- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483573
Effect of Hamstring Stretching and Neural Mobilization on Range of Motion and Low Back Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University Langone Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: straight leg raise
stretch the muscle
|
stretch the hamstring
Other Names:
|
EXPERIMENTAL: neural mobilization
stretch the nerve
|
stretch the nerve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
range of motion
Time Frame: within 72 hours
|
Measured with a bubble inclinometer
|
within 72 hours
|
Collaborators and Investigators
Investigators
- Study Director: Susan L Edmond, PT, DSc, OCS, University of Medicine and Dentistry
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0120100079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on straight leg raise
-
Alessandro HaupenthalSanta Catarina Federal UniversityUnknown
-
Andrews Research & Education FoundationFloridaRecruiting
-
University of MilanMedical University of Vienna; Ohio State University; University of Campania "Luigi... and other collaboratorsRecruitingGastroesophageal RefluxItaly
-
Riphah International UniversityCompletedLumbar RadiculopathyPakistan
-
Riphah International UniversityCompletedPelvic Girdle PainPakistan
-
Sahreen AnwarRecruiting
-
Riphah International UniversityCompletedWeakness, Muscle | SIJ - Sprain of Sacroiliac Joint | Tightness of Back MusclesPakistan
-
Universitat Internacional de CatalunyaCompletedMuscle StretchingSpain
-
University of Wisconsin, MadisonCarroll UniversityRecruitingMuscle Weakness | Muscle Fatigue | Postpartum | Force Steadiness | NulligravidUnited States
-
Riphah International UniversityCompleted