ACTIVE_NOT_RECRUITING

Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis

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Conditions

Lumbar Spinal Stenosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-11
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06023498

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Average pain/discomfort severity \> moderate
  3. * 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)
  4. * Able to commit to 9 months of study participation
  5. * English speaking
  1. * 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)
  2. * Walking capacity over 2 miles
  3. * 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).
  4. * Prior lumbar surgery, because of its negative impact on spinal biomechanics;
  5. * Positive screen for dementia (i.e., Folstein Mini-Mental State Examination);
  6. * Acute medical or psychiatric illness, or active substance abuse that renders the patient incapable of being a reliable study participant;
  7. * Prohibitive communication impairment (e.g., severe hearing or visual impairment)

Contacts and Locations

Study Locations (Sites)

Orlando VA Medical Center
Orlando, Florida, 32827
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-11
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-06-11
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lumbar Spinal Stenosis