Improving treatment for lumbar spinal stenosis with manual therapy and acupuncture

Optimizing Impact of Manual Therapy and Exercise on Lumbar Spinal Stenosis With Neurogenic Claudication: A Multi-Site Feasibility Study

This study is testing if a combination of manual therapy, exercise, and acupuncture can help people with lumbar spinal stenosis feel less pain and walk better without surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 2 sites (Orlando, Florida and 1 other locations)
• Trial ID: NCT06023498 on ClinicalTrials.gov

What this trial studies

This feasibility study aims to prepare for a randomized controlled trial that will evaluate the effectiveness of manual therapy, exercise, and intramuscular electroacupuncture in alleviating pain and enhancing walking ability in patients suffering from intermittent neurogenic claudication due to lumbar spinal stenosis. The study is motivated by the high failure rates of surgical interventions and seeks to provide non-surgical alternatives. Participants will be monitored over a nine-month period to assess the impact of these interventions on their symptoms and functional outcomes.

Who should consider this trial

Good fit: Ideal candidates are older adults experiencing intermittent neurogenic claudication with moderate to severe pain and confirmed lumbar spinal stenosis.

Not a fit: Patients with serious underlying health issues or those who can walk over two miles may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the need for surgical interventions in patients with lumbar spinal stenosis.

How similar studies have performed: Previous studies have shown modest efficacy of manual therapy and exercise for similar conditions, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Orlando, Florida and 1 other locations

• Orlando VA Medical Center — Orlando, Florida, United States (RECRUITING)
• Boston Medical Center — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Debra K Weiner, MD

Conditions: Lumbar Spinal Stenosis