Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 12:32 PM
Study NCT ID:
NCT04232358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2020-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training and Injection Treatment for Achilles Enthesopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-27', 'size': 459698, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-12T11:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2020-01-12', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)', 'timeFrame': '6 months', 'description': 'VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)', 'timeFrame': '3, 9 and 12 months', 'description': 'VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome'}, {'measure': 'Evaluation of treatment effect measured on a Likert scale.', 'timeFrame': '1, 2, 3, 6, 9 and 12 months', 'description': 'The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is cured and -5 is much worsened, 0 is the status when entering the study'}, {'measure': 'Ultrasonographic measurement of achilles tendon thickness', 'timeFrame': '1, 2, 3, 6, 9 and 12 months', 'description': 'Ultrasonographic measurement of achilles tendon thickness in mm is measured relative to the baseline values'}, {'measure': 'Patient self reported activity level in percentage of the pre-injury activity level', 'timeFrame': '3, 6 and 12 months', 'description': 'Self reported activity in percentage of the pre-injury activity level'}, {'measure': 'Ultrasonographic measurement of achilles tendon doppler activity', 'timeFrame': '1, 2, 3, 6, 9 and 12 months', 'description': 'Ultrasonographic measurement of achilles tendon doppler activity is measured (grade I-III) relative to the baseline values'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achilles Entesopathy']}, 'descriptionModule': {'briefSummary': 'Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies.\n\nThe purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.\n\n50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.', 'detailedDescription': 'Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Symptoms are pain and swelling at the calcaneal insertion of the achilles tendon during and after exercise. Achilles entesopathy has not been thoroughly investigated and consequently, very little is known regarding the effect of different treatment strategies.\n\nThe purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.\n\nIt is hypothesized that treatment that includes corticosteroid injection is more effective than treatment that includes injection with local anaesthesia.\n\n50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pain from the achilles tendon insertion/heel for at least 3 months\n* Achilles entesopathy verified by ultrasound\n* Between 18 and 65 years of age\n\nExclusion criteria:\n\n* Prior surgery in the leg with the exception of knee arthroscopy\n* Known medial conditions including diabetes or rheumatologic diseases\n* Taking pain medication regularly\n* Injection therapy for treatment of achilles entesopathy within the last 6 months'}, 'identificationModule': {'nctId': 'NCT04232358', 'briefTitle': 'Resistance Training and Injection Treatment for Achilles Enthesopathy', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as Treatment for Achilles Enthesopathy', 'orgStudyIdInfo': {'id': 'H-19041374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corticosteroid injections + resistance training', 'description': 'Corticosteroid injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months', 'interventionNames': ['Drug: Corticosteroid injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Local anesthesia injections + resistance training', 'description': 'Local anesthesia injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months', 'interventionNames': ['Drug: Local anesthesia injections']}], 'interventions': [{'name': 'Corticosteroid injection', 'type': 'DRUG', 'description': 'Corticosteroid injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.', 'armGroupLabels': ['Corticosteroid injections + resistance training']}, {'name': 'Local anesthesia injections', 'type': 'DRUG', 'description': 'Local anesthesia injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.', 'armGroupLabels': ['Local anesthesia injections + resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Surgeon', 'investigatorFullName': 'Simon Doessing, M.D., PhD', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}