Shoulder PainPhase 4dolomtoxNCT04470401
The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A
A Phase 4 study testing AbobotulinumtoxinA and Saline in people with Shoulder Pain, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Stroke is the leading cause of disability in developed countries, and the major cause of mortality in Brazil.It is associated with low quality of life, disability, decreased muscle strength and control due to the hypertonia, spasticity. These pathways can develop inadequate upper and lower limbs functional mechanisms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- AbobotulinumtoxinA and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jun 2019to 5 Mar 2021
- Phase
- Phase 4
- 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
- Spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke;
- Diagnosis of hemiplegic painful shoulder syndrome, regardless of motor dominance;
- Agreement of the patient, family member and / or responsible caregiver to participate in the study.
Who cannot join
- Pain before stroke in shoulder affected by hemiplegia;
- Previous treatment using TXB-A for painful shoulder;
- Cognitive impairment that hinders assessment and collaboration with treatment;
- Counter indication to the botulinum toxin use; Structured joint deformity in the shoulder affected by pain
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is the leading cause of disability in developed countries, and the major cause of mortality in Brazil.It is associated with low quality of life, disability, decreased muscle strength and control due to the hypertonia, spasticity. These pathways can develop inadequate upper and lower limbs functional mechanisms. These changes are linked with disabilities and painful syndromes.
The shoulder pain relationed after stroke has a variable prevalence from 16 to 84%, from mild to severe pain and is relationed as a precursor factor of secondary deformities, depression, longer hospital stay. Its etiology remains controversial with many possibilities as rotator cuff injuries, glenohumeral dislocation, impact syndrome, bicipital tendinitis, hand shoulder syndrome, myofascial painful syndrome, presence of spasticity and contractures, adhesive capsulitis, central pain and others. Its management is controversial and could be done with physical therapy (kinesiotherapy) intra-articular or local injections (muscles and nerves), functional electrical stimulation, acupuncture, herbal medicine, tapping, myofascial painful syndrome treatment, painkillers, anti-inflammatories and antispastic drugs like botulinum toxin A - tested in few studies, case series, against corticosteroids.
Read more
The aim of this study will be to evaluate the effectiveness of the use of 200 units of abobotulinumtoxin against placebo in both pectoralis major and subscapularis: for reducing shoulder pain (Visual Analogue Scale, McGill pain scale), active and passive range of motion(goniometer),upper limb function (Fugl-Meyer test), burden of care questionnaire (apply to caregivers).
This study is designed as a prospective, double-blind, randomized, controlled study in two Rehabilitation Centers (Rehabilitation Center from Santa Casa de São Paulo and Hospital de Clínicas of Universidade de Sao Paulo - Ribeirão Preto).
Read the detailed description
The principal aim will be the pain evaluation (Visual Analogue Scale and McGill pain scale) with the use of 200 units of abobotulinumtoxin (Dysport) against placebo in both pectoralis major and subscapularis, after 01and 04 months of the procedure The secondary objectives will be analysis the active and passive affected shoulder range of motion (goniometer), the upper limb function (Fugl-Meyer test), Burden of care questionnaire (apply to caregivers) and the use of medicine and therapies.
The sample size was calculated to a alpha error (5%), statistical power (80%) and a decrease of 1.4 points in Visual Analogue Scale, totalizing 10 patients per group, to avoid lack of statistical power due to possible drop out we will recruit 12 patients per group.
The muscles selected for this study are the pectoralis major and subscapularis muscles, each receiving 200U of Dysport® distributed in 2 points, guided by electrical stimulation .The evaluations will be performed in 0, 1 and 4 months after the procedure.
The researchers that will apply and evaluate the patients will be blinded. The patients will be randomized by 6 blocks of four.
The inclusion criteria will be spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke; over 18 years old; diagnosis of hemiplegic painful shoulder syndrome, regardless of motor dominance; agreement of the patient, family member and / or responsible caregiver to participate in the study.
The exclusion criteria will be pain before stroke in shoulder affected by hemiplegia; previous treatment using TXB-A for painful shoulder; cognitive impairment that hinders assessment and collaboration with treatment; counterindication to the botulinum toxin use; structured joint deformity in the shoulder affected by pain.
The qualitative variables will be described through percentages of each categories. The quantitative variables will be analyzed for normality by the Komolgorov-Smirnov. The comparison of the value average of the pain variable evaluated by VAS will be performed by the ANOVA test, considering the treatment groups and the moment of evaluation, followed by post hoc comparisons, if the ANOVA test indicates a significant effect group time.The dropouts will be evaluated according to the intention to treat. We will use software Stata11 or similar model
- Conditions
- Shoulder Pain
- Being tested
- AbobotulinumtoxinA, Saline
- Keywords
- Shoulder Pain, Botulinum toxins, Hemiplegia
- Medical subject headings
- Shoulder Pain, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinADrug
application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles
SalineDrug
application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Abobotulinumtoxina 400 IU in 2cc of saline solution Receives: Drug: Saline |
| Abobotulinumtoxina - 400IU | Experimental | placebo (2cc of saline solution) Receives: Drug: AbobotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain in Visual Analogue Scale
Change of 1.4 mm in Visual Analogue Scale (Scale from 0 to 10mm, where 10 is the worst pain sensation and 0 is pain absence
Measured: 1 and 4 months
Secondary outcomes (2)
Change of pain in McGill scale
Change of McGill pain scale in at least 02 categories (in a 20 different categories, and decrease of the total number (maximum of 56 points that represent the worst pain.
Measured: 1 and 4 months
Change Upper Limb function in Fugl Meyer scale
Change of function in at least 03 points in Full Meyer scale that represents a maximum value of 66 that represents the upper limb higher function
Measured: 1 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start5 Jun 2019
- Primary completion5 Sep 2020
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms, a placebo group versus a abobotulinumtoxina (400 IU), to be applied in both muscles (200 IU each) subscapularis and pectoral major
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470401
- Sponsor's protocol ID
- Eduardo Rocha
- Acronym
- dolomtox
- Status last verified
- Mar 2021
- First submitted
- 10 Jul 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A
- ClinicalTrials.gov ID
- NCT04470401
- Acronym / sponsor ID
- dolomtox / Eduardo Rocha
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain, Botulinum toxins, Hemiplegia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 14 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.
Stroke is the leading cause of disability in developed countries, and the major cause of mortality in Brazil.It is associated with low quality of life, disability, decreased muscle strength and control due to the hypertonia, spasticity. These pathways can develop inadequate upper and lower limbs functional mechanisms. These changes are linked with disabilities and painful syndromes.
The shoulder pain relationed after stroke has a variable prevalence from 16 to 84%, from mild to severe pain and is relationed as a precursor factor of secondary deformities, depression, longer hospital stay. Its etiology remains controversial with many possibilities as rotator cuff injuries, glenohumeral dislocation, impact syndrome, bicipital tendinitis, hand shoulder syndrome, myofascial painful syndrome, presence of spasticity and contractures, adhesive capsulitis, central pain and others. Its management is controversial and could be done with physical therapy (kinesiotherapy) intra-articular or local injections (muscles and nerves), functional electrical stimulation, acupuncture, herbal medicine, tapping, myofascial painful syndrome treatment, painkillers, anti-inflammatories and antispastic drugs like botulinum toxin A - tested in few studies, case series, against corticosteroids.
The aim of this study will be to evaluate the effectiveness of the use of 200 units of abobotulinumtoxin against placebo in both pectoralis major and subscapularis: for reducing shoulder pain (Visual Analogue Scale, McGill pain scale), active and passive range of motion(goniometer),upper limb function (Fugl-Meyer test), burden of care questionnaire (apply to caregivers).
This study is designed as a prospective, double-blind, randomized, controlled study in two Rehabilitation Centers (Rehabilitation Center from Santa Casa de São Paulo and Hospital de Clínicas of Universidade de Sao Paulo - Ribeirão Preto).
Detailed description
The principal aim will be the pain evaluation (Visual Analogue Scale and McGill pain scale) with the use of 200 units of abobotulinumtoxin (Dysport) against placebo in both pectoralis major and subscapularis, after 01and 04 months of the procedure The secondary objectives will be analysis the active and passive affected shoulder range of motion (goniometer), the upper limb function (Fugl-Meyer test), Burden of care questionnaire (apply to caregivers) and the use of medicine and therapies.
The sample size was calculated to a alpha error (5%), statistical power (80%) and a decrease of 1.4 points in Visual Analogue Scale, totalizing 10 patients per group, to avoid lack of statistical power due to possible drop out we will recruit 12 patients per group.
The muscles selected for this study are the pectoralis major and subscapularis muscles, each receiving 200U of Dysport® distributed in 2 points, guided by electrical stimulation .The evaluations will be performed in 0, 1 and 4 months after the procedure.
The researchers that will apply and evaluate the patients will be blinded. The patients will be randomized by 6 blocks of four.
The inclusion criteria will be spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke; over 18 years old; diagnosis of hemiplegic painful shoulder syndrome, regardless of motor dominance; agreement of the patient, family member and / or responsible caregiver to participate in the study.
The exclusion criteria will be pain before stroke in shoulder affected by hemiplegia; previous treatment using TXB-A for painful shoulder; cognitive impairment that hinders assessment and collaboration with treatment; counterindication to the botulinum toxin use; structured joint deformity in the shoulder affected by pain.
The qualitative variables will be described through percentages of each categories. The quantitative variables will be analyzed for normality by the Komolgorov-Smirnov. The comparison of the value average of the pain variable evaluated by VAS will be performed by the ANOVA test, considering the treatment groups and the moment of evaluation, followed by post hoc comparisons, if the ANOVA test indicates a significant effect group time.The dropouts will be evaluated according to the intention to treat. We will use software Stata11 or similar model
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two arms, a placebo group versus a abobotulinumtoxina (400 IU), to be applied in both muscles (200 IU each) subscapularis and pectoral major
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineAbobotulinumtoxina 400 IU in 2cc of saline solution |
| Abobotulinumtoxina - 400IU | Experimental | Drug: AbobotulinumtoxinAplacebo (2cc of saline solution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke;
- Diagnosis of hemiplegic painful shoulder syndrome, regardless of motor dominance;
- Agreement of the patient, family member and / or responsible caregiver to participate in the study.
Key exclusion criteria (4 listed)
- Pain before stroke in shoulder affected by hemiplegia;
- Previous treatment using TXB-A for painful shoulder;
- Cognitive impairment that hinders assessment and collaboration with treatment;
- Counter indication to the botulinum toxin use; Structured joint deformity in the shoulder affected by pain
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 |
|---|---|---|
| AbobotulinumtoxinAapplication of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles | Drug | Abobotulinumtoxina - 400IU |
| Salineapplication of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles | Drug | Placebo |
Primary outcome
Change in Pain in Visual Analogue Scale
Time frame: 1 and 4 months
Change of 1.4 mm in Visual Analogue Scale (Scale from 0 to 10mm, where 10 is the worst pain sensation and 0 is pain absence
2 secondary outcomes
Change of pain in McGill scale
Time frame: 1 and 4 months
Change Upper Limb function in Fugl Meyer scale
Time frame: 1 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AbobotulinumtoxinA and Saline in people with Shoulder Pain, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 2021. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain in Visual Analogue Scale (time frame: 1 and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.