Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis
Completed · Not applicable
Conditions studied: Lumbar Spinal Stenosis
In brief
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 surgery that fails to help them 1/3-1/2 the time. The purpose of this multi-site feasibility study is to prepare for the conduct of a randomized controlled trial to test the efficacy of manual therapy, exercise, and intramuscular electroacupuncture in reducing pain and improving walking ability for those with INC, and ultimately limiting the need for surgical referrals.
Key facts
- Study ID
- NCT06023498
- Run by
- University of Pittsburgh
- People needed
- 60
- Starts
- 2024-06-11
- Expected to finish
- 2026-03-11
- Last updated by the study team
- 2026-04-07
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Orlando VA Medical Center — Orlando, Florida, United States
- Boston Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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