Chiropractic for Back and Neck Pain in an Emergency Department Setting

Phase 1

Completed

• Conditions: Back Pain; Neck Pain; Anxiety
• Interventions: Procedure: real chiropractic; Procedure: Sham Chiropractic

• Registration Number: NCT00964717
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chiropractic	real chiropractic	Real Chiropractic treatment
Sham Chiropractic	Sham Chiropractic	stimulation utilizing 'activator' thumper

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Asaf Harofeh Medical Center; 🇮🇱 Beer Yaakov, Zerifin, Israel