Effect of Hamstring Stretching and Neural Mobilization on Range of Motion and Low Back Pain

This study is currently recruiting participants.
Verified May 2013 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT01483573
First received: October 7, 2010
Last updated: February 11, 2014
Last verified: May 2013
  Purpose

This study was designed to answer 3 primary research questions:

  1. In adults with low back pain, reduced SLR ROM and a positive sensitized SLR test, does neurodynamic mobilization result in greater SLR ROM, pain reduction and perceived improvement than muscle stretching?
  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. 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?

The research hypotheses are threefold:

  1. 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.
  2. 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.
  3. Subjects would benefit the same from muscle stretching and neurodynamic mobilization when not matched on the outcome of the SLR sensitization.

Condition Intervention
Low Back Pain
Other: neural mobilization
Other: straight leg raise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effect of Hamstring Stretching and Neural Mobilization on Range of Motion and Low Back Pain

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • range of motion [ Time Frame: within 72 hours ] [ Designated as safety issue: No ]
    Measured with a bubble inclinometer


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: straight leg raise
stretch the muscle
Other: straight leg raise
stretch the hamstring
Other Name: hamstring stretching
Experimental: neural mobilization
stretch the nerve
Other: neural mobilization
stretch the nerve

Detailed Description:

Potential subjects will sign an informed consent and be evaluated for inclusion in the study. Subjects meeting the inclusion criteria will be asked to complete a form asking questions regarding their demographics, pain history and symptomatology. The form will also include a numeric pain rating scale to determine pain severity, and a standardized questionnaire commonly used in back pain research (i.e., the Modified Oswestry Disability Index). Subjects will then be evaluated for SLR range of motion on the side with the least amount of SLR range of motion using a bubble inclinometer.

Subjects will then be randomly assigned to receive a treatment to address hamstring length or a treatment to address sciatic nerve restrictions. A second researcher who is blinded to the results of the data obtained pre-treatment will administer the treatment. Hamstring stretching will consist of positioning the subject's hip in flexion and knee in extension, and holding this position for 30 seconds. This treatment will be repeated 5 times. Nerve mobilization will consist of either momentarily positioning the hip in flexion, the knee in extension and the ankle in dorsiflexion, and then moving the ankle in and out of dorsiflexion at a rate of about 1 - 2 movements per second (theoretically, this should stretch the nerve), or moving the lower leg such that it is first positioned into hip extension and ankle dorsiflexion, and then into hip flexion and ankle plantarflexion (theoretically, this should glide the nerve in its sheath). The choice of technique will be made by the treating therapist. Both treatments should take approximately 4 minutes to complete.

Following this intervention, subjects will be re-evaluated for SLR range of motion using a bubble inclinometer by the same researcher who collected the pre-treatment data. During the next visit to physical therapy, this researcher will re-evaluate subjects SLR range of motion, as previously described; and pain, by the numeric pain rating scale.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Red flags
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483573

Contacts
Contact: Michael L D'Agati, PT, DPT 646-501-7077 dagatiml@shrp.rutgers.edu
Contact: Susan L Edmond, PT, DSc 973-972-9732 edmondsl@shrp.rutgers.edu

Locations
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Michael L D'Agati, PT, DPT    646-501-7077    Michael.D'Agati@nyumc.org   
Contact: James Koo, PT, DPT    646-501-7077    James.Koo@nyumc.org   
Principal Investigator: Michael L D'Agati, PT, DPT         
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Study Director: Susan L Edmond, PT, DSc, OCS University of Medicine and Dentistry
  More Information

Publications:
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT01483573     History of Changes
Other Study ID Numbers: 0120100079
Study First Received: October 7, 2010
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
low back pain
straight leg raise

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014