 5 weeks.', 'description': 'Pain catastrophizing scale (PCS)'}], 'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Baseline and 5 weeks.', 'description': 'Reduction in pain intensity using the Shoulder Pain and Disability Index (SPADI)'}, {'measure': 'Disability', 'timeFrame': 'Baseline and five weeks.', 'description': 'Improving functionality using the Shoulder Pain and Disability Index (SPADI)'}], 'secondaryOutcomes': [{'measure': 'kinesiophobia', 'timeFrame': 'Baseline and 5 weeks.', 'description': 'Tampa Scale of Kinesiophobia (TSK11)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'manual therapy', 'shoulder pain', 'pain neuroscience education'], 'conditions': ['Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '30178503', 'type': 'BACKGROUND', 'citation': 'Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: The purpose of this study was to assess the efficacy of a pain neuroscience education programme applied to patients with shoulder pain.', 'detailedDescription': 'A randomised controlled trial was performed. Fifty-five patients satisfied eligibility criteria, agreed to participate, and were randomized into an experimental group (n = 27) or control group (n =28). A manual therapy and exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18-70 years of age.\n* History of shoulder pain of more than 3 months duration.\n* Presence of a painful arc\n* Medical diagnosis of shoulder pain with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test\n\nExclusion Criteria:\n\n* Diagnosis of fibromyalgia.\n* Pregnancy.\n* A history of traumatic onset of shoulder pain.\n* Other histories of shoulder injury.\n* Torn tendons.\n* Ligamentous laxity based on a positive Sulcus and apprehension tests.\n* Numbness or tingling in the upper extremity.\n* Previous shoulder or cervical spine surgery.\n* Systemic illness.\n* Corticosteroid injection on the shoulder within 1 year of the study.\n* Physical therapy 6 months before the study.'}, 'identificationModule': {'nctId': 'NCT06739694', 'briefTitle': 'Neuroscience Education in Shoulder Pain: Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de León'}, 'officialTitle': 'The Efficacy of a Pain Neuroscience Education Programme in Shoulder Pain: a Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'SALUD DOCTORADO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Participants will receive 4 sessions of PNE and 5 sessions of manual therapy and exercises.', 'interventionNames': ['Behavioral: PNE', 'Procedure: Manual therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants will receive 5 sessions of manual therapy and exercises.', 'interventionNames': ['Procedure: Manual therapy']}], 'interventions': [{'name': 'PNE', 'type': 'BEHAVIORAL', 'otherNames': ['Manual therapy', 'Exercise'], 'description': 'A manual therapy(Mulligan´s Mobilization with Movement) and 4 sessions of strenght exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).', 'armGroupLabels': ['Experimental group']}, {'name': 'Manual therapy', 'type': 'PROCEDURE', 'description': '5 sessions of Mulligan´s Mobilization with Movement and 4 sessions of strenght exercises', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24196', 'city': 'León', 'state': 'Spain', 'country': 'Spain', 'facility': 'Eva', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}], 'overallOfficials': [{'name': 'Eva Prado Robles', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de León'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual data will not be shared due to ethical and legal restrictions on the privacy of participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de León', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator and clinical Professor', 'investigatorFullName': 'Eva Prado Robles', 'investigatorAffiliation': 'Universidad de León'}}}}