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Clinical Trials/NCT01357343
NCT01357343
Completed
Phase 2

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

Southern California University of Health Sciences1 site in 1 country103 target enrollmentFebruary 2011
ConditionsLow Back Pain

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Southern California University of Health Sciences
Enrollment
103
Locations
1
Primary Endpoint
Disability due to low back pain
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
December 2014
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anupama KizhakkeVeettil

Assistant Professor

Southern California University of Health Sciences

Eligibility 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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Patient satisfaction with treatment(Change from baseline to 60 days)
  • Quality of life(Change from baseline to 60 days days)
  • Self generated survey of outcomes(Change from baseline to 60 days days)

Study Sites (1)

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