NCT01900925

Brief Summary

There will be two groups of patients with low back pain (by randomization). Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

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

Timeline
Completed

Started Sep 2013

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

July 7, 2013

Last Update Submit

April 29, 2016

Conditions

Low Back Pain

Keywords

Low back pain, non-specific low back pain

Outcome Measures

Primary Outcomes (1)

  • Change in Modified Oswestry Disability Index

    The Modified Oswestry Disability Index (ODI) will be used to measure disability, will serve as the primary outcome measure for the study, and consists of 10 questions each scored from 0 to 5, with higher scores indicating greater disability. A 50% reduction in the ODI or greater from baseline has been considered a clinically important outcome.

    Baseline, 2 weeks, End of Intervention (Discharge)

Secondary Outcomes (4)

  • Change in Numeric Pain Rating Scale

    Baseline, 2 weeks, End of Intervention (Discharge)

  • Recovery

    End of Intervention (Discharge)

  • Change in Global Rating of Change Score

    2 weeks and End of Intervention (Discharge)

  • Change in Patient Satisfaction

    2 weeks and End of Intervention (Discharge)

Study Arms (2)

Low back treatment only (pragmatic)

ACTIVE COMPARATOR

1. advise to stay active, 2. discourage bed rest, 3. appropriate medication use, 4. reassurance. 5. Short term use of manipulation/medication, 6. supervised exercise, 7. cognitive behavioral therapy, 8. multidisciplinary treatment, 9. termination of use of modalities.

Procedure: Pragmatic low back pain treatment

LBP treatment and Hip treatment

EXPERIMENTAL

Group two will receive the same pragmatically applied, guideline-oriented treatment that is recommended from group 1. In addition, group 2 will receive prescriptive hip exercises that include 1) Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge, and the manual therapy treatment techniques of; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in prone.26 (See Appendix A for photos of the techniques and descriptions)

Procedure: Prescriptive Hip Exercises and Manual Therapy techniquesProcedure: Pragmatic low back pain treatment

Interventions

Prescriptive Hip Exercises and Manual Therapy techniquesPROCEDURE

1\) Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge,and; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in prone

LBP treatment and Hip treatment
Pragmatic low back pain treatmentPROCEDURE

1. advise to stay active, 2. discourage bed rest, 3. appropriate medication use, 4. reassurance. 5. Short term use of manipulation/medication, 6. supervised exercise, 7. cognitive behavioral therapy, 8. multidisciplinary treatment, 9. termination of use of modalities.

Also known as: Low back pain treatment
LBP treatment and Hip treatmentLow back treatment only (pragmatic)

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Mechanically producible LBP.
  • Minimum Modified Oswestry Disability Index score of 20%
  • Minimum baseline pain score of \>2.0/10 on the numeric analog scale for pain

You may not qualify if:

  • Presence of any red flags
  • Signs consistent with nerve root compression
  • Prior surgery to the lumbar spine
  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael J Bade, PhD, PT

    Regis University

    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
Professor

Study Record Dates

First Submitted

July 7, 2013

First Posted

July 17, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

US(1)