New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain
Unknown statusPhase 1NCT02008136
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain
- Conditions
- Cervicalgia
- Low Back Pain
- Interventions
- Drug: Botulinum Toxins
- Sponsor
- VA Connecticut Healthcare System
- Start date
- 2016-03
- Primary completion
- 2018-08
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02008136