Subacromial BursitisEarly Phase 1NCT04467450
Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain
A Early Phase 1 study testing botulinum toxin type A and Methyl Prednisolonate in people with Subacromial Bursitis and Subdeltoid Bursitis, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Bursitis, Subdeltoid Bursitis
- What is being tested?
- botulinum toxin type A and Methyl Prednisolonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 15 Dec 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Eman
Banhā, Qalyubia Governorate, 13512
Eman Baraka, MD, 00201032080424, dremanbaraka@yahoo.com
About this study
Official title: Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain: Comparative Study Versus Corticosteroid Injection
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.
Read the 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
- Being tested
- botulinum toxin type A, Methyl Prednisolonate
- Keywords
- stroke, hemiplegia, botulinum toxin, musculoskeletal ultrasound
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called botox 100 IU
ultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa
Methyl PrednisolonateDrug
Also called Depomedrol 40mg /2ml
ultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Methyl Prednisolonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: In the 2nd follow up visit 10 weeks after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jun 2020
- Primary completion20 Nov 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial BursitisStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Baraka, Benha University
- Investigators
- Eman Baraka, MD, Principal investigator, Assisstant Profesoor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467450
- Sponsor's protocol ID
- RC6-5-2020
- Status last verified
- Oct 2020
- First submitted
- 3 Jul 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21368663
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain: Comparative Study Versus Corticosteroid Injection
- ClinicalTrials.gov ID
- NCT04467450
- Acronym / sponsor ID
- RC6-5-2020
- Conditions
- Subacromial Bursitis, Subdeltoid Bursitis
- Keywords
- stroke, hemiplegia, botulinum toxin, musculoskeletal ultrasound
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox injection | Experimental | Drug: botulinum toxin type Ahalf of the hemiplegic patients will be injected by botulinum toxin A in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound |
| methyl prednisolonate injection | Active comparator | Drug: Methyl Prednisolonatethe other half of the hemiplegic patients will be injected by methylprednisolonate in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin type AAlso: botox 100 IUultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa | Drug | Botox injection |
| Methyl PrednisolonateAlso: Depomedrol 40mg /2mlultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa | Drug | methyl prednisolonate injection |
Primary outcome
visual analog scale (VAS) for pain
Time frame: One hour before the injection.
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
Time frame: In the 1st follow up visit 2 weeks after the injection
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
Time frame: In the 2nd follow up visit 10 weeks after the injection .
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)
Time frame: One hour before the injection
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)
Time frame: In the 1st follow up visit 2 weeks after the injection
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)
Time frame: In the 2nd follow up visit 10 weeks after the injection
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)
Time frame: One hour before the injection.
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)
Time frame: In the 1st follow up visit 2 weeks after the injection
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)
Time frame: In the 2nd follow up visit 10 weeks after the injection
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*
Time frame: One hour before the injection.
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*
Time frame: In the 1st follow up visit 2 weeks after the injection
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*
Time frame: In the 2nd follow up visit 10 weeks after the injection
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Results publication: PubMed 21368663Lee 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.
- Individual participant dataSharing planned: No
Related trials for Subacromial Bursitis
Enrolling by invitation
AI-Assisted Ultrasound Therapy for Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
Rotator Cuff Related Shoulder Pain, Subacromial Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Baraka, MD principal investigator
Assisstant Profesoor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing botulinum toxin type A and Methyl Prednisolonate in people with Subacromial Bursitis and Subdeltoid Bursitis, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Baraka, MD (00210032080424, dremanbaraka@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (VAS) for pain (time frame: One hour before the injection.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.