Recruiting

Phase 1

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

Sponsor:

VA Connecticut Healthcare System

Code:

NCT02008136

Conditions

Cervicalgia

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Botulinum Toxins

Study Details

Brief 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.

Conditions

Cervicalgia

Low Back Pain

Study ID

NCT02008136

Start date

Mar, 2016

Status verified date

Dec, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: botulinum toxin injected

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)

Interventions

Botulinum Toxins

intramuscular injections

Primary outcome measure

Lumbar Pain Rating Scale [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Hajime A Tokuno, MD

203-937-4724 hajime.tokuno@va.gov

Locations

VA Connecticut Healthcare Services

Recruiting

West Haven, Connecticut, United States, 06516

More Information

Sponsor

VA Connecticut Healthcare System

Last update posted

Dec 7, 2017

Last verified

Dec, 2017

Keywords

myofascial pain
muscle spasm
botulinum toxin
cervicalgia
lumbago
low back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Connecticut Healthcare System on 2017-12-07.