Trial record 4 of 29 for:    Open Studies | chiropractic

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
  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
Endpoint Classification: Efficacy Study
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:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Anupama Kizhakkeveettil, MAOM 562-947-8755 ext 493 anupamakizhakkeveett@scuhs.edu

Locations
United States, California
Southern California University of Health Sciences Recruiting
Whittier, California, United States, 90604
Principal Investigator: Anupama Kizhakkeveettil, MAOM         
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
Principal Investigator: Anupama Kizhakkeveettil, MAOM Southern California University of Health Sciences
  More Information

No publications provided

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: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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 September 18, 2014