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Completed

NCT Number: NCT01357343

Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern California University of Health Sciences

Whittier, California, 90604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chiropractic

Other

Spinal manipulation and active and passive therapy.

Acupuncture

Other

Acupuncture needling, moxa, Tui Na and cupping.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Southern California University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 20, 2011
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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