Clinical trial NCT00282958: The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
Official title: The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Cervical Pain
Subacute Upper Back Pain
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2006-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.

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 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

Primary outcomes:
measure: NDI, VAS, SF-36
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VA Palo Alto Health Care System
name: Elaine Date, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Palo Alto Health Care System
name: Henry Lew, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: