Status:
ACTIVE_NOT_RECRUITING
Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Boston Medical Center
VA Pittsburgh Healthcare System
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not infrequently undergo spinal ...
Detailed Description
Decompressive laminectomy (DL), the most common spinal surgery in older adults, is performed to alleviate lumbar spinal stenosis (LSS) and reduce associated pain, paresthesias, and/or weakness when wa...
Eligibility Criteria
Inclusion
- Intermittent neurogenic claudication (INC), defined as pain or discomfort with walking or prolonged standing that radiates beyond the spinal area and is relieved with sitting (ascertained using a structured interview)
- Average pain/discomfort severity \> moderate
- Advanced imaging (e.g., MRI, CT scan, CT-myelogram) evidence of lumbar spinal stenosis (extracted from electronic medical record, or outside report provided by participant; advanced imaging will not be performed as part of our study procedures)
- Able to commit to 9 months of study participation
- English speaking
Exclusion
- Red flags indicative of serious underlying illness requiring urgent care (e.g., fever, change in bowel/ bladder function, sudden severe change in pain, unintentional weight loss, new leg weakness)
- Walking capacity over 2 miles
- Other conditions that significantly impact mobility (e.g., painful conditions such as advanced hip/knee osteoarthritis with pain more severe than INC pain, Parkinson's disease, stroke, vascular claudication, angina pectoris, pulmonary disease, morbid obesity (i.e., BMI \> 40).
- Prior lumbar surgery, because of its negative impact on spinal biomechanics;
- Positive screen for dementia (i.e., Folstein Mini-Mental State Examination);
- Acute medical or psychiatric illness, or active substance abuse that renders the patient incapable of being a reliable study participant;
- Prohibitive communication impairment (e.g., severe hearing or visual impairment)
Key Trial Info
Start Date :
June 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06023498
Start Date
June 11 2024
End Date
July 31 2026
Last Update
October 14 2025
Active Locations (2)
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1
Orlando VA Medical Center
Orlando, Florida, United States, 32827
2
Boston Medical Center
Boston, Massachusetts, United States, 02118