NCT00916734

Brief Summary

The purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). The investigators do not know which of these two commonly-used treatments (manipulation or specific exercise) is better to treat low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_3 low-back-pain

Timeline
Completed

Started Nov 2007

Typical duration for phase_3 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

November 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 5, 2011

Status Verified

December 1, 2011

Enrollment Period

1.7 years

First QC Date

June 8, 2009

Last Update Submit

December 2, 2011

Conditions

Low Back Pain

Keywords

McKenziethrust manipulationclinical prediction rule

Outcome Measures

Primary Outcomes (1)

  • Pain level as measured on numerical pain rating scale

    1 year

Secondary Outcomes (1)

  • Oswestry score

    1 year

Study Arms (2)

Spinal Manipulation Group

EXPERIMENTAL

Subjects who received spinal thrust manipulation as an intervention.

Procedure: Spinal thrust manipulation

McKenzie MDT Group

ACTIVE COMPARATOR
Procedure: MDT (McKenzie Method)

Interventions

MDT (McKenzie Method)PROCEDURE

Subjects who perform exercises in their direction of preference.

Also known as: functional outcomes
McKenzie MDT Group
Spinal thrust manipulationPROCEDURE

Subjects who receive spinal thrust manipulation as an intervention.

Spinal Manipulation Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • people who meet the clinical prediction rule for spinal manipulation

You may not qualify if:

  • people receiving worker's compensation
  • those who have had spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daemen College

Amherst, New York, 14226, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald J Schenk, PT, PhD

    Daemen College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Physical Therapy

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 9, 2009

Study Start

November 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

December 5, 2011

Record last verified: 2011-12

Locations

US(1)