Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-26 @ 6:26 PM
Study NCT ID:
NCT06816056
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy in Hemophilic Arthropathy of the Ankle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline hemarthrosis after treatment and at four weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline pressure pain threshold after treatment and at four weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Using a pressure algometer (model Wagner FPN100) we will measure the pain threshold to pressure, at the level of the joint and at a distance (in another part of the body). This device measures in Newton/cm2 the pressure at which the subject perceives pain under pressure. Pressure will be applied to the chosen point, which will be increased at a rate of approximately 50 kPa/s until the patient informs us that the sensation is starting to become painful. The lateral and medial malleoli of the ankle will be evaluated'}, {'measure': 'Change from baseline joint status after treatment and at four weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Change from knee and ankle joint status during treatment and follow-up period at four weeks. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).'}, {'measure': 'Change from baseline range of motion after treatment and at four weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Change from range of movement of ankle during treatment and follow-up period at four weeks. The range of motion of the ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by the American Academy of Orthopaedic Surgeons'}, {'measure': 'Change from baseline joint pain after treatment and at four weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Change in ankle intensity during treatment and the four-week follow-up period. Ankle joint pain intensity will be measured using the visual analogue scale with a range of 0 to 10 points, where the higher the score, the greater the perception of joint pain'}, {'measure': 'Change from baseline functional capacity after treatment and at four weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Change in functional capacity during treatment and the four-week follow-up period. Functional capacity will be measured using the 2-Minutes Walking Test. The maximum distance that patients can cover in a period of six minutes walking as fast as possible will be measured. The unit of measurement is the metre, where the greater the distance, the better the functional capacity.'}, {'measure': 'Change from baseline kinesiophobia after treatment and at four weeks', 'timeFrame': 'Screening visit, within the first seven days after treatment and after four weeks follow-up visit', 'description': 'Change in kinesiophobia during treatment and the four-week follow-up period. Fear of movement will be measured using the Tampa scale, which consists of 11 items on a 4-point Likert scale, with responses ranging from 1 (strongly disagree) to 4 (strongly agree). The lowest possible score, 11, denotes insignificant or non-existent kinesiophobia. The highest possible score, 44, denotes a severe fear of feeling pain when moving'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemophilic arthropathy', 'Ankle', 'Manual therapy', 'Joint pain'], 'conditions': ['Hemophilia A']}, 'descriptionModule': {'briefSummary': 'Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy.\n\nMethods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia.\n\nExpected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with haemophilia A and B\n* With severe haemophilia phenotype (\\<1% FVIII/FIX)\n* Over 18 years of age\n* With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score\n* On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates\n\nExclusion Criteria:\n\n* Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests\n* Failure to sign the informed consent document'}, 'identificationModule': {'nctId': 'NCT06816056', 'briefTitle': 'Manual Therapy in Hemophilic Arthropathy of the Ankle', 'organization': {'class': 'NETWORK', 'fullName': 'Investigación en Hemofilia y Fisioterapia'}, 'officialTitle': 'Safety and Efficacy of Manual Therapy in the Treatment of Haemophilic Arthropathy of the Ankle. A Randomised Multicentre Clinical Trial', 'orgStudyIdInfo': {'id': 'HE-ANKLEran'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'The intervention will last 3 weeks, with a periodicity of 1 weekly sessions. In total there will be 3 sessions lasting 50 minutes.\n\nThe techniques will be: global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding traction technique and triceps surae induction technique', 'interventionNames': ['Other: Manual Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The patients included in the control group will receive the same physiotherapy intervention in the form of a placebo. The physiotherapist in charge of this intervention will perform the same number of techniques but without applying sliding stimuli, myofascial induction or manipulation. The hands will be positioned in the same way and the times per technique will be the same as in the techniques of the experimental group.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Manual Therapy', 'type': 'OTHER', 'description': 'The patients included in the experimental group will receive a 50-minute physiotherapy intervention involving global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding and triceps surae induction techniques', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': "The patients included in the control group will receive a 50-minute physiotherapy intervention in which the physiotherapist's hands and the times per technique will be the same as in the experimental group, but without applying any sliding, mobilisation or manipulation", 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'CONTACT'}], 'facility': 'Universidad Católica San Antonio', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'CONTACT', 'email': 'cuestaruben@uniovi.es', 'phone': '607547274'}], 'overallOfficials': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Oviedo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Investigación en Hemofilia y Fisioterapia', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rubén Cuesta-Barriuso', 'investigatorAffiliation': 'Investigación en Hemofilia y Fisioterapia'}}}}