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

NCT04467450 | Unknown Early Phase 1

• 1 other identifier: RC6-5-2020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Bursitis; Subdeltoid Bursitis

Keywords

stroke; hemiplegia; botulinum toxin; musculoskeletal ultrasound

Outcome Measures

Primary Outcomes (12)

• visual analog scale (VAS) for pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  One hour before the injection.

• visual analog scale (VAS) for pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  In the 1st follow up visit 2 weeks after the injection

• visual analog scale (VAS) for pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  In the 2nd follow up visit 10 weeks after the injection .

• The Modified Ashworth scale (MAS)

  measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.\[1\] Scoring (taken from Bohannon and Smith, 1987): * 0: No increase in muscle tone * 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM * 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension

  One hour before the injection

• The Modified Ashworth scale (MAS)

  measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.\[1\] Scoring (taken from Bohannon and Smith, 1987): * 0: No increase in muscle tone * 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM * 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension

  In the 1st follow up visit 2 weeks after the injection

• The Modified Ashworth scale (MAS)

  measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.\[1\] Scoring (taken from Bohannon and Smith, 1987): * 0: No increase in muscle tone * 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM * 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension

  In the 2nd follow up visit 10 weeks after the injection

• Fugl-Meyer Assessment (FMA-UE)

  The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.

  One hour before the injection.

• Fugl-Meyer Assessment (FMA-UE)

  The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.

  In the 1st follow up visit 2 weeks after the injection

• Fugl-Meyer Assessment (FMA-UE)

  The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.

  In the 2nd follow up visit 10 weeks after the injection

• Modified Barthel ADL index*

  Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well. Total score of 20 Score \<15 - usually represents moderate disability \<10- usually represents severe disability.

  One hour before the injection.

• Modified Barthel ADL index*

  Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well. Total score of 20 Score \<15 - usually represents moderate disability \<10- usually represents severe disability.

  In the 1st follow up visit 2 weeks after the injection

• Modified Barthel ADL index*

  Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well. Total score of 20 Score \<15 - usually represents moderate disability \<10- usually represents severe disability.

  In the 2nd follow up visit 10 weeks after the injection

Study Arms (2)

Botox injection

EXPERIMENTAL

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

Drug: botulinum toxin type A

methyl prednisolonate injection

ACTIVE COMPARATOR

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

Drug: Methyl Prednisolonate

Interventions

botulinum toxin type A DRUG

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

Also known as: botox 100 IU

Botox injection

Methyl Prednisolonate DRUG

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

Also known as: Depomedrol 40mg /2ml

methyl prednisolonate injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Eman

Banhā, Qalyubia Governorate, 13512, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 21368663 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Botulinum Toxins, Type A; methyl prednisolonate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Eman Baraka, MD

  Assisstant Profesoor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Baraka, MD

CONTACT

00210032080424; dremanbaraka@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 13, 2020
• Study Start: June 1, 2020
• Primary Completion: November 20, 2020
• Study Completion: December 15, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)