NCT00885001

Brief Summary

The general purpose of this pilot study is to determine the effects of a novel exercise intervention (short arc banding (SAB)) on the cross sectional area of lumbar multifidus well as functional outcomes assessments in patients with chronic low back pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 21, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

April 17, 2009

Last Update Submit

April 20, 2009

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Diagnostic ultrasound

    beginning of the trial, at the two week mark and the end of the trial

Secondary Outcomes (2)

  • Revised Oswestery Low Back Disability Questionnaire

    at the beginning and end of the trail

  • Quadruple Visual Analogue Scale

    Beginning and end of the trial

Study Arms (1)

Short Arc Banding Group

EXPERIMENTAL

Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention.

Procedure: Short Arc Banding

Interventions

Short Arc BandingPROCEDURE

Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention.

Short Arc Banding Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic mechanical low back pain (LBP) with a duration of greater than six weeks, severity and location remaining the same
  • No current radicular symptoms extending below the knee
  • Logan College Faculty, staff, as well as patients from any of Logan Health Center's allied clinics

You may not qualify if:

  • Current radicular symptoms extending below the knee
  • A history of neurological disease,
  • History of severe lumbar trauma or surgery
  • Contraindications to lumbar manipulation
  • Current use of muscle relaxants or analgesics
  • Degenerative joint disease (DJD)
  • Recent spinal manipulative therapy (within 2 weeks of start of trial)
  • Current use of modalities (e-stim, vibration, etc) and other exercise
  • Diabetes
  • Heart, kidney thyroid disorders and chronic disease
  • Female subjects who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Logan College of Chiropractic

Chesterfield, Missouri, 63017, United States

RECRUITING

Central Study Contacts

Adam Morrell, DC

CONTACT

(636) 227-2100Adam.Morrell@logan.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 21, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 21, 2009

Record last verified: 2009-04

Locations

US(1)