drugset / Trial / NCT02008136

New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain

NCT02008136

Phase 1 Unknown 60 enrolled VA Connecticut Healthcare System
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-03
Primary completion
2018-08
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum Toxin Type B Unknown Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic Intramuscular

Indications

No indication recorded.