Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01185951
Status:
UNKNOWN
Last Update Posted:
2010-08-20
First Post:
2010-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D000092462', 'term': 'Patella Fracture'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000092443', 'term': 'Knee Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077423', 'term': 'Polidocanol'}, {'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-19', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]', 'timeFrame': 'up to 4 years', 'description': 'Score of patient-related outcome measure: Achilles tendon: VISA-A \\[0=worse, 100=perfect\\] derived from eight validated questions on pain and function during activities of daily living'}, {'measure': 'Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect]', 'timeFrame': 'up to 4 years', 'description': 'Score of patient-related outcome measure: Patella tendon: VISA-P \\[0=worse, 100=perfect\\] derived from eight validated questions on pain and function during daily activities'}, {'measure': 'Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse]', 'timeFrame': 'up to four years', 'description': 'Score of patient-related outcome measure: Epicondylitis: DASH score \\[0=perfect, 100=worse\\] derived from 30 validated questions regarding the impairment in activities of daily living'}], 'secondaryOutcomes': [{'measure': 'Pain level at rest [VAS 0-10]', 'timeFrame': 'up to 4 years'}, {'measure': 'Pain level at exertion [VAS 0-10]', 'timeFrame': 'up to 4 years'}, {'measure': 'Patient satisfaction on Likert scale [1-6]', 'timeFrame': 'up to 4 years', 'description': 'Patient satisfaction on Likert scale from 1=perfect, wholy satisfied, to 6=worst, dissatisfied'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Achilles Tendon', 'Patella', 'Allergy', 'Necrosis', 'Infection'], 'conditions': ['Tendinopathy', 'Epicondylitis']}, 'referencesModule': {'references': [{'pmid': '19997901', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Schreibmueller L, Kraemer R, Jagodzinski M, Vogt PM, Redeker J. Gender and eccentric training in Achilles mid-portion tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2010 May;18(5):648-55. doi: 10.1007/s00167-009-1006-7. Epub 2009 Dec 9.'}, {'pmid': '19882141', 'type': 'BACKGROUND', 'citation': 'Osadnik R, Redeker J, Kraemer R, Vogt PM, Knobloch K. Microcirculatory effects of topical glyceryl trinitrate on the Achilles tendon microcirculation in patients with previous Achilles tendon rupture. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):977-81. doi: 10.1007/s00167-009-0958-y. Epub 2009 Oct 31.'}, {'pmid': '19567665', 'type': 'BACKGROUND', 'citation': 'Kraemer R, Knobloch K. A soccer-specific balance training program for hamstring muscle and patellar and achilles tendon injuries: an intervention study in premier league female soccer. Am J Sports Med. 2009 Jul;37(7):1384-93. doi: 10.1177/0363546509333012.'}, {'pmid': '18791700', 'type': 'BACKGROUND', 'citation': 'Knobloch K. Sclerosing polidocanol injections in Achilles tendinopathy in high level athletes. Knee Surg Sports Traumatol Arthrosc. 2008 Nov;16(11):1061-2; author reply 1063. doi: 10.1007/s00167-008-0613-z. Epub 2008 Sep 13. No abstract available.'}, {'pmid': '18785416', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Yoon U, Vogt PM. Acute and overuse injuries correlated to hours of training in master running athletes. Foot Ankle Int. 2008 Jul;29(7):671-6. doi: 10.3113/FAI.2008.0671.'}, {'pmid': '18720130', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Schreibmueller L, Longo UG, Vogt PM. Eccentric exercises for the management of tendinopathy of the main body of the Achilles tendon with or without an AirHeel Brace. A randomized controlled trial. B: Effects of compliance. Disabil Rehabil. 2008;30(20-22):1692-6. doi: 10.1080/09638280701785676.'}, {'pmid': '18720121', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Schreibmueller L, Longo UG, Vogt PM. Eccentric exercises for the management of tendinopathy of the main body of the Achilles tendon with or without the AirHeel Brace. A randomized controlled trial. A: effects on pain and microcirculation. Disabil Rehabil. 2008;30(20-22):1685-91. doi: 10.1080/09638280701786658.'}, {'pmid': '18681232', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Thermann H. [Achilles tendinopathy--modern evidence-based recommendations]. MMW Fortschr Med. 2008 Jun 26;150(26-27):46-9; quiz 50. No abstract available. German.'}, {'pmid': '18641371', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Grasemann R, Spies M, Vogt PM. Midportion achilles tendon microcirculation after intermittent combined cryotherapy and compression compared with cryotherapy alone: a randomized trial. Am J Sports Med. 2008 Nov;36(11):2128-38. doi: 10.1177/0363546508319313. Epub 2008 Jul 18.'}, {'pmid': '18447938', 'type': 'BACKGROUND', 'citation': 'Knobloch K. The role of tendon microcirculation in Achilles and patellar tendinopathy. J Orthop Surg Res. 2008 Apr 30;3:18. doi: 10.1186/1749-799X-3-18.'}, {'pmid': '17971505', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Schreibmueller L, Meller R, Busch KH, Spies M, Vogt PM. Superior Achilles tendon microcirculation in tendinopathy among symptomatic female versus male patients. Am J Sports Med. 2008 Mar;36(3):509-14. doi: 10.1177/0363546507309313. Epub 2007 Oct 30.'}, {'pmid': '17549956', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Kraemer R, Jagodzinski M, Zeichen J, Meller R, Vogt PM. Eccentric training decreases paratendon capillary blood flow and preserves paratendon oxygen saturation in chronic achilles tendinopathy. J Orthop Sports Phys Ther. 2007 May;37(5):269-76. doi: 10.2519/jospt.2007.2296.'}, {'pmid': '17496066', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Spies M, Busch KH, Vogt PM. Sclerosing therapy and eccentric training in flexor carpi radialis tendinopathy in a tennis player. Br J Sports Med. 2007 Dec;41(12):920-1. doi: 10.1136/bjsm.2007.036558. Epub 2007 May 11.'}, {'pmid': '17385103', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Thermann H, Hufner T. [Achilles tendon rupture--early functional and surgical options with special emphasis on rehabilitation issues]. Sportverletz Sportschaden. 2007 Mar;21(1):34-40. doi: 10.1055/s-2007-963040. German.'}, {'pmid': '17138636', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Grasemann R, Spies M, Vogt PM. Intermittent KoldBlue cryotherapy of 3x10 min changes mid-portion Achilles tendon microcirculation. Br J Sports Med. 2007 Jun;41(6):e4. doi: 10.1136/bjsm.2006.030957. Epub 2006 Nov 30.'}, {'pmid': '17127721', 'type': 'BACKGROUND', 'citation': 'Knobloch K. Eccentric training in Achilles tendinopathy: is it harmful to tendon microcirculation? Br J Sports Med. 2007 Jun;41(6):e2; discussion e2. doi: 10.1136/bjsm.2006.030437. Epub 2006 Nov 24.'}, {'pmid': '16998082', 'type': 'BACKGROUND', 'citation': 'Knobloch K, Grasemann R, Jagodzinski M, Richter M, Zeichen J, Krettek C. Changes of Achilles midportion tendon microcirculation after repetitive simultaneous cryotherapy and compression using a Cryo/Cuff. Am J Sports Med. 2006 Dec;34(12):1953-9. doi: 10.1177/0363546506293701. Epub 2006 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'Athletic tendinopathies of the upper and lower extremity are often therapeutically challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in painful tendons, which are associated with pain-mediating nerve fibres in such tendinopathies. These neovessels are represented by an increased capillary blood flow at the point of pain. Painful eccentric training reduces pain and improves function in Achilles tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with eccentric training is superior to eccentric training alone (evidence level Ib). Long-term results suggest a collagen induction and reduced pain following topical glyceryl trinitrate (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence level Ib). The role of proprioceptive training in tendinopathy has to be determined in future randomized-controlled trials (evidence level II).\n\nThe investigators thought to evaluate the combination of the aforementioned individually successfully therapeutic options in athletes to shorten the recovery period and return to play interval.', 'detailedDescription': 'Interventions:\n\nCombined Power-Doppler-guided sclerosing therapy using Polidocanol (0.5%, 2ml) in 6-8 week intervals combined with extracorporeal focused shockwave therapy (STORZ Duolith 2000impulses 0.25mJ/mm2) every 6-8weeks plus painful daily eccentric training plus daily topical NO'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)\n* patella tendinopathy\n* elbow tendinopathy\n* informed consent\n\nExclusion Criteria:\n\n* no informed consent\n* no painful tendons\n* allergy against Polidocanol\n* current treatment with Marcumar'}, 'identificationModule': {'nctId': 'NCT01185951', 'acronym': 'TENDOSHOCK', 'briefTitle': 'TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies', 'orgStudyIdInfo': {'id': 'TENDOSHOCK-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Achilles tendinopathy', 'description': 'Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.', 'interventionNames': ['Drug: Polidocanol', 'Device: Focused extracorporeal shock wave therapy', 'Drug: Topical NO', 'Behavioral: Painful eccentric training in Achilles tendinopathy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patella tendinopathy', 'description': 'Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.', 'interventionNames': ['Drug: Polidocanol', 'Device: Focused extracorporeal shock wave therapy', 'Drug: Topical NO', 'Behavioral: Painful eccentric training for patella tendinopathy on 25° decline board']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epikondylitis', 'description': "Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.", 'interventionNames': ['Drug: Polidocanol', 'Device: Focused extracorporeal shock wave therapy', 'Drug: Topical NO', 'Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar']}], 'interventions': [{'name': 'Polidocanol', 'type': 'DRUG', 'description': 'Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks', 'armGroupLabels': ['Achilles tendinopathy', 'Epikondylitis', 'Patella tendinopathy']}, {'name': 'Focused extracorporeal shock wave therapy', 'type': 'DEVICE', 'description': 'Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks', 'armGroupLabels': ['Achilles tendinopathy', 'Epikondylitis', 'Patella tendinopathy']}, {'name': 'Topical NO', 'type': 'DRUG', 'description': 'Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon', 'armGroupLabels': ['Achilles tendinopathy', 'Epikondylitis', 'Patella tendinopathy']}, {'name': 'Painful eccentric training in Achilles tendinopathy', 'type': 'BEHAVIORAL', 'description': 'Painful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks', 'armGroupLabels': ['Achilles tendinopathy']}, {'name': 'Painful eccentric training for patella tendinopathy on 25° decline board', 'type': 'BEHAVIORAL', 'description': 'Painful eccentric training for patella tendinopathy on a 25° decline board single-stance with 6x15 repetitions per leg and day over at least 12 weeks', 'armGroupLabels': ['Patella tendinopathy']}, {'name': 'Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar', 'type': 'BEHAVIORAL', 'description': 'Painful eccentric training for elbow tendinopathy using a green coloured Thera-Band Flex-Bar with painful supination and pronation with 6x15 repetitions per day over at least 12 weeks', 'armGroupLabels': ['Epikondylitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School, Plastic, Hand and Reconstructive Surgery', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Karsten Knobloch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'PD Dr. Karsten Knobloch', 'oldOrganization': 'Plastic, Hand and Reconstructive Surgery, Hannover Medical School, Germany'}}}}