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

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $484,983

## Abstract

Decompressive laminectomy (DL), the most common spinal surgery in older adults, is performed to alleviate
lumbar spinal stenosis (LSS) and reduce associated pain, paresthesias, and/or weakness when walking (i.e.,
intermittent neurogenic claudication - INC). Our recent prospective cohort study of 193 older veterans followed
for 12 months following DL revealed that over 50% of participants did not experience significant functional
improvement. Similar rates of failed surgery have been reported in non-veteran populations. Since the vast
majority of DLs are performed electively, non-surgical treatment is recommended as an initial step. Two clinical
trials have demonstrated modest efficacy of manual therapy and exercise (MTE) for people with INC that was
sustained in one trial, but not in the other. Recent clinical practice guidelines recommend adding acupuncture
as a non-surgical pain management strategy and highlight the need for high quality evidence to support this
recommendation. Our clinical experience and preliminary research data regarding the efficacy of
electroacupuncture (specifically, intramuscular electroacupuncture [IMEA]) in these patients are promising.
Ultimately, we wish to conduct a randomized controlled clinical trial to optimize and sustain the efficacy of MTE
by potentially a) increasing the robustness of the initial response via addition of IMEA and b) its durability via
boosters. This two-site feasibility study will be conducted at Boston Medical Center and the Orlando VA
Medical Center, chosen because of their sociodemographic diversity and prevalence of patients with multiple
comorbidities, characteristics that will ultimately facilitate broad generalizability of study findings. We will
evaluate the feasibility of recruiting, randomizing and retaining participants; fidelity of intervention delivery;
participant adherence to prescribed interventions; and the accuracy and completeness of data collection
procedures. Fifty-six participants (28 per site) with imaging-identified LSS and INC who have not had lumbar
surgery, will be randomized to receive 1) MTE for 3 months (10 sessions over 12 weeks) followed by a 6-
months observation period; 2) MTE for 3 months followed by monthly MTE booster sessions for 6-months; OR
3) MTE + IMEA for 3 months followed by monthly MTE + IMEA for 6-months. The primary outcome (Brigham
Spinal Stenosis questionnaire) will be measured at baseline, 3 months (primary endpoint), 6 and 9 months. We
also will measure community mobility (life space), emotional functioning (PHQ8 and GAD7), pain medications,
and other key parameters relevant to older adults with LSS and INC (e.g., smoking, BMI, medical comorbidity).
Fidelity will be optimized by delivering standardized provider training, conducting regular review of participant-
provider intervention sessions and documentation, and monthly all-site huddles. We also will monitor
participant attendance and home exercise compliance. If we demonstrate feasibility...

## Key facts

- **NIH application ID:** 10904004
- **Project number:** 5R01AT012534-02
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Paul E Dougherty
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $484,983
- **Award type:** 5
- **Project period:** 2023-08-10 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10904004

## Citation

> US National Institutes of Health, RePORTER application 10904004, Optimizing Impact of Manual Therapy and Exercise on Lumbar Spinal Stenosis with Neurogenic Claudication: A Multi-Site Feasibility Study (5R01AT012534-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10904004. Licensed CC0.

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