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The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282958
First Posted: January 27, 2006
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
Palo Alto Veterans Institute for Research
  Purpose
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.

Condition Intervention
Subacute Cervical Pain Subacute Upper Back Pain Drug: Botulinum Toxin type a (Botox)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain

Resource links provided by NLM:


Further study details as provided by Palo Alto Veterans Institute for Research:

Primary Outcome Measures:
  • NDI, VAS, SF-36

Study Start Date: February 2003
Estimated Study Completion Date: July 2006
Detailed Description:

Subjects diagnosed with subacute (2-6 months post-onset) bilateral cervical/ upper back pain will be recruited in this double-blind control study.

A total of 30 subjects with subacute cervical/upper back pain will be recruited. If patients are qualified as participants and agreed to participate in the study by signing the consent form, they will be randomized into either (A) control group (injection of normal saline injection) or (B) study group (injection of BOTOX). The initial history taking step will include medical history including medication and surgery history, duration of pain, pre-injection neck disability index (NDI) and visual analogue scale (VAS) for pain. VAS score will be collected for 4 weeks before injection to ensure stable VAS, otherwise medical records will be reviewed to ensure stable feature of pain. Short Form (SF) -36 Health Survey will be used to assess functional status, and the Beck Depression Inventory (BDI) will be applied to assess psychological aspect. Physical examination will be performed to determine the most tender cervical/ upper back muscles, and rule out operative condition. A simple swallowing test (3-oz water swallowing test) will be applied for dysphagia screening.

The patients will be maintained with routine, standardized physical therapy, oral medication, and stretch exercise after the injection. NDI, VAS, and SF-36 questionnaire will be re-collected at 1, 2, 3, 4, and 6 months after the injection session.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Male or female 18 y/o or greater,
  • Subacute bilateral cervical/ upper back pain, pain of longer than 2 months and shorter than 6 months duration,
  • VAS pain score of 5 or greater for the cervical/ upper back pain for 4 week period before injection,
  • If female or child bearing potential, concurrent use of a reliable method of contraception.

Exclusion Criteria:

  • Known allergy or sensitivity to Botulinum toxin type A.
  • Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
  • Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function
  • Pregnancy, breast feeding, or planned pregnancy
  • Acute or operative pathology on cervical MRI
  • History of treatment for gatro-esophageal reflux disease
  • Abnormal finding on 3-oz water swallowing test on the initial screening visit
  Contacts and Locations
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): NCT00282958


Sponsors and Collaborators
Palo Alto Veterans Institute for Research
Allergan
Investigators
Principal Investigator: Elaine Date, MD VA Palo Alto Health Care System
Principal Investigator: Henry Lew, MD, Ph.D VA Palo Alto Health Care System
  More Information

ClinicalTrials.gov Identifier: NCT00282958     History of Changes
Other Study ID Numbers: DAT0014
First Submitted: January 25, 2006
First Posted: January 27, 2006
Last Update Posted: March 5, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Back Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents