Clinical trial NCT04467450: Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain
Official title: Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain: Comparative Study Versus Corticosteroid Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Subacromial Bursitis
Subdeltoid Bursitis
Keywords: stroke
hemiplegia
botulinum toxin
musculoskeletal ultrasound
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 stroke is hemiplegic shoulder pain, which can hamper functional recovery and subsequently lead to disability. Hemiplegic shoulder pain can begin as early as 2 weeks post stroke but typically occurs within 2-3 months post stroke.

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 inpatients units of Rheumatology ,Rehabilitation and Physical medicine department The diagnosis of stroke was confirmed by the findings of either brain CT or MRI.

All patients should have localized severe shoulder pain of the paretic upper limb with or without limitation of shoulder range of motion (ROM) with the following inclusion criteria:

Hemiplegic shoulder pain (HSP) duration at least 3 months, pain score \>3 on a pain visual analog scale (VAS) of 0 to 10 cm (0 no pain, 10 worst possible pain) at rest, and/or pain at movement score \>5 on VAS during passive shoulder abduction, pain was not relieved by conventional treatment (common analgesics, such as paracetamol and non-steroidal anti-inflammatory drugs; slings; physical modalities such as transcutaneous electrical nerve stimulation of shoulder muscles or manual therapy). No significant spasticity in the upper shoulder joint, defined as Modified Ashworth Scale (MAS) score ≤2 , ultrasonographically diagnosed subacromial subdeltoid (SASD ) bursitis. previous shoulder steroid or botulinum toxin A injection in the affected side or known allergy for botulinum toxin.

Complete history will be addressed from all subjects emphasizing the age, sex, type of stroke (hemorrhagic, thrombotic) ,duration of the stroke, side of hemiplegia , duration of shoulder pain .Complete neurological and musculoskeletal examination .All patients will be examined by a single independent physiatrist.

Patients will be classified based on the type of the injected material into 2 categories: 18 patients will be injected by 20 IU botulinum Toxin A, ( BoNT/A) group and 18 patients will be injected by 40 mg methyl prednisolone (steroid group) The assessment of therapeutic effects will be performed at the start of the study, and in the 3rd and 10th weeks. Shoulder pain will quantified by VAS score at rest (night pain ) and during the day ( movement pain ) .

The physiatrist who will carry out the initial assessment and will perform the intra-articular injection will not participate in follow-up assessments.

Upper limb motor function was assessed sensorimotor function assessment for the upper extremity domain of the Fugl-Meyer Assessment (FMA-UE) .

Spasticity around the shoulder will be assessed by MAS. Physical disability and behavior related to activities of daily living will be assessed by Modified Barthel ADL index for stroke patients .

Subacromial subdeltoid bursitis(SASD) will be assessed in the paretic shoulder by high frequency probe SASD bursitis if there is thickness ≥ 2mm and / or effusion or both

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of hemiparesis caused by stroke diagnosed according to World Health Organization (WHO, 2001),
2. Shoulder pain for more than 3 months.
3. pain score \>3 on a pain visual analog scale at rest.
4. pain score \>5 on a pain visual analog scale during activity.
5. pain was not relieved by conventional treatment (common analgesics, and non-steroidal anti-inflammatory drugs, slings or physical modalities).
6. No significant spasticity in the upper shoulder joint, defined as Modified Ashworth Scale (MAS) score ≤2
7. Ultrasonographically diagnosed subacromial subdeltoid (SASD ) bursitis.

Exclusion Criteria :

1. history of shoulder pain or limited ROM before stroke.
2. previous trauma history affecting shoulder
3. shoulder subluxation
4. shoulder diseases ( osteoarthritis , rheumatoid arthritis , others )
5. other neurologic diseases
6. resistance greater than a MAS score 2
7. previous shoulder botulinum toxin or steroid injection in the affected side or known allergy for botulinum toxin.

Primary outcomes:
measure: visual analog scale (VAS) for pain
timeFrame: One hour before the injection.
measure: visual analog scale (VAS) for pain
timeFrame: In the 1st follow up visit 2 weeks after the injection
measure: visual analog scale (VAS) for pain
timeFrame: In the 2nd follow up visit 10 weeks after the injection .
measure: The Modified Ashworth scale (MAS)
timeFrame: One hour before the injection
measure: The Modified Ashworth scale (MAS)
timeFrame: In the 1st follow up visit 2 weeks after the injection
measure: The Modified Ashworth scale (MAS)
timeFrame: In the 2nd follow up visit 10 weeks after the injection
measure: Fugl-Meyer Assessment (FMA-UE)
timeFrame: One hour before the injection.
measure: Fugl-Meyer Assessment (FMA-UE)
timeFrame: In the 1st follow up visit 2 weeks after the injection
measure: Fugl-Meyer Assessment (FMA-UE)
timeFrame: In the 2nd follow up visit 10 weeks after the injection
measure: Modified Barthel ADL index*
timeFrame: One hour before the injection.
measure: Modified Barthel ADL index*
timeFrame: In the 1st follow up visit 2 weeks after the injection
measure: Modified Barthel ADL index*
timeFrame: In the 2nd follow up visit 10 weeks after the injection
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Eman
state: Qalyubia
Study officials:
affiliation: Assisstant Profesoor
name: Eman Baraka, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.