Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT07146620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Radial Nerve Mobilization for Chronic Epicondylalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009068', 'term': 'Movement'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D010829', 'term': 'Physiological Phenomena'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatment protocol based on massage therapy, pressure release of myofascial trigger points, manual mobilization technique (Mulligan), and Diacutaneous Fibrolysis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'From enrollment to the end of treatment (4 weeks), and to the end of the study at 16 weeks.', 'description': 'Numeric Pain Rating Scale. Score from 0 to 10. Zero is equivalent to no pain and 10 indicates the worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Pain and Functional Disability', 'timeFrame': 'From enrollment to the end of treatment (4 weeks), and to the end of the study at 16 weeks.', 'description': 'Patient-Rated Tennis Elbow Evaluation. Score from 0 to 100. Higher score indicates more pain and functional disability and zero indicates no pain and disability.'}, {'measure': 'Handgrip', 'timeFrame': 'From enrollment to the end of treatment (4 weeks), and to the end of the study at 16 weeks.', 'description': 'Grip strength is assessed in kilograms. The value used is the average of three repetitions.'}, {'measure': 'Pressure pain threshold - Elbow', 'timeFrame': 'From enrollment to the end of treatment (4 weeks), and to the end of the study at 16 weeks.', 'description': 'Pressure pain threshold at the elbow. The lowest intensity of pressure that the subject perceives as pain when applied to the lateral epicondyle is recorded. The value used will be in kilograms per square centimeter.'}, {'measure': 'Pressure pain threshold - short radial extensor', 'timeFrame': 'From enrollment to the end of treatment (4 weeks), and to the end of the study at 16 weeks.', 'description': 'Pressure pain threshold at the Short radial extensor.The lowest intensity of pressure that the subject perceives as pain when applied to the short radial extensor is used. The value used will be in kilograms per square centimeter.'}, {'measure': 'Pressure pain threshold - Radial nerve', 'timeFrame': 'From enrollment to the end of treatment (4 weeks), and to the end of the study at 16 weeks.', 'description': 'Pressure pain threshold at the radial nerve. It is used to record the lowest intensity of pressure that the subject perceives as pain when applied to the radial nerve tunnel. The value used will be in kilograms per square centimeter.'}, {'measure': 'Central sensitization syndrome', 'timeFrame': 'From enrollment to the end of treatment (4 weeks), and to the end of the study at 16 weeks.', 'description': 'Central Sensitization Inventory. The questionnaire is scored on a scale from 0 to 100. A score above 40 is considered to indicate central sensitization.'}, {'measure': 'Subjective perception of clinical evolution', 'timeFrame': 'From the 4 week to the end of study at 16 weeks', 'description': 'Global Rating of Change scale. The scale consists of 15 points, ranging from -7 ("Much worse") to +7 ("Much better"). For clinical interpretation, values below "Somewhat better" or "Somewhat worse" are considered clinically unchanged. Values greater than or equal to "Somewhat better" are considered clinically improved, and values greater than "Somewhat worse" are considered clinically worsened.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tennis Elbow', 'Physical Therapy Modalities']}, 'descriptionModule': {'briefSummary': 'Effectiveness of radial nerve mobilization techniques and their interfaces for treating chronic epicondylalgia\n\nIntervention: This is a randomized controlled clinical trial that will evaluate the effectiveness of adding radial nerve and its interface mobilization techniques to conventional musculoskeletal treatment.\n\nParticipants: Patients over 18 years of age with a diagnosis of chronic epicondylalgia and a positive radial nerve neurodynamic test. Those with previous infiltrations, concomitant pathologies, or contraindications will be excluded.\n\nStudy Groups:\n\n* Control Group (n=23): Will receive conventional musculoskeletal treatment.\n* Intervention Group (n=23): Will receive the same conventional treatment plus mobilization of the radial nerve and its interfaces.\n\nPrimary Outcomes:\n\n* Pain (NPRS).\n* Pain and functionality (PRTEE).\n* Pressure pain threshold (Algometry).\n* Pain-free grip strength (Dynamometry).\n* Central sensitization (CSI). Assessments will be conducted at baseline, one week after the last treatment, and 3 months after the last treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Over 18 years old.\n* Clinical diagnosis of lateral epicondylalgia.\n* Chronic epicondylalgia symptoms for at least 3 months.\n* Positive radial nerve neurodynamic test\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Infiltrations for CE within at least 3 months prior to the study.\n* Concomitant problems or mobility issues of the upper limb or cervical spine.\n* Contraindications specific to Diacutaneous Fibrolysis or neural mobilization.\n* Difficulty understanding and signing the informed consent form.'}, 'identificationModule': {'nctId': 'NCT07146620', 'briefTitle': 'Effectiveness of Radial Nerve Mobilization for Chronic Epicondylalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Effectiveness of Radial Nerve Mobilization Techniques and Their Interfaces for Treating Chronic Epicondylalgia', 'orgStudyIdInfo': {'id': 'CER: FIS-2021-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The subjects in this group will receive a physical therapy protocol based on massage therapy, pressure release of myofascial trigger points, manual mobilization technique (Mulligan), neurodynamic mobilization, and a real Diacutaneous Fibrolysis (instrument-assisted soft tissue mobilization). The intervention will be administered once per week for four weeks.', 'interventionNames': ['Other: Forearm massage', 'Other: Pressure release for forearm trigger points', 'Other: Mulligan mobilization with movement technique', 'Other: Diacutaneous fibrolysis (Real)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'The subjects in this group will receive a physical therapy protocol based on massage therapy, pressure release of myofascial trigger points, manual mobilization technique (Mulligan), and a Sham Diacutaneous Fibrolysis (instrument-assisted soft tissue mobilization). The intervention will be administered once per week for four weeks.', 'interventionNames': ['Other: Forearm massage', 'Other: Pressure release for forearm trigger points', 'Other: Mulligan mobilization with movement technique', 'Other: Radial Nerve Neurodynamic Mobilization', 'Other: Diacutaneous Fibrolysis (Sham)']}], 'interventions': [{'name': 'Forearm massage', 'type': 'OTHER', 'otherNames': ['Soft Tissue Mobilization of the Forearm'], 'description': 'A general massage of the forearm will be performed. The physical therapist perform deep, longitudinal strokes. Pressure will be maintained at a level the patient finds comfortable for 3 minutes.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Pressure release for forearm trigger points', 'type': 'OTHER', 'otherNames': ['Trigger point therapy for the forearm', 'Ischemic compression of forearm trigger point'], 'description': 'Pressure will be applied to trigger points in the forearm. This will be done in three sets of 30-second applications, with 30 seconds of rest between each.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Mulligan mobilization with movement technique', 'type': 'OTHER', 'otherNames': ['Mobilization with Movement (MWM)'], 'description': 'A lateromedial glide will be performed. The technique will be applied for three sets of 10 repetitions, with 30 seconds of rest between each set.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Radial Nerve Neurodynamic Mobilization', 'type': 'OTHER', 'otherNames': ['Radial Nerve Glides'], 'description': 'Three sets of 30 nerve glides will be performed at a rhythm of one second of tension followed by one second of rest. There will be 30 seconds of rest between sets.', 'armGroupLabels': ['Control Group']}, {'name': 'Diacutaneous fibrolysis (Real)', 'type': 'OTHER', 'otherNames': ['Diacutaneous fibrolysis'], 'description': 'A real technique of Diacutaneous fibrolysis will be applied to the forearm region for 5 minutes.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Diacutaneous Fibrolysis (Sham)', 'type': 'OTHER', 'description': 'A sham Diacutaneous Fibrolysis technique (skin pinch) will be applied to the forearm region for 5 minutes.', 'armGroupLabels': ['Control Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer Professor', 'investigatorFullName': 'Carlos López de Celis', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}