The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
|Subacute Cervical Pain Subacute Upper Back Pain||Drug: Botulinum Toxin type a (Botox)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain|
- NDI, VAS, SF-36
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||July 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282958
|Principal Investigator:||Elaine Date, MD||VA Palo Alto Health Care System|
|Principal Investigator:||Henry Lew, MD, Ph.D||VA Palo Alto Health Care System|