Effect of Hamstring Stretching and Neural Mobilization on Range of Motion and Low Back Pain
Primary Purpose
Low Back Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neural mobilization
straight leg raise
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, straight leg raise
Eligibility 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
Sites / Locations
- New York University Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
straight leg raise
neural mobilization
Arm Description
stretch the muscle
stretch the nerve
Outcomes
Primary Outcome Measures
range of motion
Measured with a bubble inclinometer
Secondary Outcome Measures
Full Information
NCT ID
NCT01483573
First Posted
October 7, 2010
Last Updated
March 21, 2016
Sponsor
University of Medicine and Dentistry of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01483573
Brief Title
Effect of Hamstring Stretching and Neural Mobilization on Range of Motion and Low Back Pain
Official Title
Effect of Hamstring Stretching and Neural Mobilization on Range of Motion and Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment over time
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was designed to answer 3 primary research questions:
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?
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?
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:
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.
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.
Subjects would benefit the same from muscle stretching and neurodynamic mobilization when not matched on the outcome of the SLR sensitization.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, straight leg raise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
straight leg raise
Arm Type
Experimental
Arm Description
stretch the muscle
Arm Title
neural mobilization
Arm Type
Experimental
Arm Description
stretch the nerve
Intervention Type
Other
Intervention Name(s)
neural mobilization
Intervention Description
stretch the nerve
Intervention Type
Other
Intervention Name(s)
straight leg raise
Other Intervention Name(s)
hamstring stretching
Intervention Description
stretch the hamstring
Primary Outcome Measure Information:
Title
range of motion
Description
Measured with a bubble inclinometer
Time Frame
within 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Edmond, PT, DSc, OCS
Organizational Affiliation
University of Medicine and Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16001909
Citation
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.
Results Reference
background
PubMed Identifier
17398140
Citation
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.
Results Reference
background
PubMed Identifier
18165145
Citation
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.
Results Reference
background
PubMed Identifier
21116662
Citation
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.
Results Reference
background
PubMed Identifier
19881004
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Hamstring Stretching and Neural Mobilization on Range of Motion and Low Back Pain
We'll reach out to this number within 24 hrs