Subacute Cervical Pain Clinical Trial
Official title:
The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment