Anxiety Clinical Trial
— CBNPOfficial title:
Efficacy of an Integrative Approach Utilizing Chiropractic as an Add On Therapy for the Treatment Back and Neck Pain in an Emergency Department Setting - A Comparative Randomized Controlled Trial
This study aims to examine the efficacy of an Integrative approach utilizing Chiropractic as
an add-on therapy for the treatment back and neck pain in an emergency department setting
Chiropractic is well established as an effective treatment for back pain. The investigators
cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an
effective therapy for simple back and neck pain in an emergency room (ER) setting.
This study will examine weather Chiropractic can decrease pain, increase range of motion and
decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain
without neurological findings. Chiropractic will be performed as an add on therapy on top of
analgesic therapy.
Status | Completed |
Enrollment | 52 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Adult male and females age 18-60 with acute or sub acute/chronic simple back or neck pain - Agreed to a physical examination and by an orthopedic physician and X-ray Diagnosis of simple back pain with levels of 4 < NRS at least - Agreed and able to fill pain, anxiety and satisfactory questioners - Agreed and able to sign informed consent Exclusion Criteria: - Fracture, sprain or neurological deficit during physical examination - Pain scale of NRS < 4 - Active pregnancy - Active inflammatory arthritis - History of CVA - Open wounds - Acute malignancy with life expectancy of less than 5 years - Experience with acupuncture treatments - History of drug addiction - History of osteoporosis - Declined or unable to sign informed consent - Soldiers in active military service - Received a chiropractic treatment in the past |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Asaf Harofeh Medical Center | Beer Yaakov, Zerifin |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A comparable difference in pain levels between a combined medication and chiropractic treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS) | 30 minutes after medication, Immidiatly after treatment and after 24 hrs | No | |
Secondary | A comparable difference in range of motion between a combined medication and chiropractic treatment to medication treatment alone as measured by Spine Scan Device and physical exam using goniometer | 30 minutes after medication, Immidiatly after treatment and after 24 hrs | No | |
Secondary | A comparable difference in patient self reported anxiety assessed by Hebrew version of the anxiety and somatization sections of the Symptom Check List-90 questioner (SCL-90) | Immidiatly after treatment | No | |
Secondary | A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours | 24 hours after treatment | No | |
Secondary | A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires | 1 hour after the treatment and again after 1 week | Yes |
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