Chiropractic for Back and Neck Pain in an Emergency Department Setting

Anxiety Clinical Trial

— CBNP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964717
• Other study ID #: 126/08
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 11, 2009
• Last updated: January 27, 2012
• Start date: May 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Back Pain
• Neck Pain

Intervention

Procedure:
• real chiropractic
real chiropractic manipulation
• Sham Chiropractic
Placebo stimulation using 'activator' thumper

Locations

Country	Name	City	State
Israel	Asaf Harofeh Medical Center	Beer Yaakov, Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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