Botulinum Toxin A for Shoulder Pain After Stroke

Not yet recruiting

Phase 4 Results N/A

Trial Description

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

Interventions

  • Botulinum toxin A Drug
    ARM 1: Kind: Experimental
    Label: BoNT-A treatment group
    Description: Ultrasound guided sub-acromial bursa injection with BoNT-A (100 u);
  • Triamcinolone Acetonide Drug
    ARM 1: Kind: Experimental
    Label: Triamcinolone acetonide treatment group
    Description: Ultrasound guided sub-acromial bursa injection with Triamcinolone acetonide (40mg)+1% Lidocaine 2 ml;

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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. No
Secondary 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. No
Secondary 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. No

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