Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Southern California University of Health Sciences
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: July 17, 2014
Last verified: July 2014

March 22, 2011
July 17, 2014
February 2011
December 2014   (final data collection date for primary outcome measure)
  • Pain numeric rating scale. [ Time Frame: Change from baseline to 120 days ] [ Designated as safety issue: No ]
    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 120 days ] [ Designated as safety issue: No ]
    We will be using Roland-Morris scale to measure disability due to low back pain.
Same as current
Complete list of historical versions of study NCT01357343 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: Change from baseline to 120 days days ] [ Designated as safety issue: No ]
    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 120 days ] [ Designated as safety issue: No ]
    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 120 days days ] [ Designated as safety issue: No ]
    Frequency of symptoms, Medication use, Lost work time, Health services utilization
Same as current
Not Provided
Not Provided
 
Integrated Chiropractic and Acupuncture Treatment for Low Back Pain
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Back Pain
  • Other: Chiropractic
    Spinal manipulation and active and passive therapy.
  • Other: Acupuncture
    Acupuncture needling, moxa, Tui Na and cupping.
  • Active Comparator: Acupuncture
    Acupuncture needling, moxa, Tui Na and cupping
    Intervention: Other: Acupuncture
  • Active Comparator: Chiropractic care
    Chiropractic adjustments and active and passive physical modalities.
    Intervention: Other: Chiropractic
  • Active Comparator: Integrated Chiropractic and Acupuncture
    Interventions:
    • Other: Chiropractic
    • Other: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Anupama Kizhakkeveettil, MAOM 562-947-8755 ext 493 anupamakizhakkeveett@scuhs.edu
United States
 
NCT01357343
KIZH003
No
Anupama KizhakkeVeettil, Southern California University of Health Sciences
Southern California University of Health Sciences
Not Provided
Principal Investigator: Anupama Kizhakkeveettil, MAOM Southern California University of Health Sciences
Southern California University of Health Sciences
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP