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Botulinum Toxin A for Shoulder Pain After Stroke

Primary Purpose

Stroke, Pain

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Botulinum toxin A

Triamcinolone Acetonide

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Should pain, Botulinum Toxin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
-

Sites / Locations

Sir Run Run Shaw Hospital, Medical College of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BoNT-A treatment group

Triamcinolone acetonide treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Passive and/or active shoulder range of motion.

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

Full Information

NCT ID

NCT02618603

First Posted

November 27, 2015

Last Updated

November 27, 2015

Sponsor

Sir Run Run Shaw Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02618603

Brief Title

Botulinum Toxin A for Shoulder Pain After Stroke

Official Title

The Effectiveness of Ultrasound Guided Sub-acromial Bursa Injection With Botulinum Toxin A in for Refractory Shoulder Pain After Stroke.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sir Run Run Shaw Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Pain

Keywords

Stroke, Should pain, Botulinum Toxin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BoNT-A treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Triamcinolone acetonide treatment group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin A

Other Intervention Name(s)

BoNT-A

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Passive and/or active shoulder range of motion.

Time Frame

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

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

TAO WU, MD

Phone

86 571 86006054

wutao1880@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

JIANHUA LI, MD

Phone

86 571 86006054

zjdxsyfkfk@126.com

Facility Information:

Facility Name

Sir Run Run Shaw Hospital, Medical College of Zhejiang University

City

Hang Zhou

State/Province

Zhejiang

ZIP/Postal Code

310016

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

21368663

Citation

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.

Results Reference

result

PubMed Identifier

1356988

Citation

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.

Results Reference

result

PubMed Identifier

20123097

Citation

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.

Results Reference

result

PubMed Identifier

23698243

Citation

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.

Results Reference

result

PubMed Identifier

26590864

Citation

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.

Results Reference

result

PubMed Identifier

26189200

Citation

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.

Results Reference

result

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Botulinum Toxin A for Shoulder Pain After Stroke

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