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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Connecticut Healthcare System
• Treatments: Botulinum Toxins; rimabotulinumtoxinB

Criteria

Inclusion Criteria:

• Veterans with chronic neck or back pain for at least 6 months.

• No botulinum toxin injections in the last 6 months.

Exclusion Criteria:

• 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)