ArthritisPhase 3NCT00211718
Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain
A Phase 3 study testing intra-articular botulinum toxin type a in people with Arthritis and Shoulder Pain, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Shoulder Pain
- What is being tested?
- intra-articular botulinum toxin type a
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2007
- Phase
- Phase 3
- 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
- • Male or female subjects, 18 years of age or older.
- Written informed consent and written authorization for use or release of health and research study information have been obtained.
- Subject has chronic Shoulder joint pain for more than 1 year.
- Subject has pain >4.5 on numerical rating scale of 0 to 10.
- Ability to follow study instructions and likely to complete all required visits.
- Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable)
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- Patients previously treated with intra-articular corticosteroid or viscosupplementation injections.
- Patients with rheumatoid arthritis must have failed therapy with standard DMARDs (disease modifying anti-rheumatic drugs) and anti-TNF agents unless they have a contraindication to TNF blockers.
- Patients who were considered not to be candidates for Shoulder joint replacement because of young age, abnormalities in periarticular tissues or because of co-morbid conditions.
- Must be ambulatory and able to perform sit to stand.
Who cannot join
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- Any medical condition that may put the subject at increased risk with exposure to botulinum neurotoxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, any other disorder that might interfere with neuromuscular function or the presence of severe peripheral neuropathy.
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Known allergy or sensitivity to any of the components in the study medication.
- Evidence of recent alcohol or drug abuse.
- Infection at injection site or systemic infection (postpone study entry until one week following recovery.
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- Known, uncontrolled serious systemic disease and/or life expectancy less than 12 months.
- Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Patients whose pain is rated as less than 4.5 on a 10 point Numerical Pain Rating scale at the screening visit
- Patients on coumadin or heparin because of increased risk of bleeding in the joint
- Serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VAMC
Minneapolis, Minnesota, 55417
Maren l Mahowald, MD, 612-467-4190, mahow001@umn.edu
Jasvinder A Singh, MD MPH, 6124674190, Jasvinder.Singh@va.gov
About this study
Official title: Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial
The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.
Read the detailed description
Chronic shoulder pain unresponsive to oral medications and intra-articular corticosteroids is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter).
Comparisons: Intra-articular injection of botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then saline).
- Conditions
- Arthritis, Shoulder Pain
- Being tested
- intra-articular botulinum toxin type a
- Keywords
- shoulder pain, arthritis, intra-articular botulinum toxin a, joint pain
- Medical subject headings
- Arthritis, Shoulder Pain, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular botulinum toxin type aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
: Primary Outcomes:
Change in Pain Score
Change in Joint Function
Patient Global Assessment
Secondary outcomes (7)
Secondary Outcomes:
Pain Relief
Change in Health Status Quality of Life-SF36
Change in Disease specific Health Related QOL-WOOS
Function improvement - Range of Motion, SPADI, Simple Shoulder tes
Physican Assessment of Pain and Global Assessment of Improvement
Safety Measure,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Allergan, Center for Veterans Research and Education
- Investigators
- Maren L Mahowald, MD, Principal investigator, Minneapolis VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211718
- Sponsor's protocol ID
- IRB Protocol Number 03404B
- Status last verified
- Aug 2005
- First submitted
- 14 Sep 2005
- Last updated
- 3 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00211718
- Acronym / sponsor ID
- IRB Protocol Number 03404B
- Conditions
- Arthritis, Shoulder Pain
- Keywords
- shoulder pain, arthritis, intra-articular botulinum toxin a, joint pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Allergan, Center for Veterans Research and Education
- Study start
- Jul 2004
- Study completion
- Jun 2007
- First posted
- 21 Sep 2005 (estimated)
- 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.
The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.
Detailed description
Chronic shoulder pain unresponsive to oral medications and intra-articular corticosteroids is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter).
Comparisons: Intra-articular injection of botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then saline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Male or female subjects, 18 years of age or older.
Key exclusion criteria (12 listed)
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- Any medical condition that may put the subject at increased risk with exposure to botulinum neurotoxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, any other disorder that might interfere with neuromuscular function or the presence of severe peripheral neuropathy.
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Known allergy or sensitivity to any of the components in the study medication.
- Evidence of recent alcohol or drug abuse.
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 |
|---|---|---|
| intra-articular botulinum toxin type a | Drug | – |
Primary outcome
: Primary Outcomes:
Change in Pain Score
Change in Joint Function
Patient Global Assessment
7 secondary outcomes
Secondary Outcomes:
Pain Relief
Change in Health Status Quality of Life-SF36
Change in Disease specific Health Related QOL-WOOS
Function improvement - Range of Motion, SPADI, Simple Shoulder tes
Physican Assessment of Pain and Global Assessment of Improvement
Safety Measure,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2005.
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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.
Maren L Mahowald, MD principal investigator
Minneapolis VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intra-articular botulinum toxin type a in people with Arthritis and Shoulder Pain, run by Minneapolis Veterans Affairs Medical Center 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 10 inclusion and 12 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 3 Nov 2005. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Maren L Mahowald, MD (6124674190, mahow001@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Primary Outcomes:. The study lists 4 primary outcomes in all. 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 3 Nov 2005.