Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis

NCT06023498 | Active Not Recruiting DMC

• 2 other identifiers: STUDY24010020R01AT012534
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (3)

• Number of participants recruited and retained after 9 months of participation

  Number of participants recruited and retained at each site

  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

  Median number of intervention sessions attended at each site

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

• Rate of missing data

  Percentage of study data that are not entered into data collection system

  Baseline, 3 months, and 9 months

Study Arms (3)

Manual Therapy and Exercise (MTE)

EXPERIMENTAL

Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last \~ 20 minutes. The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes. During the subsequent 6 months, there will be no additional treatment administered. Participants will be asked to continue their HEP.

Other: Manual Therapy and Exercise

MTE Plus MTE Boosters

EXPERIMENTAL

Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last \~ 20 minutes. The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes. During the subsequent 6 months, participants will be asked to return for monthly MTE booster sessions, and they will be asked to continue their HEP.

Other: Manual Therapy and Exercise

MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters

EXPERIMENTAL

Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last \~ 20 minutes. Participants also will be asked to attend weekly intramuscular electroacupuncture (IMEA) sessions administered by a licensed acupuncturist. 30-gauge acupuncture needles will be placed in the muscles of the lower back and buttocks and gentle pulsing electrical stimulation will be delivered for 20 minutes. The home exercise program (HEP) will be identical to that in the MTE and the MTE + Boosters groups. During the subsequent 6 months, participants will be asked to return for monthly MTE and IMEA boosters. Participants also will be asked to continue their HEP.

Other: Manual Therapy and Exercise; Other: Intramuscular Electroacupuncture

Interventions

Manual Therapy and Exercise OTHER

The 20-minute manual therapy procedures will include: * Distraction-manipulation: manually assisted segmental lumbar traction manipulation using a specialized treatment table * Neural mobilization: rhythmic stretches of the sciatic and femoral nerves75 * Hip, sacroiliac and lumbar facet mobilizations to improve joint mobility * Soft tissue mobilization of lumbopelvic and lower extremity muscles using manual pressure over taut bands/myofascial trigger points and post-isometric (contract-relax) stretching techniques.

MTE Plus MTE Boosters; MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters; Manual Therapy and Exercise (MTE)

Intramuscular Electroacupuncture OTHER

As described previously

MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Boston Medical Center: collaborator
• VA Pittsburgh Healthcare System: collaborator
• Syracuse VA Medical Center: collaborator
• Orlando VA Medical Center: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Orlando VA Medical Center

Orlando, Florida, 32827, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Performance-based outcomes measures will be collected by a research coordinator who is masked to participant group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled clinical trial - feasibility study

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 5, 2023
• Study Start: June 11, 2024
• Primary Completion: March 15, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-08

Locations

US (2)