NCT01483573

Brief Summary

This study was designed to answer 3 primary research questions:

  1. 1.In adults with low back pain, reduced SLR ROM (Range of Motion) and a positive sensitized SLR (Straight leg raise) test, does neurodynamic mobilization result in greater SLR ROM, pain reduction and perceived improvement than muscle stretching?
  2. 2.In adults with low back pain, reduced SLR ROM and a negative sensitized SLR test, does muscle stretching result in greater SLR ROM, pain reduction and perceived improvement than neurodynamic mobilization?
  3. 3.In adults with low back and reduced SLR, does neurodynamic mobilization or muscle stretching result in greater SLR ROM, pain reduction and perceived improvement irrespective of the outcome of SLR sensitization?
  4. 4.Subjects determined to have nerve-related pain and ROM restrictions by a positive sensitized SLR test would benefit more from neurodynamic mobilization than muscle stretching.
  5. 5.Subjects determined to have muscle-related pain and ROM restrictions by a negative sensitized SLR test would benefit more from muscle stretching than neurodynamic mobilization.
  6. 6.Subjects would benefit the same from muscle stretching and neurodynamic mobilization when not matched on the outcome of the SLR sensitization.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

5.2 years

First QC Date

October 7, 2010

Last Update Submit

March 21, 2016

Conditions

Low Back Pain

Keywords

low back painstraight leg raise

Outcome Measures

Primary Outcomes (1)

  • range of motion

    Measured with a bubble inclinometer

    within 72 hours

Study Arms (2)

straight leg raise

EXPERIMENTAL

stretch the muscle

Other: straight leg raise

neural mobilization

EXPERIMENTAL

stretch the nerve

Other: neural mobilization

Interventions

neural mobilizationOTHER

stretch the nerve

neural mobilization
straight leg raiseOTHER

stretch the hamstring

Also known as: hamstring stretching
straight leg raise

Eligibility Criteria

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

You may qualify if:

  • Patients referred to physical therapy for low back pain with limitations in hamstring range of motion on the painful side

You may not qualify if:

  • Red flags

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (5)

  • Decoster LC, Cleland J, Altieri C, Russell P. The effects of hamstring stretching on range of motion: a systematic literature review. J Orthop Sports Phys Ther. 2005 Jun;35(6):377-87. doi: 10.2519/jospt.2005.35.6.377.

    PMID: 16001909BACKGROUND

  • Coppieters MW, Butler DS. Do 'sliders' slide and 'tensioners' tension? An analysis of neurodynamic techniques and considerations regarding their application. Man Ther. 2008 Jun;13(3):213-21. doi: 10.1016/j.math.2006.12.008. Epub 2007 Mar 30.

    PMID: 17398140BACKGROUND

  • Schafer A, Hall T, Briffa K. Classification of low back-related leg pain--a proposed patho-mechanism-based approach. Man Ther. 2009 Apr;14(2):222-30. doi: 10.1016/j.math.2007.10.003. Epub 2007 Dec 31.

    PMID: 18165145BACKGROUND

  • Schafer A, Hall T, Muller G, Briffa K. Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study. Eur Spine J. 2011 Mar;20(3):482-90. doi: 10.1007/s00586-010-1632-2. Epub 2010 Dec 1.

    PMID: 21116662BACKGROUND

  • Boyd BS, Wanek L, Gray AT, Topp KS. Mechanosensitivity of the lower extremity nervous system during straight-leg raise neurodynamic testing in healthy individuals. J Orthop Sports Phys Ther. 2009 Nov;39(11):780-90. doi: 10.2519/jospt.2009.3002.

    PMID: 19881004BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susan L Edmond, PT, DSc, OCS

    University of Medicine and Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2010

First Posted

December 1, 2011

Study Start

May 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

US(1)