Botulinum Toxin A for Shoulder Pain After Stroke
The Effectiveness of Ultrasound Guided Sub-acromial Bursa Injection With Botulinum Toxin A in for Refractory Shoulder Pain After Stroke.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Forventet)
Tilmelding
Fase
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: TAO WU, MD
- Telefonnummer: 86 571 86006054
- E-mail: wutao1880@163.com
Undersøgelse Kontakt Backup
- Navn: JIANHUA LI, MD
- Telefonnummer: 86 571 86006054
- E-mail: zjdxsyfkfk@126.com
Studiesteder
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Zhejiang
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Hang Zhou, Zhejiang, Kina, 310016
- Sir Run Run Shaw Hospital, Medical College of Zhejiang University
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Stroke patients with pain around the shoulder or lateral deltoid area and deteriorated during active or passive overhead activity;
- Neer and/or Hawkins tests (+);
- NRS>5 at rest;
- Symptoms lasted for at least for 2 months and were unresponsive to analgesic medication or physical therapy for 1 month.
- Subjects voluntarily sign the informed consent.
- Age between 18 and 80 years old. -
Exclusion Criteria:
- Received earlier subacromial injections of corticosteroids or botulinuim toxin in the last 6 months;
- Shoulder fracture, glenohumeral osteoarthritis, bone tumors or osteonecrosis in plain radiographs.
- Known allergy or sensitivity to study medication or its components.
- Infection or dermatological condition at the injection sites.
- Any medical condition that may put the subject at increased risk with exposure , including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function.
- QTc criteria: QTc ≥ 450 millisecond (msec) or≥480msec for subjects with Bundle Branch Block-values based on either single electrocardiogram (ECG) values or triplicate ECG averaged QTc values obtained over a brief recording period
- Liver function tests: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2xULN; alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function.
- Patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients.
- Presence of clinically unstable severe cardiovascular, renal or respiratory disease
Researchers believe there are other factors unfit to participate in this study of patients.
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: BoNT-A treatment group
Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u);
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Andre navne:
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Aktiv komparator: Triamcinolone acetonide treatment group
Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline of pain score (Numeric Rating Scale, NRS)
Tidsramme: The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
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The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Passive and/or active shoulder range of motion.
Tidsramme: The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
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The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
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Change from baseline of should muscle modified Ashworth scale assess (MAS)
Tidsramme: The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
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The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Lee JH, Lee SH, Song SH. Clinical effectiveness of botulinum toxin type B in the treatment of subacromial bursitis or shoulder impingement syndrome. Clin J Pain. 2011 Jul-Aug;27(6):523-8. doi: 10.1097/AJP.0b013e31820e1310.
- McMahon HT, Foran P, Dolly JO, Verhage M, Wiegant VM, Nicholls DG. Tetanus toxin and botulinum toxins type A and B inhibit glutamate, gamma-aminobutyric acid, aspartate, and met-enkephalin release from synaptosomes. Clues to the locus of action. J Biol Chem. 1992 Oct 25;267(30):21338-43.
- Bach-Rojecky L, Salkovic-Petrisic M, Lackovic Z. Botulinum toxin type A reduces pain supersensitivity in experimental diabetic neuropathy: bilateral effect after unilateral injection. Eur J Pharmacol. 2010 May 10;633(1-3):10-4. doi: 10.1016/j.ejphar.2010.01.020. Epub 2010 Feb 1.
- Hsieh LF, Hsu WC, Lin YJ, Wu SH, Chang KC, Chang HL. Is ultrasound-guided injection more effective in chronic subacromial bursitis? Med Sci Sports Exerc. 2013 Dec;45(12):2205-13. doi: 10.1249/MSS.0b013e31829b183c.
- Wu T, Song HX, Dong Y, Li JH. Ultrasound-guided versus blind subacromial-subdeltoid bursa injection in adults with shoulder pain: A systematic review and meta-analysis. Semin Arthritis Rheum. 2015 Dec;45(3):374-8. doi: 10.1016/j.semarthrit.2015.05.011. Epub 2015 May 21.
- Wu T, Fu Y, Song HX, Ye Y, Dong Y, Li JH. Effectiveness of Botulinum Toxin for Shoulder Pain Treatment: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2015 Dec;96(12):2214-20. doi: 10.1016/j.apmr.2015.06.018. Epub 2015 Jul 17.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Forventet)
Primær færdiggørelse
Studieafslutning (Forventet)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Smerte
- Neurologiske manifestationer
- Ledsygdomme
- Muskuloskeletale sygdomme
- Artralgi
- Slag
- Skuldersmerter
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Enzymhæmmere
- Anti-inflammatoriske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Membrantransportmodulatorer
- Acetylcholin-frigivelseshæmmere
- Neuromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
- abobotulinumtoxinA
- Triamcinolon
- Triamcinolonacetonid
- Triamcinolonhexacetonid
- Triamcinolondiacetat
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 2016137443 (Andet bevillings-/finansieringsnummer: Medical Science and Technology projects of Zhejiang Provincial Health Department)
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