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

Subacute Cervical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282958
• Other study ID #: DAT0014
• Status: Completed
• Phase: N/A
• First received: January 25, 2006
• Last updated: March 4, 2015
• Start date: February 2003
• Est. completion date: July 2006

Study information

• Verified date: March 2015
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Neck Pain
• Subacute Cervical Pain
• Subacute Upper Back Pain

Intervention

Drug:
• Botulinum Toxin type a (Botox)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NDI, VAS, SF-36