NCT01357343

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for phase_2 low-back-pain

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

March 22, 2011

Last Update Submit

September 21, 2021

Conditions

Low Back Pain

Keywords

Low back painChiropracticAcupunctureIntegrated care

Outcome Measures

Primary Outcomes (2)

  • Pain numeric rating scale.

    This outcome will measure changes in the participant's level of low back pain.

    Change from baseline to 60 days

  • 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 Outcomes (3)

  • Quality of life

    Change from baseline to 60 days days

  • Patient satisfaction with treatment

    Change from baseline to 60 days

  • Self generated survey of outcomes

    Change from baseline to 60 days days

Study Arms (3)

Acupuncture

ACTIVE COMPARATOR

Acupuncture needling, moxa, Tui Na and cupping

Other: Acupuncture

Chiropractic care

ACTIVE COMPARATOR

Chiropractic adjustments and active and passive physical modalities.

Other: Chiropractic

Integrated Chiropractic and Acupuncture

ACTIVE COMPARATOR
Other: ChiropracticOther: Acupuncture

Interventions

ChiropracticOTHER

Spinal manipulation and active and passive therapy.

Chiropractic careIntegrated Chiropractic and Acupuncture
AcupunctureOTHER

Acupuncture needling, moxa, Tui Na and cupping.

AcupunctureIntegrated Chiropractic and Acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are 18 years or older
  • Have a current episode of low back pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern California University of Health Sciences

Whittier, California, 90604, United States

Location

Related Publications (1)

  • Kizhakkeveettil A, Rose KA, Kadar GE, Hurwitz EL. Integrative Acupuncture and Spinal Manipulative Therapy Versus Either Alone for Low Back Pain: A Randomized Controlled Trial Feasibility Study. J Manipulative Physiol Ther. 2017 Mar-Apr;40(3):201-213. doi: 10.1016/j.jmpt.2017.01.002. Epub 2017 Mar 1.

    PMID: 28259496DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, ChiropracticAcupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeutics

Study Officials

  • Anupama Kizhakkeveettil, MAOM

    Southern California University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 22, 2011

First Posted

May 20, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

US(1)