Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00211718
Status:
UNKNOWN
Last Update Posted:
2005-11-03
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'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': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-07'}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2007-06'}, 'lastUpdateSubmitDate': '2005-11-02', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2005-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': ': Primary Outcomes:'}, {'measure': 'Change in Pain Score'}, {'measure': 'Change in Joint Function'}, {'measure': 'Patient Global Assessment'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcomes:'}, {'measure': 'Pain Relief'}, {'measure': 'Change in Health Status Quality of Life-SF36'}, {'measure': 'Change in Disease specific Health Related QOL-WOOS'}, {'measure': 'Function improvement - Range of Motion, SPADI, Simple Shoulder tes'}, {'measure': 'Physican Assessment of Pain and Global Assessment of Improvement'}, {'measure': 'Safety Measure,'}]}, 'conditionsModule': {'keywords': ['shoulder pain', 'arthritis', 'intra-articular botulinum toxin a', 'joint pain'], 'conditions': ['Arthritis', 'Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.', 'detailedDescription': 'Chronic shoulder pain unresponsive to oral medications and intra-articular corticosteroids is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter).\n\nComparisons: Intra-articular injection of botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then saline).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Male or female subjects, 18 years of age or older.\n\n * Written informed consent and written authorization for use or release of health and research study information have been obtained.\n * Subject has chronic Shoulder joint pain for more than 1 year.\n * Subject has pain \\>4.5 on numerical rating scale of 0 to 10.\n * Ability to follow study instructions and likely to complete all required visits.\n * Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable)\n * Patients previously treated with intra-articular corticosteroid or viscosupplementation injections.\n * Patients with rheumatoid arthritis must have failed therapy with standard DMARDs (disease modifying anti-rheumatic drugs) and anti-TNF agents unless they have a contraindication to TNF blockers.\n * Patients who were considered not to be candidates for Shoulder joint replacement because of young age, abnormalities in periarticular tissues or because of co-morbid conditions.\n * Must be ambulatory and able to perform sit to stand.\n\nExclusion Criteria:\n\n* Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.\n* Any medical condition that may put the subject at increased risk with exposure to botulinum neurotoxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, any other disorder that might interfere with neuromuscular function or the presence of severe peripheral neuropathy.\n* Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.\n* Known allergy or sensitivity to any of the components in the study medication.\n* Evidence of recent alcohol or drug abuse.\n* Infection at injection site or systemic infection (postpone study entry until one week following recovery.\n* Known, uncontrolled serious systemic disease and/or life expectancy less than 12 months.\n* Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.\n* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.\n* Patients whose pain is rated as less than 4.5 on a 10 point Numerical Pain Rating scale at the screening visit\n* Patients on coumadin or heparin because of increased risk of bleeding in the joint\n* Serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment."}, 'identificationModule': {'nctId': 'NCT00211718', 'briefTitle': 'Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain', 'organization': {'class': 'FED', 'fullName': 'Minneapolis Veterans Affairs Medical Center'}, 'officialTitle': 'Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB Protocol Number 03404B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intra-articular botulinum toxin type a', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maren l Mahowald, MD', 'role': 'CONTACT', 'email': 'mahow001@umn.edu', 'phone': '612-467-4190'}, {'name': 'Jasvinder A Singh, MD MPH', 'role': 'CONTACT', 'email': 'Jasvinder.Singh@va.gov', 'phone': '6124674190'}, {'name': 'Maren L Mahowald, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jasvinder A Singh, MD MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hollis E Krug, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Minneapolis VAMC', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Maren L Mahowald, MD', 'role': 'CONTACT', 'email': 'mahow001@umn.edu', 'phone': '6124674190'}, {'name': 'Jasvinder A Singh, MD MPH', 'role': 'CONTACT', 'email': 'Jasvinder.Singh@va.gov', 'phone': '6124674190'}], 'overallOfficials': [{'name': 'Maren L Mahowald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}, {'name': 'Center for Veterans Research and Education', 'class': 'OTHER'}]}}}