Improving treatment for lumbar spinal stenosis with manual therapy and acupuncture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dweiner@pitt.edu
• Phone: 4124016811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.