Post Traumatic StiffnessNCT01129583
Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness
A study testing Botulinum Toxin Type A and Saline in people with Post Traumatic Stiffness, run by Columbia University at 1 site in United States.
Trial summary
This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stiffness
- What is being tested?
- Botulinum Toxin Type A and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to May 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
- Capable of providing informed consent
- 18 years old and older
- Elbow fractures that require operative intervention including:
- Supracondylar distal humerus fractures
- Intra-articular distal humerus fractures
- Proximal ulna and radius fractures
Who cannot join
- Patients less than 18 years old
- Injuries that do not normally require surgical repair
- Patients with underlying spasticity
- Patients with burns about the elbow
- Patients with extensive soft tissue injuries of the elbow
- Patients with head or spinal cord injuries
- Myasthenia gravis, Eaton-Lambert, amyotrophic lateral sclerosis or any other disease that interferes with neuromuscular function
- Use of aminoglycoside antibiotics or other drug therapies that interfere with neuromuscular function
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Intraoperative Injection of Botulinum Toxin A (Botox) for the Prevention of Post-Traumatic Elbow Stiffness: A Randomized Double Blind Placebo Controlled Study
This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function.
Read the detailed description
This is a randomized double blind placebo controlled prospective study in which botulinum toxin A (Botox®) or normal saline will be intraoperatively injected into the muscles surrounding the elbow following the surgical treatment of an elbow fracture or elbow fracture dislocation.
Eligible patients will be identified by the Principal Investigator in his practice or by fellows and residents from the clinic population and emergency department admissions. After providing informed consent, all subjects will undergo a baseline examination that will include a medical and orthopaedic history, physical examination, and radiographs. The surgical procedure itself will not differ from the standard care for elbow fractures. The only difference is injection of Botox® or normal saline into the muscles of the injured arm. Subjects will undergo post-operative evaluation at various intervals for up to two years. The study and control group will be compared to each other and to contralateral arms in regards to elbow range of motion, patient questionnaire scores (DASH) and an observer-based elbow scoring system (Broberg and Morrey).
Traumatic injury to the elbow resulting in a fracture or fracture/dislocation of the elbow often leads to a stiff elbow with limited function. Posttraumatic elbow stiffness is a common problem that is difficult to manage. The best way to decrease the morbidity is through prevention. An intraoperative injection of Botox® has been effective in treating upper limb spasticity disorders and may prevent the development of elbow stiffness, and decrease the need for future surgery to regain motion.
- Conditions
- Post Traumatic Stiffness
- Being tested
- Botulinum Toxin Type A, Saline
- Keywords
- Botulinum Toxin, Elbow Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox®
Injection into the biceps brachii and brachialis immediately following the initial fracture surgery
SalineDrug
Injection into the biceps brachii and brachialis immediately following the initial fracture surgery
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin | Experimental | 100 U injected into biceps, 100 U into brachialis Receives: Drug: Botulinum Toxin Type A |
| Saline | Placebo comparator | 100 U injected into biceps, 100 U into brachialis Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb.
The DASH is scored in two components: the disability/symptom questions (30 items, scored 1-5) and the optional high performance sport/music or work section (4 items, scored 1-5). The DASH disability/symptom score (0-100) is calculated by averaging all the scores, subtracting one and multiplying by 25. A score of 0 represents "no disability", while 100 represents "maximum possible disability".
Measured: 1 year post-op
Secondary outcomes (2)
Elbow Range of Motion
Elbow flexion/extension active range of motion was assessed with the use of a standard goniometer with the center placed over the lateral epicondyle and the arms aligned with the long axis of the humerus and ulna, respectively. Full extension (arm completely straight) is defined as 0 degrees, and peak flexion is measured as the angle formed by the arm and forearm compared to a full straight arm.
Measured: 3 months post-op
Broberg Morrey Composite Elbow Function Score
Composite elbow function store that takes into account range of motion, stability, strength, and pain. Score ranges from 0 (worse possible function) to 100 (best possible function).
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startNov 2003
- Primary completionSep 2009
- Study completionMay 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.
- Other trials for Post Traumatic StiffnessStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Melvin Rosenwasser, Columbia University
- Investigators
- Melvin Rosenwasser, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129583
- Sponsor's protocol ID
- AAAA8392
- Status last verified
- Mar 2015
- First submitted
- 21 May 2010
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Injection of Botulinum Toxin A (Botox) for the Prevention of Post-Traumatic Elbow Stiffness: A Randomized Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01129583
- Acronym / sponsor ID
- AAAA8392
- Conditions
- Post Traumatic Stiffness
- Keywords
- Botulinum Toxin, Elbow Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Nov 2003
- Primary completion
- Sep 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Posted 2 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function.
Detailed description
This is a randomized double blind placebo controlled prospective study in which botulinum toxin A (Botox®) or normal saline will be intraoperatively injected into the muscles surrounding the elbow following the surgical treatment of an elbow fracture or elbow fracture dislocation.
Eligible patients will be identified by the Principal Investigator in his practice or by fellows and residents from the clinic population and emergency department admissions. After providing informed consent, all subjects will undergo a baseline examination that will include a medical and orthopaedic history, physical examination, and radiographs. The surgical procedure itself will not differ from the standard care for elbow fractures. The only difference is injection of Botox® or normal saline into the muscles of the injured arm. Subjects will undergo post-operative evaluation at various intervals for up to two years. The study and control group will be compared to each other and to contralateral arms in regards to elbow range of motion, patient questionnaire scores (DASH) and an observer-based elbow scoring system (Broberg and Morrey).
Traumatic injury to the elbow resulting in a fracture or fracture/dislocation of the elbow often leads to a stiff elbow with limited function. Posttraumatic elbow stiffness is a common problem that is difficult to manage. The best way to decrease the morbidity is through prevention. An intraoperative injection of Botox® has been effective in treating upper limb spasticity disorders and may prevent the development of elbow stiffness, and decrease the need for future surgery to regain motion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin | Experimental | Drug: Botulinum Toxin Type A100 U injected into biceps, 100 U into brachialis |
| Saline | Placebo comparator | Drug: Saline100 U injected into biceps, 100 U into brachialis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Capable of providing informed consent
- 18 years old and older
- Elbow fractures that require operative intervention including:
- Supracondylar distal humerus fractures
- Intra-articular distal humerus fractures
Key exclusion criteria (8 listed)
- Patients less than 18 years old
- Injuries that do not normally require surgical repair
- Patients with underlying spasticity
- Patients with burns about the elbow
- Patients with extensive soft tissue injuries of the elbow
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®Injection into the biceps brachii and brachialis immediately following the initial fracture surgery | Drug | Botulinum Toxin |
| SalineInjection into the biceps brachii and brachialis immediately following the initial fracture surgery | Drug | Saline |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time frame: 1 year post-op
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb. The DASH is scored in two components: the disability/symptom questions (30 items, scored 1-5) and the optional high performance sport/music or work section (4 items, scored 1-5). The DASH disability/symptom score (0-100) is calculated by averaging all the scores, subtracting one and multiplying by 25. A score of 0 represents "no disability", while 100 represents "maximum possible disability".
2 secondary outcomes
Elbow Range of Motion
Time frame: 3 months post-op
Broberg Morrey Composite Elbow Function Score
Time frame: 6 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melvin Rosenwasser, MD principal investigator
Columbia University
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 and Saline in people with Post Traumatic Stiffness, run by Columbia University 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 6 inclusion and 8 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 27 Mar 2015. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2011). 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?
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire (time frame: 1 year post-op). 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 27 Mar 2015.