Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS)Phase 1/2NCT00178945
Botulinum Toxin Type A (Botox) for the Treatment of Cervical Dystonia and Upper Thoracic Muscular Pain
A Phase 1/2 study testing Botulinum Toxin Type A in people with Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS) and Cervical Dystonia, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of injections of Botox (botulinum toxin type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients with cervical dystonia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS), Cervical Dystonia
- What is being tested?
- Botulinum Toxin Type A
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Mar 2006
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient, male and female subjects, of any race, between 18 years of age and older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Screening/Baseline Visit. (A female is considered of childbearing potential unless she is postmenopausal or without a uterus and/or both ovaries.)
- Subjects suffering from cervicothoracic muscle pain with or without cervical dystonia. The pain must be of at least 3 months duration and characterized by a numerical pain rating score of at least 5 on the pain subscale of the TWSTR scale.
- Subjects who are able to understand the requirements of the study and sign an Informed Consent Form.
Who cannot join
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control (OCP or barrier).
- Subjects who have had standard trigger point injections with local anesthetics in the last 3 months.
- Subjects who have had chiropractic manipulation of the neck or upper thoracic region in the last 3 months or plan on having such manipulations during the study.
- Subjects, who by clinical evaluation and / or MRI study, are considered to have symptomatic cervical and/or thoracic disc pathology as primary etiology of their pain.
- Subjects whose cervical spine ROM is restricted in the setting of arthritic conditions (advanced osteoporosis, degenerative arthritis, ankylosing spondylitis).
- Significant medical or psychiatric comorbid disease, as deemed by the investigators
Show all 15Show fewer
- Litigation involving the existence or cause for neck pain and/or headache
- Pending disability assessment
- Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
- Subjects currently using aminoglycoside antibiotics or agents that interfere with neuromuscular function.
- Subjects with profound atrophy or excessive weakness of the muscles in the target area(s) of injection.
- Subjects with an infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery).
- Subjects with an allergy or sensitivity to any component of the test medication.
- Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
- Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Department of Neurology
Nashville, Tennessee, 37212
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Botulinum Toxin Type A (Botox) for the Treatment of Pain Associated With Cervical Dystonia and Refractory Cervicothoracic Myofascial Pain Syndrome
The purpose of this study is to investigate the use of injections of Botox (botulinum toxin type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary movements of the neck that are often painful. In this study, the response from Botox in patients with neck pain not associated with cervical dystonia will be compared to the pain response in patients with cervical dystonia.
Read the detailed description
Cervical dystonia (CD) is a condition characterized by involuntary movements of the neck. Generally these movements are rotational and are frequently associated with significant pain. Treatment of CD with oral medications is usually unsuccessful and the current treatment of choice for the majority of patients consists of periodic injections of botulinum toxin into the offending muscles. Resistant cases are considered candidates for selective surgical denervation procedures.
Botulinum toxin type A (Botox®) is a FDA approved treatment for CD. Botox® has been safely used to treat CD in our clinic since 1989. In controlled trials, Botox® significantly improved pain in patients with CD.
Cervico-thoracic pain syndromes not associated with dystonia (refractory cervicothoracic myofascial pain syndrome or CMPS) is a chronic regional pain syndrome. It is a common component in acute and chronic pain syndromes, occurring in up to 14% of the U.S. population. This pain is often resistant to treatment and is characterized by a series of tender trigger points. These are often injected with local anesthetics that provide temporary relief of pain in some patients. Recent uncontrolled trials have suggested that Botox® may be helpful in patients with CMPS. Most attempts to use Botox® to treat these Patients have utilized smaller doses of Botox® than those used typically to treat CD. Also, most studies have used Botox® injection into tender trigger points rather than into the belly of the muscle as is commonly done to treat CD.
In this study we will use doses of Botox® that are typically used to treat CD. Injections of Botox® will be guided by EMG to determine areas of involuntarily firing muscle rather than solely into tender trigger points. The results in patients with CMPS will be compared to the pain relief experienced with those with CD. It is hoped that this trial will provide pilot data for planning a larger safety and efficacy trial of Botox® for chronic cervico-thoracic pain not associated with CD.
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Pain Subscale of the TWSTRS
Secondary outcomes (2)
Daily pain diary for 14 days post-injection
Safety profile at study exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas L Davis, Vanderbilt University
- Investigators
- Thomas L Davis, MD, Principal investigator, Vanderbilt University Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178945
- Sponsor's protocol ID
- 030797
- Status last verified
- Aug 2007
- First submitted
- 12 Sep 2005
- Last updated
- 1 Jun 2016
- Results posted
- No
Publications
Comella CL, Buchman AS, Tanner CM, Brown-Toms NC, Goetz CG. Botulinum toxin injection for spasmodic torticollis: increased magnitude of benefit with electromyographic assistance. Neurology. 1992 Apr;42(4):878-82. doi: 10.1212/wnl.42.4.878.
PubMed 1565246Freund BJ, Schwartz M. Treatment of whiplash associated neck pain [corrected] with botulinum toxin-A: a pilot study. J Rheumatol. 2000 Feb;27(2):481-4.
PubMed 10685817Gobel H, Heinze A, Heinze-Kuhn K, Austermann K. Botulinum toxin A in the treatment of headache syndromes and pericranial pain syndromes. Pain. 2001 Apr;91(3):195-199. doi: 10.1016/S0304-3959(01)00292-5. No abstract available.
PubMed 11275374Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain. 2000 Mar;85(1-2):101-5. doi: 10.1016/s0304-3959(99)00264-x.
PubMed 10692608Wheeler AH, Goolkasian P, Gretz SS. A randomized, double-blind, prospective pilot study of botulinum toxin injection for refractory, unilateral, cervicothoracic, paraspinal, myofascial pain syndrome. Spine (Phila Pa 1976). 1998 Aug 1;23(15):1662-6; discussion 1667. doi: 10.1097/00007632-199808010-00009.
PubMed 9704373Wheeler AH, Goolkasian P, Gretz SS. Botulinum toxin A for the treatment of chronic neck pain. Pain. 2001 Dec;94(3):255-260. doi: 10.1016/S0304-3959(01)00358-X.
PubMed 11731062Botox(R) (Botulinum Toxin Type A) Purified Neurotoxin Complex. Package Insert.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Botulinum Toxin Type A (Botox) for the Treatment of Pain Associated With Cervical Dystonia and Refractory Cervicothoracic Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT00178945
- Acronym / sponsor ID
- 030797
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Mar 2006
- First posted
- 15 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 investigate the use of injections of Botox (botulinum toxin type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary movements of the neck that are often painful. In this study, the response from Botox in patients with neck pain not associated with cervical dystonia will be compared to the pain response in patients with cervical dystonia.
Detailed description
Cervical dystonia (CD) is a condition characterized by involuntary movements of the neck. Generally these movements are rotational and are frequently associated with significant pain. Treatment of CD with oral medications is usually unsuccessful and the current treatment of choice for the majority of patients consists of periodic injections of botulinum toxin into the offending muscles. Resistant cases are considered candidates for selective surgical denervation procedures.
Botulinum toxin type A (Botox®) is a FDA approved treatment for CD. Botox® has been safely used to treat CD in our clinic since 1989. In controlled trials, Botox® significantly improved pain in patients with CD.
Cervico-thoracic pain syndromes not associated with dystonia (refractory cervicothoracic myofascial pain syndrome or CMPS) is a chronic regional pain syndrome. It is a common component in acute and chronic pain syndromes, occurring in up to 14% of the U.S. population. This pain is often resistant to treatment and is characterized by a series of tender trigger points. These are often injected with local anesthetics that provide temporary relief of pain in some patients. Recent uncontrolled trials have suggested that Botox® may be helpful in patients with CMPS. Most attempts to use Botox® to treat these Patients have utilized smaller doses of Botox® than those used typically to treat CD. Also, most studies have used Botox® injection into tender trigger points rather than into the belly of the muscle as is commonly done to treat CD.
In this study we will use doses of Botox® that are typically used to treat CD. Injections of Botox® will be guided by EMG to determine areas of involuntarily firing muscle rather than solely into tender trigger points. The results in patients with CMPS will be compared to the pain relief experienced with those with CD. It is hoped that this trial will provide pilot data for planning a larger safety and efficacy trial of Botox® for chronic cervico-thoracic pain not associated with CD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatient, male and female subjects, of any race, between 18 years of age and older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Screening/Baseline Visit. (A female is considered of childbearing potential unless she is postmenopausal or without a uterus and/or both ovaries.)
- Subjects suffering from cervicothoracic muscle pain with or without cervical dystonia. The pain must be of at least 3 months duration and characterized by a numerical pain rating score of at least 5 on the pain subscale of the TWSTR scale.
- Subjects who are able to understand the requirements of the study and sign an Informed Consent Form.
Key exclusion criteria (15 listed)
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control (OCP or barrier).
- Subjects who have had standard trigger point injections with local anesthetics in the last 3 months.
- Subjects who have had chiropractic manipulation of the neck or upper thoracic region in the last 3 months or plan on having such manipulations during the study.
- Subjects, who by clinical evaluation and / or MRI study, are considered to have symptomatic cervical and/or thoracic disc pathology as primary etiology of their pain.
- Subjects whose cervical spine ROM is restricted in the setting of arthritic conditions (advanced osteoporosis, degenerative arthritis, ankylosing spondylitis).
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 | Drug | – |
Primary outcome
Score on the Pain Subscale of the TWSTRS
2 secondary outcomes
Daily pain diary for 14 days post-injection
Safety profile at study exit
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 1 Jun 2016.
- Background: PubMed 1565246Comella CL, Buchman AS, Tanner CM, Brown-Toms NC, Goetz CG. Botulinum toxin injection for spasmodic torticollis: increased magnitude of benefit with electromyographic assistance. Neurology. 1992 Apr;42(4):878-82. doi: 10.1212/wnl.42.4.878.
- Background: PubMed 10685817Freund BJ, Schwartz M. Treatment of whiplash associated neck pain [corrected] with botulinum toxin-A: a pilot study. J Rheumatol. 2000 Feb;27(2):481-4.
- Background: PubMed 11275374Gobel H, Heinze A, Heinze-Kuhn K, Austermann K. Botulinum toxin A in the treatment of headache syndromes and pericranial pain syndromes. Pain. 2001 Apr;91(3):195-199. doi: 10.1016/S0304-3959(01)00292-5. No abstract available.
- Background: PubMed 10692608Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain. 2000 Mar;85(1-2):101-5. doi: 10.1016/s0304-3959(99)00264-x.
- Background: PubMed 9704373Wheeler AH, Goolkasian P, Gretz SS. A randomized, double-blind, prospective pilot study of botulinum toxin injection for refractory, unilateral, cervicothoracic, paraspinal, myofascial pain syndrome. Spine (Phila Pa 1976). 1998 Aug 1;23(15):1662-6; discussion 1667. doi: 10.1097/00007632-199808010-00009.
- Background: PubMed 11731062Wheeler AH, Goolkasian P, Gretz SS. Botulinum toxin A for the treatment of chronic neck pain. Pain. 2001 Dec;94(3):255-260. doi: 10.1016/S0304-3959(01)00358-X.
- BackgroundBotox(R) (Botulinum Toxin Type A) Purified Neurotoxin Complex. Package Insert.
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.
Thomas L Davis, MD principal investigator
Vanderbilt University Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Botulinum Toxin Type A in people with Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS) and Cervical Dystonia, run by Vanderbilt 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 3 inclusion and 15 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 1 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Score on the Pain Subscale of the TWSTRS. 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 NCT00178945, which also lists 7 linked publications.
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 1 Jun 2016.