The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain - Full Text View

Sponsor:	Palo Alto Institute for Research and Education, Inc
Collaborator:	Allergan
Information provided by:	Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:	NCT00282958

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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Botox Neck Injuries and Disorders

Drug Information available for: Clostridium botulinum toxin

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

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

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Neck Pain
Nervous System Diseases
Physiological Effects of Drugs
Pain
Neuromuscular Agents
Back Pain
Pharmacologic Actions

Signs and Symptoms
Botulinum Toxins
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010