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Clinical Trials/NCT01357343
NCT01357343CompletedPhase 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 Sciences2 sites in 1 country103 target enrollmentStarted: February 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
103
Locations
2
Primary Endpoint
Disability due to low back pain

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anupama KizhakkeVeettil

Assistant Professor

Southern California University of Health Sciences

Study Sites (2)

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