Post-stroke Shoulder Pain and SpasticityNCT00661089
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
A study testing Botulinum Toxin Type A - OnabotulinumtoxinA in people with Post-stroke Shoulder Pain and Spasticity, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Shoulder Pain and Spasticity
- What is being tested?
- Botulinum Toxin Type A - OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Post stroke greater than 2 months
- Shoulder pain despite PT/OT interventions
- Weight greater than 88 lbs
- Stable medically
- Spasticity
Who cannot join
- Myasthenia gravis or other medical conditions that preclude use of botulinum toxin
- Pregnancy
- Infection or dermatologic conditions at the injection site
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60302
About this study
Official title: "A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity"
The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.
Read the detailed description
Subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. Following an initial screening visit involving a history and physical examination, subjects will be entered in to the study if they have significant spasticity of shoulder internal rotation/adduction associated with pain rated at least a 4 on the VAS for pain. Subjects will also be given a cognitive screening in which they will be asked to rate pain in hypothetical situations.
Shoulder pain is a frequent complication following hemiplegic stroke, and may result in further disability. Spasticity is also a complication following stroke . Botulinum toxin is used in the treatment of post-stroke spasticity and may also have pain modulating effects. Participants in this study will be asked to make total of 6 visits over a period of approximately 13 weeks. Eligible subjects will be randomized to 100 to 200 units of botulinum toxin type injected into the pectoralis major at the second visit. If there is significant spasticity for shoulder extension, subjects will also receive injections into the teres major. Subjects will be followed up with assessments of pain, functioning, active and passive range of motion and depression following the initial injection. At the 12 weeks post injection visit, the blinding will be broken and subjects initially injected with placebo will be injected with the active drug. This will be done to give all subjects an opportunity to receive the active drug, as well as to assess the effects of any differences with delayed treatment. All subjects will return 4 weeks later to repeat the same assessments above. Subjects will be called at one year post study enrollment for repeat pain ratings and for information regarding subsequent treatments.
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- Conditions
- Post-stroke Shoulder Pain and Spasticity
- Being tested
- Botulinum Toxin Type A - OnabotulinumtoxinA, Placebo (Saline)
- Keywords
- stroke, shoulder pain, spasticity
- Medical subject headings
- Muscle Spasticity, Stroke, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A - OnabotulinumtoxinADrug
Also called BOTOX
100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.
Placebo (Saline)Drug
Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular OnabotulinumtoxinA | Experimental | Injection of Botulinum Toxin type A - onabotulinumtoxinA into specified shoulder muscles at second visit Receives: Drug: Botulinum Toxin Type A - OnabotulinumtoxinA |
| Intramuscular Placebo (Saline) | Active comparator | Injection of saline into specified shoulder muscles at Visit 2. Blind broken and subjects were offered study drug if initially in the placebo group, at week 12 Receives: Drug: Placebo (Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Rating From Baseline to Four Weeks
Change scores from patient ratings on the Visual Analogue Scale on 101 mm scale for worst pain, averaged over a week. Ratings performed at baseline and week four. Scale range 0-100 mm. Minimum value 0= No pain, Maximum value 100= worst pain Higher score indicates worse outcome
Measured: baseline and four weeks
Secondary outcomes (3)
Change in Disability Assessment Scale for Hygiene
Subject rating of scores on the Disability Assessment Scale Range 0-3, Minimum value 0= no disability, Maximum value 3= severe disability Higher Score indicates worse outcome
Measured: baseline and 4 weeks post injection
Time to Don a Pull Over Shirt
Measured: 2,4,12, and 16 weeks
Ability to Perform Hygiene Rating
Measured: 2,4,12, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startSep 2003
- Primary completionMar 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke Shoulder Pain and SpasticityStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Christina Marciniak, Shirley Ryan AbilityLab
- Investigators
- Christina Marciniak, MD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661089
- Sponsor's protocol ID
- 0335-006
- Status last verified
- Oct 2020
- First submitted
- 16 Apr 2008
- Last updated
- 13 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marciniak CM, Harvey RL, Gagnon CM, Duraski SA, Denby FA, McCarty S, Bravi LA, Polo KM, Fierstein KM. Does botulinum toxin type A decrease pain and lessen disability in hemiplegic survivors of stroke with shoulder pain and spasticity?: a randomized, double-blind, placebo-controlled trial. Am J Phys Med Rehabil. 2012 Dec;91(12):1007-19. doi: 10.1097/PHM.0b013e31826ecb02.
PubMed 23064478
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity"
- ClinicalTrials.gov ID
- NCT00661089
- Acronym / sponsor ID
- 0335-006
- Conditions
- Post-stroke Shoulder Pain and Spasticity
- Keywords
- stroke, shoulder pain, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Sep 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 6 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.
Detailed description
Subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. Following an initial screening visit involving a history and physical examination, subjects will be entered in to the study if they have significant spasticity of shoulder internal rotation/adduction associated with pain rated at least a 4 on the VAS for pain. Subjects will also be given a cognitive screening in which they will be asked to rate pain in hypothetical situations.
Shoulder pain is a frequent complication following hemiplegic stroke, and may result in further disability. Spasticity is also a complication following stroke . Botulinum toxin is used in the treatment of post-stroke spasticity and may also have pain modulating effects. Participants in this study will be asked to make total of 6 visits over a period of approximately 13 weeks. Eligible subjects will be randomized to 100 to 200 units of botulinum toxin type injected into the pectoralis major at the second visit. If there is significant spasticity for shoulder extension, subjects will also receive injections into the teres major. Subjects will be followed up with assessments of pain, functioning, active and passive range of motion and depression following the initial injection. At the 12 weeks post injection visit, the blinding will be broken and subjects initially injected with placebo will be injected with the active drug. This will be done to give all subjects an opportunity to receive the active drug, as well as to assess the effects of any differences with delayed treatment. All subjects will return 4 weeks later to repeat the same assessments above. Subjects will be called at one year post study enrollment for repeat pain ratings and for information regarding subsequent treatments.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular OnabotulinumtoxinA | Experimental | Drug: Botulinum Toxin Type A - OnabotulinumtoxinAInjection of Botulinum Toxin type A - onabotulinumtoxinA into specified shoulder muscles at second visit |
| Intramuscular Placebo (Saline) | Active comparator | Drug: Placebo (Saline)Injection of saline into specified shoulder muscles at Visit 2. Blind broken and subjects were offered study drug if initially in the placebo group, at week 12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post stroke greater than 2 months
- Shoulder pain despite PT/OT interventions
- Weight greater than 88 lbs
- Stable medically
- Spasticity
Key exclusion criteria (3 listed)
- Myasthenia gravis or other medical conditions that preclude use of botulinum toxin
- Pregnancy
- Infection or dermatologic conditions at the injection site
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 A - OnabotulinumtoxinAAlso: BOTOX100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors. | Drug | Intramuscular OnabotulinumtoxinA |
| Placebo (Saline)Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors. | Drug | Intramuscular Placebo (Saline) |
Primary outcome
Change in Pain Rating From Baseline to Four Weeks
Time frame: baseline and four weeks
Change scores from patient ratings on the Visual Analogue Scale on 101 mm scale for worst pain, averaged over a week. Ratings performed at baseline and week four. Scale range 0-100 mm. Minimum value 0= No pain, Maximum value 100= worst pain Higher score indicates worse outcome
3 secondary outcomes
Change in Disability Assessment Scale for Hygiene
Time frame: baseline and 4 weeks post injection
Time to Don a Pull Over Shirt
Time frame: 2,4,12, and 16 weeks
Ability to Perform Hygiene Rating
Time frame: 2,4,12, and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23064478Marciniak CM, Harvey RL, Gagnon CM, Duraski SA, Denby FA, McCarty S, Bravi LA, Polo KM, Fierstein KM. Does botulinum toxin type A decrease pain and lessen disability in hemiplegic survivors of stroke with shoulder pain and spasticity?: a randomized, double-blind, placebo-controlled trial. Am J Phys Med Rehabil. 2012 Dec;91(12):1007-19. doi: 10.1097/PHM.0b013e31826ecb02.
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.
Christina Marciniak, MD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A - OnabotulinumtoxinA in people with Post-stroke Shoulder Pain and Spasticity, run by Shirley Ryan AbilityLab at 1 site in United States.
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 5 inclusion and 3 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 13 Nov 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rating From Baseline to Four Weeks (time frame: baseline and four weeks). 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 NCT00661089, 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 13 Nov 2020.