CervicalgiaPhase 1NCT02008136
New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain
A Phase 1 study testing Botulinum Toxins in people with Cervicalgia and Low Back Pain, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
This protocol is a prospective, open label, pilot study examining the utility of three established pain questionnaires (the Visual Analogue Scale (VAS), Neck Disability Index (NDI), the Oswestry Low Back Pain Questionnaire and two novel pain scale devised by the PI) as well as their relationship to three novel… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cervicalgia, Low Back Pain
- What is being tested?
- Botulinum Toxins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- Phase
- Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with chronic neck or back pain for at least 6 months.
- No botulinum toxin injections in the last 6 months.
Who cannot join
- Non-muscular neck or back pain
- Signs or symptoms of nerve root or spinal cord injury
- History of adverse events associated with botulinum toxin injections
- Major neurological disorder
- recent stroke
- myasthenia gravis
Show all 14Show fewer
- muscular dystrophy
- myotonic dystrophy
- amyotrophic lateral sclerosis
- Unstable cardiac or pulmonary disease
- Pregnancy
- Severe psychiatric illness, dementia or delirium
- Excessive obesity
- Severe spinal curvature (i.e. severe scoliosis or severe kyphosis)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Connecticut Healthcare Services
West Haven, Connecticut, 06516
About this study
This protocol is a prospective, open label, pilot study examining the utility of three established pain questionnaires (the Visual Analogue Scale (VAS), Neck Disability Index (NDI), the Oswestry Low Back Pain Questionnaire and two novel pain scale devised by the PI) as well as their relationship to three novel quantitative tools to measure the effect of botulinum toxin injections for neck pain and back pain. The three novel methods for measuring neurotoxin effect are: muscle twitch patterns using surface electromyography (sEMG), cervical and lumbar range of motion using a neck and low back inclinometer, and skin surface temperature readings using an infrared imaging camera.
Read the detailed description
Botulinum toxins are a well-established group of neurotoxins that have a wide variety of FDA approved clinical uses including muscle relaxation, headache prevention and bladder control. Despite the abundance of anecdotal evidence supporting their use in pain management, double blind placebo control studies examining the efficacy of botulinum toxins in the treatment of chronic neck and back pain have reported mixed findings. Several smaller studies have shown significantly positive outcomes while other studies have found no efficacy of neurotoxins compared to placebo. The existing literature reveals that most negative outcome studies were based on the Visual Analogue Scale, which is a purely subjective measure. We propose a more objective set of measures that might better reflect patients' deficits and levels of discomfort.
Our proposal is a prospective, open-label, pilot study that will examine chronic neck and back pain among veterans. Our primary specific aim is to test three novel methods for evaluating clinical deficits in patients who have chronic neck and back pain: electromyographical (EMG) activity (primary outcome) and cervical/lumbar range of motion (CROM \& LROM) (primary outcome) as well as skin surface temperature (thermography) (secondary outcome). Our hypothesis is that most patients with chronic neck and back pain significantly from sustained muscle spasms. As a result, patients may exhibit surplus EMG activity in affected areas due to spontaneous muscle twitch. And consequently, they may show signs of decreased range of motion due to increased muscle tone. They may also experience a rise in skin surface temperature due to excess heat production from sustained muscle contraction. We will measure these three phenomena using three different biophysical measurement tools. Electromyographic data will be collected with a surface EMG device, and cervical and lumbar range of motion with a gravity inclinometer. Skin surface temperature will be assessed with a medical grade digital thermography camera.
The second specific aim of this study is to examine the efficacy of botulinum toxins in reversing the anomalies in the above measured parameters: to reduce excessive electromyographic activity, to increase range of motion in cervical and lumbar joints and to reduce elevated skin surface temperature. We will measure outcomes of 60 study subjects (30 for neck pain and 30 for low back pain) who will all be treated once with botulinum toxins and then followed up at 1 month, 2 months and 3 months. We will also correlate our findings with the more commonly used pain and function scales: the Visual Analogue Scale, Neck Disability Index and the Oswestry Low Back Pain Scale.
- Conditions
- Cervicalgia, Low Back Pain
- Being tested
- Botulinum Toxins
- Keywords
- myofascial pain, muscle spasm, botulinum toxin, cervicalgia, lumbago, low back pain
- Medical subject headings
- Neck Pain, Low Back Pain, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum ToxinsDrug
Also called Botox, Myobloc
intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin injected | Experimental | Because this is an open label study, all subjects will receive one of two botulinum toxins based on their symptoms. Those will cervicalgia will receive Botox (botulinum toxin A) and those with lumbago or low back pain will receive Myobloc (botulinum toxin B) Receives: Drug: Botulinum Toxins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Pain Rating Scale
This is an 8 point rating scale for low back pain
Measured: 3 months
Secondary outcomes (5)
digital thermography
measurement of heat production from discrete muscle groups in the neck and low back using a medical grade infrared thermography camera
Measured: 3 months
VAS score
Visual analogue scale
Measured: 3 months
Oswestry Lumbar Disability Scale
A scoring system that assesses functional loss due to neck injury
Measured: 3 months
Cervical and Lumbar Range of Motion
Measurement of spine rotation in x, y and z axes
Measured: 3 months
surface EMG (sEMG)
non-invasive electrophysiological measurement of spontaneous muscle activity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startMar 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalgiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hajime A Tokuno, MD, Principal investigator, VA Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008136
- Sponsor's protocol ID
- 01769
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2013
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain
- ClinicalTrials.gov ID
- NCT02008136
- Acronym / sponsor ID
- 01769
- Conditions
- Cervicalgia, Low Back Pain
- Keywords
- myofascial pain, muscle spasm, botulinum toxin, cervicalgia, lumbago, low back pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Mar 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Dec 2013 (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.
This protocol is a prospective, open label, pilot study examining the utility of three established pain questionnaires (the Visual Analogue Scale (VAS), Neck Disability Index (NDI), the Oswestry Low Back Pain Questionnaire and two novel pain scale devised by the PI) as well as their relationship to three novel quantitative tools to measure the effect of botulinum toxin injections for neck pain and back pain. The three novel methods for measuring neurotoxin effect are: muscle twitch patterns using surface electromyography (sEMG), cervical and lumbar range of motion using a neck and low back inclinometer, and skin surface temperature readings using an infrared imaging camera.
Detailed description
Botulinum toxins are a well-established group of neurotoxins that have a wide variety of FDA approved clinical uses including muscle relaxation, headache prevention and bladder control. Despite the abundance of anecdotal evidence supporting their use in pain management, double blind placebo control studies examining the efficacy of botulinum toxins in the treatment of chronic neck and back pain have reported mixed findings. Several smaller studies have shown significantly positive outcomes while other studies have found no efficacy of neurotoxins compared to placebo. The existing literature reveals that most negative outcome studies were based on the Visual Analogue Scale, which is a purely subjective measure. We propose a more objective set of measures that might better reflect patients' deficits and levels of discomfort.
Our proposal is a prospective, open-label, pilot study that will examine chronic neck and back pain among veterans. Our primary specific aim is to test three novel methods for evaluating clinical deficits in patients who have chronic neck and back pain: electromyographical (EMG) activity (primary outcome) and cervical/lumbar range of motion (CROM \& LROM) (primary outcome) as well as skin surface temperature (thermography) (secondary outcome). Our hypothesis is that most patients with chronic neck and back pain significantly from sustained muscle spasms. As a result, patients may exhibit surplus EMG activity in affected areas due to spontaneous muscle twitch. And consequently, they may show signs of decreased range of motion due to increased muscle tone. They may also experience a rise in skin surface temperature due to excess heat production from sustained muscle contraction. We will measure these three phenomena using three different biophysical measurement tools. Electromyographic data will be collected with a surface EMG device, and cervical and lumbar range of motion with a gravity inclinometer. Skin surface temperature will be assessed with a medical grade digital thermography camera.
The second specific aim of this study is to examine the efficacy of botulinum toxins in reversing the anomalies in the above measured parameters: to reduce excessive electromyographic activity, to increase range of motion in cervical and lumbar joints and to reduce elevated skin surface temperature. We will measure outcomes of 60 study subjects (30 for neck pain and 30 for low back pain) who will all be treated once with botulinum toxins and then followed up at 1 month, 2 months and 3 months. We will also correlate our findings with the more commonly used pain and function scales: the Visual Analogue Scale, Neck Disability Index and the Oswestry Low Back Pain Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin injected | Experimental | Drug: Botulinum ToxinsBecause this is an open label study, all subjects will receive one of two botulinum toxins based on their symptoms. Those will cervicalgia will receive Botox (botulinum toxin A) and those with lumbago or low back pain will receive Myobloc (botulinum toxin B) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans with chronic neck or back pain for at least 6 months.
- No botulinum toxin injections in the last 6 months.
Key exclusion criteria (14 listed)
- Non-muscular neck or back pain
- Signs or symptoms of nerve root or spinal cord injury
- History of adverse events associated with botulinum toxin injections
- Major neurological disorder
- Unstable cardiac or pulmonary disease
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 ToxinsAlso: Botox, Myoblocintramuscular injections | Drug | botulinum toxin injected |
Primary outcome
Lumbar Pain Rating Scale
Time frame: 3 months
This is an 8 point rating scale for low back pain
5 secondary outcomes
digital thermography
Time frame: 3 months
VAS score
Time frame: 3 months
Oswestry Lumbar Disability Scale
Time frame: 3 months
Cervical and Lumbar Range of Motion
Time frame: 3 months
surface EMG (sEMG)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Hajime A Tokuno, MD principal investigator
VA Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum Toxins in people with Cervicalgia and Low Back Pain, run by VA Connecticut Healthcare System 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 2 inclusion and 14 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 7 Dec 2017. 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 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.
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 Hajime A Tokuno, MD (203-937-4724, hajime.tokuno@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Pain Rating Scale (time frame: 3 months). 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 7 Dec 2017.