The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00282958|
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Subacute Cervical Pain Subacute Upper Back Pain||Drug: Botulinum Toxin type a (Botox)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain|
|Study Start Date :||February 2003|
|Study Completion Date :||July 2006|
- NDI, VAS, SF-36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|