Cervicobrachial NeuralgiaPhase 4NCT00241215
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
A Phase 4 study testing Botulinum toxin serotype A in people with Cervicobrachial Neuralgia and Myofascial Pain Syndromes, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Several studies have previously examined the use of botulinum toxin serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from: 1. inclusion of confounding conditions in the proband group, and 2. inability to identify predictors of response. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicobrachial Neuralgia, Myofascial Pain Syndromes
- What is being tested?
- Botulinum toxin serotype A
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Nov 2005
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-65 years.
- Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks
- Patients have numerical pain rating of 4 or greater
- Patients willing to adhere to a physical therapy program of 2-3 visits for myofascial release and also home stretching exercises for the length of the study
- Subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study.
- Women of child-bearing potential must be using a reliable means of contraception and have a negative urine pregnancy test prior to injection of BOTOX.
Who cannot join
- Subjects currently taking schedule II narcotics
- No new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study
- Pregnant or breastfeeding women
- Use of investigational drugs within one month of study
- Involvement in litigation surrounding neck pain
- Significant medical or psychiatric disease
- Patients with clinical depression (Beck's Depression score)
- Alcohol or drug abuse, in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Pain Management Center
Santa Monica, California, 90404
About this study
Official title: Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Several studies have previously examined the use of botulinum toxin serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:
- inclusion of confounding conditions in the proband group, and
- inability to identify predictors of response.
This study attempts to define the characteristics of responders to botulinum serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome).
Read the detailed description
Design: Single-center, double-blind, placebo-controlled, enriched trial.
Subjects will wash-out of their existing pain medications at least 2 weeks prior to baseline visit. At baseline, patients with a Numerical Pain Rating of 4 or greater will be injected with Botulinum Toxin Serotype A. At 14 weeks postinjection, those who at the 6 weeks post-injection visit had at least a 50% decrease in their pain outcome measures will be randomized into one of two treatment groups. Group 1 will receive a second BTX injection while group 2 will receive an injection of saline and both groups will be followed for an additional 6 weeks.
- Being tested
- Botulinum toxin serotype A
- Keywords
- Botulinum toxin serotype A, Cervicobrachial syndrome, Myofascial pain, Cervicothoracic myofascial pain, Propulsion, Postural abnormality
- Medical subject headings
- Brachial Plexus Neuritis, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin serotype ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating
Brief Pain Inventory
Neck Disability Index
Cervical range of motion
Number of trigger points
Postural exam
Secondary outcomes (2)
Pain Diary and medications use
Short Form (SF)-36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJun 2003
- Primary completionNov 2005
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 Cervicobrachial NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, F. Michael Ferrante, University of California, Los Angeles
- Investigators
- F. Michael Ferrante, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241215
- Sponsor's protocol ID
- UCLA#03-03-061-03A
- Status last verified
- Jun 2016
- First submitted
- 17 Oct 2005
- Last updated
- 21 Jun 2016
- Results posted
- No
Publications
Ferrante FM, Bearn L, Rothrock R, King L. Evidence against trigger point injection technique for the treatment of cervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology. 2005 Aug;103(2):377-83. doi: 10.1097/00000542-200508000-00021.
PubMed 16052120
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
- ClinicalTrials.gov ID
- NCT00241215
- Acronym / sponsor ID
- UCLA#03-03-061-03A
- Keywords
- Botulinum toxin serotype A, Cervicobrachial syndrome, Myofascial pain, Cervicothoracic myofascial pain, Propulsion, Postural abnormality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jun 2003
- Primary completion
- Nov 2005 (actual)
- First posted
- 18 Oct 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.
Several studies have previously examined the use of botulinum toxin serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:
- inclusion of confounding conditions in the proband group, and
- inability to identify predictors of response.
This study attempts to define the characteristics of responders to botulinum serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome).
Detailed description
Design: Single-center, double-blind, placebo-controlled, enriched trial.
Subjects will wash-out of their existing pain medications at least 2 weeks prior to baseline visit. At baseline, patients with a Numerical Pain Rating of 4 or greater will be injected with Botulinum Toxin Serotype A. At 14 weeks postinjection, those who at the 6 weeks post-injection visit had at least a 50% decrease in their pain outcome measures will be randomized into one of two treatment groups. Group 1 will receive a second BTX injection while group 2 will receive an injection of saline and both groups will be followed for an additional 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18-65 years.
- Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks
- Patients have numerical pain rating of 4 or greater
- Patients willing to adhere to a physical therapy program of 2-3 visits for myofascial release and also home stretching exercises for the length of the study
- Subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study.
Key exclusion criteria (8 listed)
- Subjects currently taking schedule II narcotics
- No new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study
- Pregnant or breastfeeding women
- Use of investigational drugs within one month of study
- Involvement in litigation surrounding neck 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 |
|---|---|---|
| Botulinum toxin serotype A | Drug | – |
Primary outcome
Numerical pain rating
Brief Pain Inventory
Neck Disability Index
Cervical range of motion
Number of trigger points
Postural exam
2 secondary outcomes
Pain Diary and medications use
Short Form (SF)-36
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 Jun 2016.
- Results publication: PubMed 16052120Ferrante FM, Bearn L, Rothrock R, King L. Evidence against trigger point injection technique for the treatment of cervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology. 2005 Aug;103(2):377-83. doi: 10.1097/00000542-200508000-00021.
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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.
F. Michael Ferrante, MD principal investigator
University of California, Los Angeles
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 Botulinum toxin serotype A in people with Cervicobrachial Neuralgia and Myofascial Pain Syndromes, run by University of California, Los Angeles 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 21 Jun 2016. 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 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?
Numerical pain rating. The study lists 6 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 NCT00241215, 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 21 Jun 2016.