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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Palo Alto Institute for Research and Education, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:
NCT00282958
First received: January 25, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Palo Alto Institute for Research and Education, Inc:

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282958

Sponsors and Collaborators
Palo Alto Institute for Research and Education, Inc
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

No publications provided

ClinicalTrials.gov Identifier: NCT00282958     History of Changes
Other Study ID Numbers: DAT0014
Study First Received: January 25, 2006
Last Updated: January 25, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013