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Neurotoxin

botulinum toxin injected for Neck Pain

Phase 1
Waitlist Available
Led By Hajime A Tokuno, MD
Research Sponsored by VA Connecticut Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study 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.

Eligible Conditions
  • Neck Pain
  • Lower Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lumbar Pain Rating Scale
Secondary outcome measures
Cervical and Lumbar Range of Motion
Oswestry Lumbar Disability Scale
VAS score
+2 more

Side effects data

From 2018 Phase 3 trial • 351 Patients • NCT02002884
6%
Nasopharyngitis
2%
Bronchitis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
MP Low Dose Group
MP Mid Dose Group
MP High Dose Group
OLEX (3 Injections)

Trial Design

1Treatment groups
Experimental Treatment
Group I: botulinum toxin injectedExperimental Treatment1 Intervention
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)

Find a Location

Who is running the clinical trial?

VA Connecticut Healthcare SystemLead Sponsor
81 Previous Clinical Trials
6,650 Total Patients Enrolled
Hajime A Tokuno, MDPrincipal InvestigatorVA Connecticut

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain
2016. "New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02008136.
All > Chronic Back Pain > Back Pain
~7 spots leftby Apr 2025
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