NCT01211613

Brief Summary

The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable 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

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
Last Updated

January 30, 2017

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

September 28, 2010

Results QC Date

November 5, 2014

Last Update Submit

December 1, 2016

Conditions

Low Back Pain

Keywords

ManipulationChiropracticLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • Oswestry Low Back Pain Disability Index

    The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).

    4 weeks (post treatment)

Secondary Outcomes (1)

  • Numeric Pain Rating Score.

    4 weeks (post treatment)

Study Arms (3)

Manual Manipulation

EXPERIMENTAL

Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.

Procedure: Manual Manipulation

Mechanical Manipulation

EXPERIMENTAL

Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.

Device: Mechanically-assisted manipulation

Standard Medical Care

ACTIVE COMPARATOR

Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

Other: Standard Medical Care

Interventions

Manual ManipulationPROCEDURE

Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.

Manual Manipulation
Mechanically-assisted manipulationDEVICE

Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.

Also known as: Activator IV Instrument: FDA approval# K003185
Mechanical Manipulation
Standard Medical CareOTHER

Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

Standard Medical Care

Eligibility Criteria

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

You may qualify if:

  • Age: ≥ 18 years of age
  • Ability to read and write English
  • Experiencing a new episode of low back pain (LBP) with onset in the past 3 months
  • Oswestry Disability Index score between 20-70 points (0-100 scale)
  • Numeric pain rating score between 3-8 points (0-10 scale)

You may not qualify if:

  • Prior history of lumbar spine surgery
  • History of unstable spondylolisthesis, spinal stenosis, or scoliosis \> 20°
  • Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity
  • History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of \>10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication
  • Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months)
  • Receiving any on-going medical care for this episode of low back pain
  • Current use of opiate or other prescription medications for low back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center: Center for Integrative Medicine

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (2)

  • Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A. Mechanical vs manual manipulation for low back pain: an observational cohort study. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200. doi: 10.1016/j.jmpt.2010.01.010.

    PMID: 20350672BACKGROUND

  • Tonelli Enrico V, Schneider M, Haas M, Vo N, Huang W, McFarland C, Weber N, Sowa G. The association of biomarkers with pain and function in acute and subacute low back pain: a secondary analysis of an RCT. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1059. doi: 10.1186/s12891-022-06027-9.

    PMID: 36471334DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Results Point of Contact

Title
Michael J Schneider, DC, PhD
Organization
University of Pittsburgh, Department of Physical Therapy'
mjs5@pitt.edu
412-383-6640

Study Officials

  • Michael J Schneider, PhD, DC

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DC, PhD

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2013

Study Completion

October 1, 2013

Last Updated

January 30, 2017

Results First Posted

November 24, 2014

Record last verified: 2016-12

Locations

US(1)