Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 7:19 PM
Study NCT ID:
NCT04328805
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2020-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059350', 'term': 'Chronic 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': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2020-03-29', 'studyFirstSubmitQcDate': '2020-03-29', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distal upper limb pain', 'timeFrame': 'Changes from baseline (measured immediately before the application of the first treatment) and 60 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 100-mm 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 millimeters from 0 (no pain) to the patient's marked rating."}], 'secondaryOutcomes': [{'measure': 'Upper limb function', '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': 'Assessed through the quick Quick Disabilities of the Arm, Shoulder and Hand questionary (QuickDASH), which is a shortened version of the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) 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).'}, {'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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome', 'Ibuprofen', 'Pain Management', 'Pain, Chronic']}, 'referencesModule': {'references': [{'pmid': '30810754', 'type': 'BACKGROUND', 'citation': 'Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.'}, {'pmid': '30502019', 'type': 'BACKGROUND', 'citation': 'Weinheimer K, Michelotti B, Silver J, Taylor K, Payatakes A. A Prospective, Randomized, Double-Blinded Controlled Trial Comparing Ibuprofen and Acetaminophen Versus Hydrocodone and Acetaminophen for Soft Tissue Hand Procedures. J Hand Surg Am. 2019 May;44(5):387-393. doi: 10.1016/j.jhsa.2018.10.014. Epub 2018 Nov 27.'}, {'pmid': '28316723', 'type': 'BACKGROUND', 'citation': 'Riasi H, Rajabpour Sanati A, Salehi F, Salehian H, Ghaemi K. Analyzing the therapeutic effects of short wrist splint in patients with carpal tunnel syndrome (CTS) under ibuprofen treatment from an EMG-NCV perspective. J Med Life. 2015;8(Spec Iss 4):154-158.'}, {'pmid': '26433799', 'type': 'BACKGROUND', 'citation': 'Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29.'}, {'pmid': '9627862', 'type': 'BACKGROUND', 'citation': 'Davis PT, Hulbert JR, Kassak KM, Meyer JJ. Comparative efficacy of conservative medical and chiropractic treatments for carpal tunnel syndrome: a randomized clinical trail. J Manipulative Physiol Ther. 1998 Jun;21(5):317-26.'}, {'pmid': '26327799', 'type': 'BACKGROUND', 'citation': 'Giuliani E, Bianchi A, Marcuzzi A, Landi A, Barbieri A. Ibuprofen timing for hand surgery in ambulatory care. Acta Ortop Bras. 2015 Jul-Aug;23(4):188-91. doi: 10.1590/1413-78522015230400736.'}, {'pmid': '8176515', 'type': 'BACKGROUND', 'citation': 'Banta CA. A prospective, nonrandomized study of iontophoresis, wrist splinting, and antiinflammatory medication in the treatment of early-mild carpal tunnel syndrome. J Occup Med. 1994 Feb;36(2):166-8. doi: 10.1097/00043764-199402000-00012.'}, {'pmid': '28731977', 'type': 'BACKGROUND', 'citation': 'Dosenovic S, Jelicic Kadic A, Miljanovic M, Biocic M, Boric K, Cavar M, Markovina N, Vucic K, Puljak L. Interventions for Neuropathic Pain: An Overview of Systematic Reviews. Anesth Analg. 2017 Aug;125(2):643-652. doi: 10.1213/ANE.0000000000001998.'}, {'pmid': '29559834', 'type': 'BACKGROUND', 'citation': 'Calvo-Lobo C, Unda-Solano F, Lopez-Lopez D, Sanz-Corbalan I, Romero-Morales C, Palomo-Lopez P, Seco-Calvo J, Rodriguez-Sanz D. Is pharmacologic treatment better than neural mobilization for cervicobrachial pain? A randomized clinical trial. Int J Med Sci. 2018 Mar 8;15(5):456-465. doi: 10.7150/ijms.23525. eCollection 2018.'}, {'pmid': '28734105', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Sanz D, Lopez-Lopez D, Unda-Solano F, Romero-Morales C, Sanz-Corbalan I, Beltran-Alacreu H, Calvo-Lobo C. Effects of Median Nerve Neural Mobilization in Treating Cervicobrachial Pain: A Randomized Waiting List-Controlled Clinical Trial. Pain Pract. 2018 Apr;18(4):431-442. doi: 10.1111/papr.12614. Epub 2017 Nov 20.'}, {'pmid': '29521045', 'type': 'BACKGROUND', 'citation': 'Eren Y, Yavasoglu NG, Comoglu SS. The relationship between QDASH scale and clinical, electrophysiological findings in carpal tunnel syndrome. Adv Clin Exp Med. 2018 Jan;27(1):71-75. doi: 10.17219/acem/67947.'}, {'pmid': '28115830', 'type': 'BACKGROUND', 'citation': 'Shin D, Lee SJ, Ha YM, Choi YS, Kim JW, Park SR, Park MK. Pharmacokinetic and pharmacodynamic evaluation according to absorption differences in three formulations of ibuprofen. Drug Des Devel Ther. 2017 Jan 4;11:135-141. doi: 10.2147/DDDT.S121633. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'In the present investigation, the pain reduction effect of median nerve neural mobilization and oral ibuprofen treatments will be compared to those produced by the absence of 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 median nerve neural mobilization and oral ibuprofen treatments to the total lack of treatment in subjects diagnosed with carpal tunnel syndrome. Effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 3 different groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, '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.\n* The presence of cognitive impairment.\n* Tumors.\n* Cancer.\n* Upper limb surgery or trauma.\n* Pregnancy.\n* Deformities of the (affected) upper limb.\n* Recent skin injuries or infections (in the affected upper limb).\n* Autoimmune inflammatory conditions or flu type symptoms.\n* Allergy (or contraindication) to non steroidal anti inflammatory drugs (NSAID)\n* Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).\n* Metabolic neuropathy.\n* Obesity (body mass index over 30).\n* Participants who are not employed.'}, 'identificationModule': {'nctId': 'NCT04328805', 'briefTitle': 'Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Pain Reduction and Changes in Upper Limb Function Produced by Over the Counter Oral Ibuprofen and Median Nerve Neural Mobilization Versus the Lack of Treatment, in Carpal Tunnel Syndrome.', 'orgStudyIdInfo': {'id': 'CE0072015-02-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'description': 'Oral tablet 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 4 weeks.', 'interventionNames': ['Drug: ibuprofen tablets']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Waiting list control group. Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available.'}, {'type': 'EXPERIMENTAL', 'label': 'Median nerve neural mobilization', 'description': 'Median nerve neural mobilization non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks.', 'interventionNames': ['Other: Median nerve neural mobilization']}], 'interventions': [{'name': 'ibuprofen tablets', 'type': 'DRUG', 'otherNames': ['Advil'], 'description': 'oral tablet', 'armGroupLabels': ['Ibuprofen']}, {'name': 'Median nerve neural mobilization', 'type': 'OTHER', 'description': 'Manual therapy maneuver performed in the upper limb', 'armGroupLabels': ['Median nerve neural mobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02001', 'city': 'Valencia', 'state': 'Carabobo', 'country': 'Venezuela', 'facility': 'Ciudad Hospitalaria Enrique Tejera', 'geoPoint': {'lat': 10.16153, 'lon': -68.00044}}], 'overallOfficials': [{'name': 'Carlos Perez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'INSALUD'}]}, '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'}}}}