The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
Information source: Palo Alto Institute for Research and Education, Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subacute Cervical Pain; Subacute Upper Back Pain
Intervention: Botulinum Toxin type a (Botox) (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Palo Alto Institute for Research and Education, Inc Official(s) and/or principal investigator(s):
Elaine Date, MD, Principal Investigator, Affiliation: VA Palo Alto Health Care System
Henry Lew, MD, Ph.D, Principal Investigator, Affiliation: VA Palo Alto Health Care System
Summary
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain
but also for subacute pain.
Clinical Details
Official title: The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: NDI, VAS, SF-36
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): 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
Locations and Contacts
Additional Information
Starting date: February 2003
Ending date: July 2006
Last updated: January 25, 2006
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