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

Status unconfirmed · Phase 1

Conditions studied: Cervicalgia, Low Back Pain

In brief

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.

Key facts

Study ID

NCT02008136

Run by

VA Connecticut Healthcare System

People needed

60

Starts

2016-03-01

Expected to finish

2018-12-01

Last updated by the study team

2017-12-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• VA Connecticut Healthcare Services — West Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.