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

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ClinicalTrials.gov Identifier: NCT02008136
Recruitment Status : Unknown
Verified December 2017 by VA Connecticut Healthcare System.
Recruitment status was:  Recruiting
First Posted : December 11, 2013
Last Update Posted : December 7, 2017
Information provided by (Responsible Party):
VA Connecticut Healthcare System

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.

Condition or disease Intervention/treatment Phase
Cervicalgia Low Back Pain Drug: Botulinum Toxins Phase 1

Detailed Description:

Botulinum toxins are a well-established group of neurotoxins that have a wide variety of FDA approved clinical uses including muscle relaxation, headache prevention and bladder control. Despite the abundance of anecdotal evidence supporting their use in pain management, double blind placebo control studies examining the efficacy of botulinum toxins in the treatment of chronic neck and back pain have reported mixed findings. Several smaller studies have shown significantly positive outcomes while other studies have found no efficacy of neurotoxins compared to placebo. The existing literature reveals that most negative outcome studies were based on the Visual Analogue Scale, which is a purely subjective measure. We propose a more objective set of measures that might better reflect patients' deficits and levels of discomfort.

Our proposal is a prospective, open-label, pilot study that will examine chronic neck and back pain among veterans. Our primary specific aim is to test three novel methods for evaluating clinical deficits in patients who have chronic neck and back pain: electromyographical (EMG) activity (primary outcome) and cervical/lumbar range of motion (CROM & LROM) (primary outcome) as well as skin surface temperature (thermography) (secondary outcome). Our hypothesis is that most patients with chronic neck and back pain significantly from sustained muscle spasms. As a result, patients may exhibit surplus EMG activity in affected areas due to spontaneous muscle twitch. And consequently, they may show signs of decreased range of motion due to increased muscle tone. They may also experience a rise in skin surface temperature due to excess heat production from sustained muscle contraction. We will measure these three phenomena using three different biophysical measurement tools. Electromyographic data will be collected with a surface EMG device, and cervical and lumbar range of motion with a gravity inclinometer. Skin surface temperature will be assessed with a medical grade digital thermography camera.

The second specific aim of this study is to examine the efficacy of botulinum toxins in reversing the anomalies in the above measured parameters: to reduce excessive electromyographic activity, to increase range of motion in cervical and lumbar joints and to reduce elevated skin surface temperature. We will measure outcomes of 60 study subjects (30 for neck pain and 30 for low back pain) who will all be treated once with botulinum toxins and then followed up at 1 month, 2 months and 3 months. We will also correlate our findings with the more commonly used pain and function scales: the Visual Analogue Scale, Neck Disability Index and the Oswestry Low Back Pain Scale.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain
Study Start Date : March 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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)
Drug: Botulinum Toxins
intramuscular injections
Other Names:
  • Botox
  • Myobloc

Primary Outcome Measures :
  1. Lumbar Pain Rating Scale [ Time Frame: 3 months ]
    This is an 8 point rating scale for low back pain

Secondary Outcome Measures :
  1. digital thermography [ Time Frame: 3 months ]
    measurement of heat production from discrete muscle groups in the neck and low back using a medical grade infrared thermography camera

  2. VAS score [ Time Frame: 3 months ]
    Visual analogue scale

  3. Oswestry Lumbar Disability Scale [ Time Frame: 3 months ]
    A scoring system that assesses functional loss due to neck injury

  4. Cervical and Lumbar Range of Motion [ Time Frame: 3 months ]
    Measurement of spine rotation in x, y and z axes

  5. surface EMG (sEMG) [ Time Frame: 3 months ]
    non-invasive electrophysiological measurement of spontaneous muscle activity

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008136

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Contact: Hajime A Tokuno, MD 203-937-4724 hajime.tokuno@va.gov

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United States, Connecticut
VA Connecticut Healthcare Services Recruiting
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
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Principal Investigator: Hajime A Tokuno, MD VA Connecticut
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Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT02008136    
Other Study ID Numbers: 01769
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Connecticut Healthcare System:
myofascial pain
muscle spasm
botulinum toxin
low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neck Pain
Neurologic Manifestations
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs