Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study is being conducted to compare the effectiveness of integrated chiropractic and acupuncture care for the management of low back pain.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: Chiropractic; Other: Acupuncture	Phase 2

Detailed Description:

This study is being conducted at the Southern California University of Health Sciences. Eligible subjects will be randomized to one of three treatment groups: chiropractic care alone, acupuncture care alone, and chiropractic and acupuncture care combined.

Subjects will be treated on pragmatic basis for 60 days and then followed up for an additional 60 days. All examinations and treatments will be provided free of charge. The expected benefits for the participants are decreased pain and improved function.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	103 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial
Study Start Date :	February 2011
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Acupuncture; Acupuncture needling, moxa, Tui Na and cupping	Other: Acupuncture; Acupuncture needling, moxa, Tui Na and cupping.
Active Comparator: Chiropractic care; Chiropractic adjustments and active and passive physical modalities.	Other: Chiropractic; Spinal manipulation and active and passive therapy.
Active Comparator: Integrated Chiropractic and Acupuncture	Other: Chiropractic; Spinal manipulation and active and passive therapy. Other: Acupuncture; Acupuncture needling, moxa, Tui Na and cupping.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pain numeric rating scale. [ Time Frame: Change from baseline to 60 days ]
   This outcome will measure changes in the participant's level of low back pain.
2. Disability due to low back pain [ Time Frame: Change from baseline to 60 days ]
   We will be using Roland-Morris scale to measure disability due to low back pain.

Secondary Outcome Measures :

1. Quality of life [ Time Frame: Change from baseline to 60 days days ]
   Quality of life is often reduced due to low back pain. The SF-36 outcome measure will be used to determine if the treatment has any effect on quality of life of the participants.
2. Patient satisfaction with treatment [ Time Frame: Change from baseline to 60 days ]
   We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.
3. Self generated survey of outcomes [ Time Frame: Change from baseline to 60 days days ]
   Frequency of symptoms, Medication use, Lost work time, Health services utilization

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Are 18 years or older
• Have a current episode of low back pain

Exclusion Criteria:

• Received chiropractic treatment or other manipulative therapies within the last month
• Received acupuncture treatment within the last month
• Visceral, systemic or joint inflammatory disease with referred pain to the back or pelvis
• Non-mechanical low back pain
• A history of low back surgery
• Osteoporosis
• Spondylolisthesis
• Coagulation disorder or are taking anticoagulant medication
• Prolonged systemic corticosteroid medication
• Progressive unilateral lower limb muscle weakness
• Symptoms or signs of cauda equina syndrome (e.g., bowel or bladder dysfunction)
• Severe concurrent illness (e.g., cancer, heart diseases, psychiatric disorders)
• Known pregnancy

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Southern California University of Health Sciences
Whittier, California, United States, 90604

Sponsors and Collaborators

Southern California University of Health Sciences

Investigators

Principal Investigator:	Anupama Kizhakkeveettil, MAOM	Southern California University of Health Sciences

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Anupama KizhakkeVeettil, Assistant Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:	NCT01357343 History of Changes
Other Study ID Numbers:	KIZH003
First Posted:	May 20, 2011
Last Update Posted:	June 25, 2015
Last Verified:	June 2015

Keywords provided by Anupama KizhakkeVeettil, Southern California University of Health Sciences:

Low back pain; Chiropractic; Acupuncture; Integrated care

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain	Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms