New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain
1 other identifier
interventional
60
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 7, 2017
December 1, 2017
2.4 years
November 27, 2013
December 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lumbar Pain Rating Scale
This is an 8 point rating scale for low back pain
3 months
Secondary Outcomes (5)
digital thermography
3 months
VAS score
3 months
Oswestry Lumbar Disability Scale
3 months
Cervical and Lumbar Range of Motion
3 months
surface EMG (sEMG)
3 months
Study Arms (1)
botulinum toxin injected
EXPERIMENTALBecause 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)
Interventions
Eligibility Criteria
You may qualify if:
- Veterans with chronic neck or back pain for at least 6 months.
- No botulinum toxin injections in the last 6 months.
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Connecticut Healthcare Services
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hajime A Tokuno, MD
VA Connecticut
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 11, 2013
Study Start
March 1, 2016
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
December 7, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share