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

NCT ID: NCT04467450

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-12-15

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

Conditions

Subacromial Bursitis; Subdeltoid Bursitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Botox injection

half of the hemiplegic patients will be injected by botulinum toxin A in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound

Group Type: EXPERIMENTAL

botulinum toxin type A

Intervention Type: DRUG

ultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa

methyl prednisolonate injection

the other half of the hemiplegic patients will be injected by methylprednisolonate in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound

Group Type: ACTIVE_COMPARATOR

Methyl Prednisolonate

Intervention Type: DRUG

ultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa

Interventions

botulinum toxin type A

ultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa

Intervention Type: DRUG

Methyl Prednisolonate

ultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa

Intervention Type: DRUG

Other Intervention Names

botox 100 IU; Depomedrol 40mg /2ml

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Eman Baraka

Assisstant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Baraka, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant Profesoor

Locations

Eman

Banhā, Qalyubia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Eman Baraka, MD

Role: CONTACT

dremanbaraka@yahoo.com

00210032080424

Facility Contacts

Eman Baraka, MD

Role: primary

dremanbaraka@yahoo.com

00201032080424

References

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.

Reference Type: RESULT

PMID: 21368663 (View on PubMed)

Other Identifiers

RC6-5-2020

Identifier Type: -

Identifier Source: org_study_id