Status:

UNKNOWN

Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain

Lead Sponsor:

Benha University

Conditions:

Subacromial Bursitis

Subdeltoid Bursitis

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief Summary

Good shoulder function is a prerequisite for effective hand function, as well as for performing multiple tasks involving mobility, ambulation, and activities of daily living (ADL). A common sequela of...

Detailed Description

Subject and methods: Patients with clinical diagnosis of hemiparesis on the criteria of the World Health Organization (WHO, 2001) will be recruited from Benha university hospitals' outpatients and inp...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Clinical diagnosis of hemiparesis caused by stroke diagnosed according to World Health Organization (WHO, 2001),
  • Shoulder pain for more than 3 months.
  • pain score \>3 on a pain visual analog scale at rest.
  • pain score \>5 on a pain visual analog scale during activity.
  • pain was not relieved by conventional treatment (common analgesics, and non-steroidal anti-inflammatory drugs, slings or physical modalities).
  • No significant spasticity in the upper shoulder joint, defined as Modified Ashworth Scale (MAS) score ≤2
  • Ultrasonographically diagnosed subacromial subdeltoid (SASD ) bursitis.
  • Exclusion Criteria :
  • history of shoulder pain or limited ROM before stroke.
  • previous trauma history affecting shoulder
  • shoulder subluxation
  • shoulder diseases ( osteoarthritis , rheumatoid arthritis , others )
  • other neurologic diseases
  • resistance greater than a MAS score 2
  • previous shoulder botulinum toxin or steroid injection in the affected side or known allergy for botulinum toxin.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 15 2020

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT04467450

    Start Date

    June 1 2020

    End Date

    December 15 2020

    Last Update

    October 8 2020

    Active Locations (1)

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    1

    Eman

    Banhā, Qalyubia Governorate, Egypt, 13512