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AzTrials

StrokePhase 4NCT02618603

Botulinum Toxin A for Shoulder Pain After Stroke

A Phase 4 study testing Botulinum toxin A and Triamcinolone Acetonide in people with Stroke and Pain, run by Sir Run Run Shaw Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Pain
What is being tested?
Botulinum toxin A and Triamcinolone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Feb 2016to Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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. -

Who cannot join

  • 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
Show all 12Show fewer
  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

TAO WU, MD contact

86 571 86006054

wutao1880@163.com

JIANHUA LI, MD contact

86 571 86006054

zjdxsyfkfk@126.com

China1 site

  • Sir Run Run Shaw Hospital, Medical College of Zhejiang University

    Hangzhou, Zhejiang, 310016

Other trials in China

About this study

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

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
Being tested
Botulinum toxin A, Triamcinolone Acetonide
Keywords
Stroke, Should pain, Botulinum Toxin
Medical subject headings
Stroke, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin ADrug

    Also called BoNT-A

  • Triamcinolone AcetonideDrug

Study groups in NCT02618603
Study groupRoleWhat they receive
BoNT-A treatment groupExperimentalUltrasound guided sub-acromial bursa injection with BoNT-A (100 u);
Receives: Drug: Botulinum toxin A
Triamcinolone acetonide treatment groupActive comparatorUltrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;
Receives: Drug: Triamcinolone Acetonide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (2)

  1. Passive and/or active shoulder range of motion.

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02618603
Sponsor's protocol ID
2016137443
Other IDs
2016137443
Status last verified
Nov 2015
First submitted
27 Nov 2015
Last updated
1 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21368663

  • 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.

    PubMed 1356988

  • 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.

    PubMed 20123097

  • 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.

    PubMed 23698243

  • 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.

    PubMed 26590864

  • 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.

    PubMed 26189200

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Botulinum toxin A and Triamcinolone Acetonide in people with Stroke and Pain, run by Sir Run Run Shaw Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact TAO WU, MD (86 571 86006054, wutao1880@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02618603, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2015.

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