Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 1:50 PM
Study NCT ID:
NCT06778759
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibuprofen Arginine and Neural Mobilization Versus Ibuprofen Arginine in the Treatment of Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106674', 'term': 'ibuprofen arginine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-01-12', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Work Status at baseline', 'timeFrame': 'Measured immediately before the application of the first treatment', 'description': 'This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"'}, {'measure': 'Work Status post treatment', 'timeFrame': 'Measured immediatly after the application of the last treatment.', 'description': 'This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Do you currently work?"'}, {'measure': 'Change in Work Task (Job Type)', 'timeFrame': 'Measured immediatly after the application of the last treatment.', 'description': 'This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: "Did you change your job type or task?"'}, {'measure': 'Tampa Scale for Kinesiophobia-17 (TSK-17', 'timeFrame': 'Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment.', 'description': 'The Tampa Scale for Kinesiophobia-17 (TSK-17) is a 17-item questionnaire designed to assess the fear of movement and re-injury (kinesiophobia). Items are rated on a 4-point Likert scale (ranging from "strongly disagree" to "strongly agree"), yielding a total score that reflects the severity of pain-related fear avoidance beliefs. It\'s a widely used and vailidaded clinical and research instrument. The standard total score range for the Tampa Scale for Kinesiophobia (TSK-17) is 17 to 68. It is calculated by summing 17 items, each scored 1-4, with four items reverse-scored. Higher scores indicate greater fear of movement.'}], 'primaryOutcomes': [{'measure': 'Distal upper limb pain', 'timeFrame': 'Through study completion, an average of 2 weeks. Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment', 'description': "Assessed through the visual analog scale (VAS). The VAS is a psychometric response scale. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The VAS is the most frequently used method to assess pain intensity. The scale will be displayed as a horizontal 10-cm line labelled at each end by descriptors such as 'no pain' (the minimum and best outcome possible) and 'worse pain ever' (maximum and worst outcome possible). The participant will mark the line to indicate pain severity and it is simply quantified by measuring the distance in centimeters from 0 (no pain) to the patient's marked rating."}], 'secondaryOutcomes': [{'measure': 'Upper limb function', 'timeFrame': 'Through study completion, an average of 2 weeks. Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment.', 'description': 'Assessed through the QuickDASH questionary, which is a shortened version of the 30-item DASH (Disabilities of the Arm, Shoulder and Hand) instrument.The instrument administered to the participants will be a self-report questionnaire, that will rate the difficulty and interference of daily life on a 5 point Likert scale. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ibuprofen arginine', 'Median nerve neural mobilization', 'Pain'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical ibuprofen arginine treatment will be compared to those produced by ibuprofen (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.', 'detailedDescription': 'The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral ibuprofen arginine treatment, to those effects produced by a ibuprofen arginine (only) treatment. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).\n* Full understanding of written and spoken Spanish (language).\n* Participants must freely consent to participate.\n* The presence of positive Phalen and Tinel signs.\n* The presence of carpal tunnel syndrome signs and symptoms\n\nExclusion Criteria:\n\n* The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive)'}, 'identificationModule': {'nctId': 'NCT06778759', 'briefTitle': 'Ibuprofen Arginine and Neural Mobilization Versus Ibuprofen Arginine in the Treatment of Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Pain Reduction Effect of a Combined Oral Ibuprofen Arginine and Neural Mobilization Treatment Versus an (Only) Oral Ibuprofen Arginine Treatment in Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'CE0072015-02-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Median nerve neural mobilization and oral ibuprofen arginine', 'description': 'Median nerve neural mobilization, non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induce median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 2 weeks. This arm will also receive an oral ibuprofen arginine pharmaceutical treatment. Participants will be treated with a maximum of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 2 weeks', 'interventionNames': ['Combination Product: median nerve neural mobilization combined with oral ibuprofen arginine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen arginine', 'description': 'Participants will be treated with a maximum of 1200 mg of oral ibuprofen arginine tablets per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 2 weeks', 'interventionNames': ['Drug: Ibuprofen Arginine']}], 'interventions': [{'name': 'median nerve neural mobilization combined with oral ibuprofen arginine', 'type': 'COMBINATION_PRODUCT', 'description': 'Manual therapy maneuver performed in the upper limb combined with ibuprofen arginine oral tablets', 'armGroupLabels': ['Median nerve neural mobilization and oral ibuprofen arginine']}, {'name': 'Ibuprofen Arginine', 'type': 'DRUG', 'otherNames': ['Spedifen'], 'description': 'Ibuprofen arginine oral tablets', 'armGroupLabels': ['Ibuprofen arginine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02001', 'city': 'Valencia', 'state': 'Carabobo', 'country': 'Venezuela', 'facility': 'Ciudad Hospitalaria Enrique Tejera', 'geoPoint': {'lat': 10.16153, 'lon': -68.00044}}], 'overallOfficials': [{'name': 'Francisco Unda, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Biomedicine Doctorate Program Investigator', 'investigatorFullName': 'Francisco Unda Solano', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}