Botulinum Toxin A for Shoulder Pain After Stroke

NCT02618603 | Unknown Phase 4

• 1 other identifier: 2016137443
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder pain after stroke is a very common, causing significant morbidity disease. Subacromial and subdeltoid (SASD) bursitis are common causes of pain or disability of the shoulder joint in stroke patients. Traditional therapeutic approaches for the shoulder pain therapy including pharmacotherapy, injection therapy, physical therapy, and behavioural modification. Unfortunately, these therapy methods may not be effective in many patients and long term benefit after treatment is transient, the outcomes may also be incomplete or non-existent. Botulinum toxin A (BoNT-A) is a neurotoxin that can inhibit not only the acetylcholine at the neuromuscular junctions but also other neurotransmitters such as glutamate, substance P and calcitonin gene related peptide, all of which have been indicated in pain transmission. Despite the therapeutic benefit of BTX in alleviating painful muscle spasms, its efficacy in SASD bursitis conditions is less clear. So we perform this study to examine the efficacy of ultrasound guided SASD injection with BoNT-A in reducing refractory shoulder pain after stroke.

Conditions

Stroke; Pain

Keywords

Stroke; Should pain; Botulinum Toxin

Outcome Measures

Primary Outcomes (1)

• Change from baseline of pain score (Numeric Rating Scale, NRS)

  The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.

Secondary Outcomes (2)

• Passive and/or active shoulder range of motion.

  The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.

• Change from baseline of should muscle modified Ashworth scale assess (MAS)

  The outcome will be undertaken at weeks 0 (baseline), 1,2,4,8, and 12 weeks after injection.

Study Arms (2)

BoNT-A treatment group

EXPERIMENTAL

Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u);

Drug: Botulinum toxin A

Triamcinolone acetonide treatment group

ACTIVE COMPARATOR

Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;

Drug: Triamcinolone Acetonide

Interventions

Botulinum toxin A DRUG

Also known as: BoNT-A

BoNT-A treatment group

Triamcinolone Acetonide DRUG

Triamcinolone acetonide treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (6)

• 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.

  PMID: 21368663 RESULT

• 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.

  PMID: 1356988 RESULT

• 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.

  PMID: 20123097 RESULT

• 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.

  PMID: 23698243 RESULT

• 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.

  PMID: 26590864 RESULT

• 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.

  PMID: 26189200 RESULT

MeSH Terms

Conditions

Stroke; Pain

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

TAO WU, MD

CONTACT

86 571 86006054; wutao1880@163.com

JIANHUA LI, MD

CONTACT

86 571 86006054; zjdxsyfkfk@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 1, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 1, 2015

Record last verified: 2015-11

Locations

CN (1)