CompletedNot Applicable

Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis

United States60 participantsStarted 2024-06-11

Plain-language 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 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 h…

What they're measuring

Number of participants recruited and retained after 9 months of participation

Timeframe: Number of participants recruited at each of two study sites over a period of 12 months (duration of recruitment period) - assessed at 12 months after recruitment starts; number of participants retained at each site after 9 months of study participation

Median number of intervention sessions attended

Timeframe: 3 months (at completion of initial intervention) and 9 months (at completion of follow up period)

Rate of missing data

Timeframe: Baseline, 3 months, and 9 months

Trial details

NCT IDNCT06023498

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-11

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