Lumbar Spinal StenosisNCT03368638
Physical Therapy Treatments, Including Neural Mobilization and Hip/Back Stretches for People Between 50-89 With Lumbar Spinal Stenosis and Leg Pain Provoked by Walking
A study testing Physical therapy intervention in people with Lumbar Spinal Stenosis, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Aging of the back is common in the older people and can result in difficulties standing and walking. Conservative treatment is recommended before considering surgery. Some recommended exercises involve the use of expensive equipment. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Physical therapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 22 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 50-89 years old
- Intermittent unilateral or bilateral leg pain occurring with walking and standing activities that is relieved only with sitting or by assuming flexed positions
- Magnetic Resonance Imaging (MRI) confirmation of lumbar spinal stenosis
- Leg symptoms greater than 4/10 and provoked within 15 minutes of walking
Who cannot join
- Prior lumbar surgery
- Spinal injection in last 6 weeks
- Impaired walking tolerance due to factors other than neurogenic claudication
- Inability to follow the rater's instructions
- Any medical contra-indication for hip mobilizations in extension or flexion
- Current medico-legal issues
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Amarillo, Texas, 79109
About this study
Official title: Neural And Hip Mobilizations In Patients With Neurogenic Claudication Associated With Degenerative Lumbar Spinal Stenosis: A Case Series
Aging of the back is common in the older people and can result in difficulties standing and walking. Conservative treatment is recommended before considering surgery. Some recommended exercises involve the use of expensive equipment. The present study plans to evaluate if specifically moving the nerves in the legs/back and improving flexibility of the hip and back can benefit patients. These exercises require no equipment, are simple to perform, and can provide patients a way to continue to perform these exercises at home. The purposes of this study are to (1) observe the benefit of a treatment program involving moving the nerves of the leg/back, stretching the legs and low back in patients with low back pain and difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Physical therapy intervention
- Keywords
- Degenerative lumbar spinal stenosis, Neural mobilization, Hip extension mobilization, Case series, Neurogenic claudication
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy interventionOther
Double knee to chest stretches, hip extension mobilization, neural mobilizations, home exercises program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Physical therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Swiss Spinal Stenosis Questionnaire
The Swiss Spinal Stenosis Questionnaire is a condition specific measure used for subjects with lumbar spinal stenosis. The measure consists of three separate subscales: Symptom, Functional, Satisfaction. Each scale has five to seven items, with each item scored on a Likert response scale with four to five options. The subscale score is calculated as the unweighted mean of all answered items, with a range of scores for each subscale as follows: one to five for symptom severity, one to four for physical function, and one to four for satisfaction. Lower scores represent fewer symptoms, greater function, and greater satisfaction with the results of their treatment. The subscale scores will be assessed independently of each other.
Measured: Baseline, 3-6 weeks, 3-6 months
Change in Numeric Pain Rating Scale
The Numeric Pain Rating Scale is an objective measure for subjects to rate their pain. This measure uses an 11 point scale where "0" represents "no pain" and "10" represents "the worst imaginable pain". Subjects in this study will be asked to rate their average pain during walking activities during the past week. The NPRS is a valid measure that has been shown to have good test-retest reliability (ICC = 0.61) (Childs et al 2005). This measure has been used in previous studies examining subjects with degenerative LSS.
Measured: Baseline, 3-6 weeks, 3-6 months
Change in Total Ambulation Time
Total Ambulation Time is an objective test to measure walking tolerance that has shown concordance correlation coefficient of 0.96 test-retest reliability in subjects with lumbar spinal stenosis (Deen et al 2000). This is a valid measure as it reproduces a subject's symptoms in the same manner as they are reproduced during daily life. Subjects will be asked to ambulate on a treadmill in a fully erect posture at a self-selected walking pace. Subjects will not be permitted to lean forward or hold onto handrails. Ambulation will be stopped at 15 minutes or when the subject reports a level of discomfort in their leg(s) that would cause them to stop walking in usual daily life situations (Deen et al 2000). The subject will be asked to remain standing for up to 15 seconds (if tolerated) in order to assess whether the leg symptoms can resolve in standing or if sitting is required. Longer walking times are considered an improvement in condition with this test.
Measured: Baseline, 3-6 weeks
Change in Time to First Symptoms
Time to First Symptoms is an objective test used to record the time it takes before the onset of leg symptoms during treadmill ambulation. This measure has shown concordance correlation coefficient of 0.98 for test-retest reliability in subjects with lumbar spinal stenosis (Deen et al 2000). It is a valid measure of leg symptoms onset during an ambulation activity, which is responsible for symptom onset in daily life. Subjects will ambulate on a treadmill in a fully erect posture. Subjects will ambulate at a self-selected comfortable walking pace and will not be permitted to lean forward or hold onto handrails. Subjects will be asked to report the moment of first onset of leg symptoms (unilateral or bilateral leg pain, fatigue, paresthesia, and/or tightness). Longer times to the onset of first symptoms are considered an improvement in condition with this test
Measured: Baseline, 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Jan 2018
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case Series
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reid D Gehring, DPT, Principal investigator, Texas Tech University Health Sciences CenterJean-Michel Brismee, ScD, Study chair, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368638
- Sponsor's protocol ID
- A17-4019
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2017
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All collected IPD
Publications
Ammendolia C, Chow N. Clinical outcomes for neurogenic claudication using a multimodal program for lumbar spinal stenosis: a retrospective study. J Manipulative Physiol Ther. 2015 Mar-Apr;38(3):188-94. doi: 10.1016/j.jmpt.2014.12.006. Epub 2015 Jan 22.
PubMed 25620608Backstrom KM, Whitman JM, Flynn TW. Lumbar spinal stenosis-diagnosis and management of the aging spine. Man Ther. 2011 Aug;16(4):308-17. doi: 10.1016/j.math.2011.01.010. Epub 2011 Mar 2.
PubMed 21367646Bade M, Cobo-Estevez M, Neeley D, Pandya J, Gunderson T, Cook C. Effects of manual therapy and exercise targeting the hips in patients with low-back pain-A randomized controlled trial. J Eval Clin Pract. 2017 Aug;23(4):734-740. doi: 10.1111/jep.12705. Epub 2017 Jan 27.
PubMed 28127827Bodack MP, Monteiro M. Therapeutic exercise in the treatment of patients with lumbar spinal stenosis. Clin Orthop Relat Res. 2001 Mar;(384):144-52. doi: 10.1097/00003086-200103000-00017.
PubMed 11249159Burns SA, Mintken PE, Austin GP, Cleland J. Short-term response of hip mobilizations and exercise in individuals with chronic low back pain: a case series. J Man Manip Ther. 2011 May;19(2):100-7. doi: 10.1179/2042618610Y.0000000007.
PubMed 22547920Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
PubMed 15928561Cleland JA, Whitman JM, Houser JL, Wainner RS, Childs JD. Psychometric properties of selected tests in patients with lumbar spinal stenosis. Spine J. 2012 Oct;12(10):921-31. doi: 10.1016/j.spinee.2012.05.004. Epub 2012 Jun 28.
PubMed 22749295Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test-retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc. 2000 Oct;75(10):1002-7. doi: 10.4065/75.10.1002.
PubMed 11040847Ellis RF, Hing WA. Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther. 2008;16(1):8-22. doi: 10.1179/106698108790818594.
PubMed 19119380Fritz JM, Delitto A, Welch WC, Erhard RE. Lumbar spinal stenosis: a review of current concepts in evaluation, management, and outcome measurements. Arch Phys Med Rehabil. 1998 Jun;79(6):700-8. doi: 10.1016/s0003-9993(98)90048-x.
PubMed 9630153Genevay S, Atlas SJ. Lumbar spinal stenosis. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):253-65. doi: 10.1016/j.berh.2009.11.001.
PubMed 20227646Gilbert KK, Roger James C, Apte G, Brown C, Sizer PS, Brismee JM, Smith MP. Effects of simulated neural mobilization on fluid movement in cadaveric peripheral nerve sections: implications for the treatment of neuropathic pain and dysfunction. J Man Manip Ther. 2015 Sep;23(4):219-25. doi: 10.1179/2042618614Y.0000000094.
PubMed 26917940Gilbert KK, Smith MP, Sobczak S, James CR, Sizer PS, Brismee JM. Effects of lower limb neurodynamic mobilization on intraneural fluid dispersion of the fourth lumbar nerve root: an unembalmed cadaveric investigation. J Man Manip Ther. 2015 Dec;23(5):239-45. doi: 10.1179/2042618615Y.0000000009.
PubMed 26955255Goren A, Yildiz N, Topuz O, Findikoglu G, Ardic F. Efficacy of exercise and ultrasound in patients with lumbar spinal stenosis: a prospective randomized controlled trial. Clin Rehabil. 2010 Jul;24(7):623-31. doi: 10.1177/0269215510367539. Epub 2010 Jun 8.
PubMed 20530650Inufusa A, An HS, Lim TH, Hasegawa T, Haughton VM, Nowicki BH. Anatomic changes of the spinal canal and intervertebral foramen associated with flexion-extension movement. Spine (Phila Pa 1976). 1996 Nov 1;21(21):2412-20. doi: 10.1097/00007632-199611010-00002.
PubMed 8923625
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural And Hip Mobilizations In Patients With Neurogenic Claudication Associated With Degenerative Lumbar Spinal Stenosis: A Case Series
- ClinicalTrials.gov ID
- NCT03368638
- Acronym / sponsor ID
- A17-4019
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Degenerative lumbar spinal stenosis, Neural mobilization, Hip extension mobilization, Case series, Neurogenic claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aging of the back is common in the older people and can result in difficulties standing and walking. Conservative treatment is recommended before considering surgery. Some recommended exercises involve the use of expensive equipment. The present study plans to evaluate if specifically moving the nerves in the legs/back and improving flexibility of the hip and back can benefit patients. These exercises require no equipment, are simple to perform, and can provide patients a way to continue to perform these exercises at home. The purposes of this study are to (1) observe the benefit of a treatment program involving moving the nerves of the leg/back, stretching the legs and low back in patients with low back pain and difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Series
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physical therapy intervention |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged between 50-89 years old
- Intermittent unilateral or bilateral leg pain occurring with walking and standing activities that is relieved only with sitting or by assuming flexed positions
- Magnetic Resonance Imaging (MRI) confirmation of lumbar spinal stenosis
- Leg symptoms greater than 4/10 and provoked within 15 minutes of walking
Key exclusion criteria (6 listed)
- Prior lumbar surgery
- Spinal injection in last 6 weeks
- Impaired walking tolerance due to factors other than neurogenic claudication
- Inability to follow the rater's instructions
- Any medical contra-indication for hip mobilizations in extension or flexion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy interventionDouble knee to chest stretches, hip extension mobilization, neural mobilizations, home exercises program | Other | Intervention |
Primary outcome
Change in Swiss Spinal Stenosis Questionnaire
Time frame: Baseline, 3-6 weeks, 3-6 months
The Swiss Spinal Stenosis Questionnaire is a condition specific measure used for subjects with lumbar spinal stenosis. The measure consists of three separate subscales: Symptom, Functional, Satisfaction. Each scale has five to seven items, with each item scored on a Likert response scale with four to five options. The subscale score is calculated as the unweighted mean of all answered items, with a range of scores for each subscale as follows: one to five for symptom severity, one to four for physical function, and one to four for satisfaction. Lower scores represent fewer symptoms, greater function, and greater satisfaction with the results of their treatment. The subscale scores will be assessed independently of each other.
Change in Numeric Pain Rating Scale
Time frame: Baseline, 3-6 weeks, 3-6 months
The Numeric Pain Rating Scale is an objective measure for subjects to rate their pain. This measure uses an 11 point scale where "0" represents "no pain" and "10" represents "the worst imaginable pain". Subjects in this study will be asked to rate their average pain during walking activities during the past week. The NPRS is a valid measure that has been shown to have good test-retest reliability (ICC = 0.61) (Childs et al 2005). This measure has been used in previous studies examining subjects with degenerative LSS.
Change in Total Ambulation Time
Time frame: Baseline, 3-6 weeks
Total Ambulation Time is an objective test to measure walking tolerance that has shown concordance correlation coefficient of 0.96 test-retest reliability in subjects with lumbar spinal stenosis (Deen et al 2000). This is a valid measure as it reproduces a subject's symptoms in the same manner as they are reproduced during daily life. Subjects will be asked to ambulate on a treadmill in a fully erect posture at a self-selected walking pace. Subjects will not be permitted to lean forward or hold onto handrails. Ambulation will be stopped at 15 minutes or when the subject reports a level of discomfort in their leg(s) that would cause them to stop walking in usual daily life situations (Deen et al 2000). The subject will be asked to remain standing for up to 15 seconds (if tolerated) in order to assess whether the leg symptoms can resolve in standing or if sitting is required. Longer walking times are considered an improvement in condition with this test.
Change in Time to First Symptoms
Time frame: Baseline, 3-6 weeks
Time to First Symptoms is an objective test used to record the time it takes before the onset of leg symptoms during treadmill ambulation. This measure has shown concordance correlation coefficient of 0.98 for test-retest reliability in subjects with lumbar spinal stenosis (Deen et al 2000). It is a valid measure of leg symptoms onset during an ambulation activity, which is responsible for symptom onset in daily life. Subjects will ambulate on a treadmill in a fully erect posture. Subjects will ambulate at a self-selected comfortable walking pace and will not be permitted to lean forward or hold onto handrails. Subjects will be asked to report the moment of first onset of leg symptoms (unilateral or bilateral leg pain, fatigue, paresthesia, and/or tightness). Longer times to the onset of first symptoms are considered an improvement in condition with this test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 25620608Ammendolia C, Chow N. Clinical outcomes for neurogenic claudication using a multimodal program for lumbar spinal stenosis: a retrospective study. J Manipulative Physiol Ther. 2015 Mar-Apr;38(3):188-94. doi: 10.1016/j.jmpt.2014.12.006. Epub 2015 Jan 22.
- Background: PubMed 21367646Backstrom KM, Whitman JM, Flynn TW. Lumbar spinal stenosis-diagnosis and management of the aging spine. Man Ther. 2011 Aug;16(4):308-17. doi: 10.1016/j.math.2011.01.010. Epub 2011 Mar 2.
- Background: PubMed 28127827Bade M, Cobo-Estevez M, Neeley D, Pandya J, Gunderson T, Cook C. Effects of manual therapy and exercise targeting the hips in patients with low-back pain-A randomized controlled trial. J Eval Clin Pract. 2017 Aug;23(4):734-740. doi: 10.1111/jep.12705. Epub 2017 Jan 27.
- Background: PubMed 11249159Bodack MP, Monteiro M. Therapeutic exercise in the treatment of patients with lumbar spinal stenosis. Clin Orthop Relat Res. 2001 Mar;(384):144-52. doi: 10.1097/00003086-200103000-00017.
- Background: PubMed 22547920Burns SA, Mintken PE, Austin GP, Cleland J. Short-term response of hip mobilizations and exercise in individuals with chronic low back pain: a case series. J Man Manip Ther. 2011 May;19(2):100-7. doi: 10.1179/2042618610Y.0000000007.
- Background: PubMed 15928561Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
- Background: PubMed 22749295Cleland JA, Whitman JM, Houser JL, Wainner RS, Childs JD. Psychometric properties of selected tests in patients with lumbar spinal stenosis. Spine J. 2012 Oct;12(10):921-31. doi: 10.1016/j.spinee.2012.05.004. Epub 2012 Jun 28.
- Background: PubMed 11040847Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test-retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc. 2000 Oct;75(10):1002-7. doi: 10.4065/75.10.1002.
- Background: PubMed 19119380Ellis RF, Hing WA. Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther. 2008;16(1):8-22. doi: 10.1179/106698108790818594.
- Background: PubMed 9630153Fritz JM, Delitto A, Welch WC, Erhard RE. Lumbar spinal stenosis: a review of current concepts in evaluation, management, and outcome measurements. Arch Phys Med Rehabil. 1998 Jun;79(6):700-8. doi: 10.1016/s0003-9993(98)90048-x.
- Background: PubMed 20227646Genevay S, Atlas SJ. Lumbar spinal stenosis. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):253-65. doi: 10.1016/j.berh.2009.11.001.
- Background: PubMed 26917940Gilbert KK, Roger James C, Apte G, Brown C, Sizer PS, Brismee JM, Smith MP. Effects of simulated neural mobilization on fluid movement in cadaveric peripheral nerve sections: implications for the treatment of neuropathic pain and dysfunction. J Man Manip Ther. 2015 Sep;23(4):219-25. doi: 10.1179/2042618614Y.0000000094.
- Individual participant dataSharing planned: No. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reid D Gehring, DPT principal investigator
Texas Tech University Health Sciences Center
Jean-Michel Brismee, ScD study chair
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy intervention in people with Lumbar Spinal Stenosis, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Swiss Spinal Stenosis Questionnaire (time frame: Baseline, 3-6 weeks, 3-6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03368638, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.