Botulinum Toxin A for Shoulder Pain After Stroke

Phase 4

• Conditions: Stroke; Pain
• Interventions: Drug: Triamcinolone Acetonide; Drug: Botulinum toxin A

• Registration Number: NCT02618603
• Lead Sponsor: Sir Run Run Shaw Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-11
• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2015-11-27
• Last Update Submitted: 2015-11-27
• Study First Posted: 2015-12-01
• Last Update Posted: 2015-12-01
• Study Start: 2016-02
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Stroke patients with pain around the shoulder or lateral deltoid area and deteriorated during active or passive overhead activity;
2. Neer and/or Hawkins tests (+);
3. NRS>5 at rest;
4. Symptoms lasted for at least for 2 months and were unresponsive to analgesic medication or physical therapy for 1 month.
5. Subjects voluntarily sign the informed consent.
6. Age between 18 and 80 years old. -

Exclusion Criteria

1. Received earlier subacromial injections of corticosteroids or botulinuim toxin in the last 6 months;

2. Shoulder fracture, glenohumeral osteoarthritis, bone tumors or osteonecrosis in plain radiographs.

3. Known allergy or sensitivity to study medication or its components.

4. Infection or dermatological condition at the injection sites.

5. 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.

6. 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

7. 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%).

8. Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function.

9. Patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients.

10. Presence of clinically unstable severe cardiovascular, renal or respiratory disease

11. Researchers believe there are other factors unfit to participate in this study of patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcinolone acetonide treatment group	Triamcinolone Acetonide	Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;
BoNT-A treatment group	Botulinum toxin A	Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u);

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital, Medical College of Zhejiang University; 🇨🇳 Hang Zhou, Zhejiang, China