Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Anupama KizhakkeVeettil, Southern California University of Health Sciences

ClinicalTrials.gov Identifier:

NCT01357343

First received: March 22, 2011

Last updated: June 24, 2015

Last verified: June 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Low Back Pain	Other: Chiropractic Other: Acupuncture	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Back Pain Chiropractic

U.S. FDA Resources

Further study details as provided by Anupama KizhakkeVeettil, Southern California University of Health Sciences:

Primary Outcome Measures:

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.
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:

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.
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.
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


Enrollment:	103
Study Start Date:	February 2011
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357343

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


Responsible Party:	Anupama KizhakkeVeettil, Assistant Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:	NCT01357343 History of Changes
Other Study ID Numbers:	KIZH003
Study First Received:	March 22, 2011
Last Updated:	June 24, 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

ClinicalTrials.gov processed this record on July 27, 2017

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