Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain
Primary Purpose
Subacromial Bursitis, Subdeltoid Bursitis
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
botulinum toxin type A
Methyl Prednisolonate
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Bursitis focused on measuring stroke, hemiplegia, botulinum toxin, musculoskeletal ultrasound
Eligibility Criteria
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.
Sites / Locations
- EmanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botox injection
methyl prednisolonate injection
Arm Description
half of the hemiplegic patients will be injected by botulinum toxin A in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound
the other half of the hemiplegic patients will be injected by methylprednisolonate in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound
Outcomes
Primary Outcome Measures
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).
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).
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).
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
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
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
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04467450
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 20, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Bursitis, Subdeltoid Bursitis
Keywords
stroke, hemiplegia, botulinum toxin, musculoskeletal ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botox injection
Arm Type
Experimental
Arm Description
half of the hemiplegic patients will be injected by botulinum toxin A in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound
Arm Title
methyl prednisolonate injection
Arm Type
Active Comparator
Arm Description
the other half of the hemiplegic patients will be injected by methylprednisolonate in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound
Intervention Type
Drug
Intervention Name(s)
botulinum toxin type A
Other Intervention Name(s)
botox 100 IU
Intervention Description
ultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa
Intervention Type
Drug
Intervention Name(s)
Methyl Prednisolonate
Other Intervention Name(s)
Depomedrol 40mg /2ml
Intervention Description
ultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa
Primary Outcome Measure Information:
Title
visual analog scale (VAS) for pain
Description
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).
Time Frame
One hour before the injection.
Title
visual analog scale (VAS) for pain
Description
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).
Time Frame
In the 1st follow up visit 2 weeks after the injection
Title
visual analog scale (VAS) for pain
Description
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).
Time Frame
In the 2nd follow up visit 10 weeks after the injection .
Title
The Modified Ashworth scale (MAS)
Description
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
Time Frame
One hour before the injection
Title
The Modified Ashworth scale (MAS)
Description
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
Time Frame
In the 1st follow up visit 2 weeks after the injection
Title
The Modified Ashworth scale (MAS)
Description
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
Time Frame
In the 2nd follow up visit 10 weeks after the injection
Title
Fugl-Meyer Assessment (FMA-UE)
Description
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.
Time Frame
One hour before the injection.
Title
Fugl-Meyer Assessment (FMA-UE)
Description
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.
Time Frame
In the 1st follow up visit 2 weeks after the injection
Title
Fugl-Meyer Assessment (FMA-UE)
Description
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.
Time Frame
In the 2nd follow up visit 10 weeks after the injection
Title
Modified Barthel ADL index*
Description
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.
Time Frame
One hour before the injection.
Title
Modified Barthel ADL index*
Description
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.
Time Frame
In the 1st follow up visit 2 weeks after the injection
Title
Modified Barthel ADL index*
Description
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.
Time Frame
In the 2nd follow up visit 10 weeks after the injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Baraka, MD
Phone
00210032080424
Email
dremanbaraka@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Baraka, MD
Organizational Affiliation
Assisstant Profesoor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eman
City
Banhā
State/Province
Qalyubia
ZIP/Postal Code
13512
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Baraka, MD
Phone
00201032080424
Email
dremanbaraka@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21368663
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.
Results Reference
result
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Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain
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