Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357343
• Other study ID #: KIZH003
• Status: Completed
• Phase: Phase 2
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: September 2021
• Source: Southern California University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Chiropractic
Spinal manipulation and active and passive therapy.
• Acupuncture
Acupuncture needling, moxa, Tui Na and cupping.

Locations

Country	Name	City	State
United States	Southern California University of Health Sciences	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain numeric rating scale.	This outcome will measure changes in the participant's level of low back pain.	Change from baseline to 60 days
Primary	Disability due to low back pain	We will be using Roland-Morris scale to measure disability due to low back pain.	Change from baseline to 60 days
Secondary	Quality of life	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.	Change from baseline to 60 days days
Secondary	Patient satisfaction with treatment	We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.	Change from baseline to 60 days
Secondary	Self generated survey of outcomes	Frequency of symptoms, Medication use, Lost work time, Health services utilization	Change from baseline to 60 days days