- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00211718
Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain
Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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).
Comparisons: Intra-articular injection of botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then saline).
Studietyp
Inskrivning
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Maren L Mahowald, MD
- Telefonnummer: 6124674190
- E-post: mahow001@umn.edu
Studera Kontakt Backup
- Namn: Jasvinder A Singh, MD MPH
- Telefonnummer: 6124674190
- E-post: Jasvinder.Singh@va.gov
Studieorter
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55417
- Rekrytering
- Minneapolis VAMC
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Huvudutredare:
- Maren L Mahowald, MD
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Underutredare:
- Hollis E Krug, MD
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Kontakt:
- Jasvinder A Singh, MD MPH
- Telefonnummer: 6124674190
- E-post: Jasvinder.Singh@va.gov
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Kontakt:
- Maren l Mahowald, MD
- Telefonnummer: 612-467-4190
- E-post: mahow001@umn.edu
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Underutredare:
- Jasvinder A Singh, MD MPH
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
• Male or female subjects, 18 years of age or older.
- Written informed consent and written authorization for use or release of health and research study information have been obtained.
- Subject has chronic Shoulder joint pain for more than 1 year.
- Subject has pain >4.5 on numerical rating scale of 0 to 10.
- Ability to follow study instructions and likely to complete all required visits.
- Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable)
- Patients previously treated with intra-articular corticosteroid or viscosupplementation injections.
- 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.
- 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.
- Must be ambulatory and able to perform sit to stand.
Exclusion Criteria:
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- 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.
- 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.
- Known allergy or sensitivity to any of the components in the study medication.
- Evidence of recent alcohol or drug abuse.
- Infection at injection site or systemic infection (postpone study entry until one week following recovery.
- Known, uncontrolled serious systemic disease and/or life expectancy less than 12 months.
- Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
- 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.
- Patients whose pain is rated as less than 4.5 on a 10 point Numerical Pain Rating scale at the screening visit
- Patients on coumadin or heparin because of increased risk of bleeding in the joint
- Serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Change in Pain Score
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Change in Joint Function
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Patient Global Assessment
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: Primary Outcomes:
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Sekundära resultatmått
Resultatmått |
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Pain Relief
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Change in Health Status Quality of Life-SF36
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Physican Assessment of Pain and Global Assessment of Improvement
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Safety Measure,
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Sekundära resultat:
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Change in Disease specific Health Related QOL-WOOS
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Function improvement - Range of Motion, SPADI, Simple Shoulder tes
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Maren L Mahowald, MD, Minneapolis VAMC
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Ledsjukdomar
- Muskuloskeletala sjukdomar
- Artralgi
- Artrit
- Axelvärk
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Kolinerga medel
- Membrantransportmodulatorer
- Acetylkolinfrisättningshämmare
- Neuromuskulära medel
- Botulinumtoxiner
- Botulinumtoxiner, typ A
- abobotulinumtoxinA
Andra studie-ID-nummer
- IRB Protocol Number 03404B
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