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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01483573
Other study ID # 0120100079
Secondary ID
Status Terminated
Phase N/A
First received October 7, 2010
Last updated March 21, 2016
Start date May 2010
Est. completion date July 2015

Study information

Verified date March 2016
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study was designed to answer 3 primary research questions:

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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
neural mobilization
stretch the nerve
straight leg raise
stretch the hamstring

Locations

Country Name City State
United States New York University Langone Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Epub 2007 Mar 30. — View 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. Review. — View Citation

Schäfer 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. Review. — View Citation

Schäfer A, Hall T, Müller 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary range of motion Measured with a bubble inclinometer within 72 hours No
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