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

This study is currently recruiting participants.
Verified November 2011 by University of Medicine and Dentistry New Jersey
Sponsor:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01483573
First received: October 7, 2010
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine if, among patients with low back pain and a positive SLR, those who are identified as having a positive SLR due to neurological symptoms demonstrate greater improvements in range of motion and low back pain symptoms if treated with nerve mobilization techniques than those who are treated with muscle stretching techniques.

2. To determine if, among patients with low back pain and a positive SLR, those who are identified as having a positive SLR due to hamstring shortness demonstrate greater improvements in range of motion and low back pain symptoms if treated with muscle stretching techniques than those who are treated with nerve mobilization techniques.


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

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

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

  • changes in function [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
    Measured with the Modified Oswestry Disability Index

  • Pain [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
    Numeric Pain Rating Scale (11 points, 0-10)


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (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, DPT dagatiml@umdnj.edu
Contact: Susan L Edmond, DSc 973-972-9732 edmondsl@umdnj.edu

Locations
United States, New Jersey
Barnabas Health Ambulatory Care Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Michael L D'Agati, DPT     973-322-7536     mdagati@sbhcs.com    
Contact: Anne McDonald, DPT     973 322 7529     agiblin@sbhcs.com    
Principal Investigator: Michael L D'Agati, DPT            
Sub-Investigator: Susan L Edmond, DSc            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
  More Information

Publications:
Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01483573     History of Changes
Other Study ID Numbers: 0120100079
Study First Received: October 7, 2010
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry 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 May 23, 2013