Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

September 21, 2021 updated by: Anupama KizhakkeVeettil, Southern California University of Health Sciences

Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Acupuncture
Acupuncture needling, moxa, Tui Na and cupping.
Other: Chiropractic
Spinal manipulation and active and passive therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 60 days
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.
Change from baseline to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 60 days days
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.
Change from baseline to 60 days
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
Change from baseline to 60 days days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California University of Health Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIZH003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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