NCT00282958

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Palo Alto Veterans Institute for Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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.

Conditions

• Subacute Cervical Pain
• Subacute Upper Back Pain

Interventions

Type	Name	Description
DRUG	Botulinum Toxin type a (Botox)

Timeline

• Start date: 2003-02-01
• Completion: 2006-07-01
• First posted: 2006-01-27
• Last updated: 2015-03-05