Manual Therapy + Acupuncture for Lumbar Spinal Stenosis

Not currently recruiting at 1 trial location

Overseen By Debra K Weiner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Dementia, Morbid obesity, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore ways to improve pain management and walking ability in people with lumbar spinal stenosis, a condition that causes pain and difficulty walking. Participants will try different treatments, such as manual therapy, exercise, and intramuscular electroacupuncture, to determine which combination works best without surgery. This trial is ideal for individuals whose pain worsens when walking or standing but eases when sitting. Participants must have evidence of lumbar spinal stenosis from past imaging tests. As an unphased trial, it offers participants the chance to explore non-surgical treatment options and contribute to research that could enhance the quality of life for others with similar conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that manual therapy for the lower back is generally safe, though mild side effects like soreness or discomfort can occur. These effects are common but usually not serious. The risk of a serious issue, such as a worsened disk problem, remains very low, less than 1 in 1,000.

Studies have found that intramuscular electroacupuncture is usually well-tolerated. Although specific data on side effects is limited, acupuncture is often considered low-risk. This therapy uses tiny needles and a small amount of electrical stimulation, which some people might find unusual but not painful.

Overall, both treatments in this study have been used safely in past research. Participants might experience mild discomfort, but serious problems are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for lumbar spinal stenosis because they combine traditional manual therapy with innovative techniques like intramuscular electroacupuncture (IMEA). Unlike standard treatments, which often focus on medication or surgery, this approach enhances flexibility and muscle health through chiropractic movements and a personalized home exercise program. The addition of IMEA, which uses gentle electrical stimulation through acupuncture needles, targets deeper muscle layers, potentially offering more effective pain relief and improved mobility. Furthermore, the integration of booster sessions aims to sustain benefits over time, which is a unique feature compared to conventional treatments.

What evidence suggests that this trial's treatments could be effective for lumbar spinal stenosis?

Research has shown that combining hands-on therapy with exercise can greatly improve symptoms of lumbar spinal stenosis, a condition affecting the lower back. One study found that this combination helped patients walk better and feel less pain. In this trial, participants in the "Manual Therapy and Exercise (MTE)" arm will receive this combination. Adding regular follow-up sessions, as in the "MTE Plus MTE Boosters" arm, appears to enhance these benefits even further.

For those in the "MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters" arm, early results suggest that adding intramuscular electroacupuncture might provide extra pain relief for long-term low back pain. This treatment uses tiny needles and mild electrical pulses to stimulate muscles. Evidence suggests these treatments can effectively manage back pain as alternatives to surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with moderate to severe pain from lumbar spinal stenosis, confirmed by MRI or CT scans. Participants must experience pain that spreads beyond the spine when walking or standing and eases upon sitting. They should be willing to commit to a 9-month study.

Inclusion Criteria

My average pain level is more than moderate.

Able to commit to 9 months of study participation

English speaking

Exclusion Criteria

Red flags indicative of serious underlying illness requiring urgent care

Positive screen for dementia

I can walk more than 2 miles without assistance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive manual therapy and exercise (MTE) for 3 months, with 10 sessions over 12 weeks. Some groups also receive intramuscular electroacupuncture (IMEA).

12 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with some receiving monthly booster sessions.

6 months

Monthly visits (in-person)

Observation

Participants continue their home exercise program without additional treatment.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Intramuscular Electroacupuncture
• Manual Therapy

Trial Overview

The study tests if manual therapy, exercise, and intramuscular electroacupuncture can reduce pain and improve walking in patients with intermittent neurogenic claudication, potentially reducing the need for spinal surgery.

How Is the Trial Designed?

Group I: Manual Therapy and Exercise (MTE) Experimental Treatment 1 Intervention

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.

Group II: MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters Experimental Treatment 2 Interventions

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.

Group III: MTE Plus MTE Boosters Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Orlando VA Medical Center

Collaborator

Trials

3

Recruited

170+

VA Pittsburgh Healthcare System

Collaborator

Trials

36

Recruited

15,900+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Syracuse VA Medical Center

Collaborator

Trials

14

Recruited

1,200+

Orlando VA Healthcare System

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a pilot study involving 34 participants with lumbar spinal stenosis, acupotomy combined with usual care showed significant improvements in pain and disability scores over 12 weeks, indicating its potential effectiveness as a treatment option.

No severe adverse reactions were reported, suggesting that acupotomy is a safe intervention for patients with lumbar spinal stenosis, providing a foundation for future larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Acupotomy on Lumbar Spinal Stenosis: A Pragmatic, Pilot, Randomized Controlled Trial. Lee, JH., Lee, HJ., Woo, SH., et al.[2023]

Nonoperative treatment for lumbar spinal stenosis should focus on both anatomical and biomechanical factors, incorporating a comprehensive approach that includes passive modalities, manual therapy, and patient education.

An active program with flexion-based stabilization exercises, hip mobilization, and proprioceptive training is recommended, but further studies are needed to confirm its effectiveness compared to the natural progression of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional rehabilitation for degenerative lumbar spinal stenosis. Rittenberg, JD., Ross, AE.[2019]

Surgical interventions for lumbar spinal stenosis, such as decompression and vertebral fusion, are generally more effective than non-surgical methods like physical therapy and injections for managing pain.

The review analyzed 24 studies and highlighted that while conservative treatments exist, surgical options, including novel techniques like interspinous spacers and minimally invasive lumbar decompression, provide significant pain relief for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management Interventions in Lumbar Spinal Stenosis: A Literature Review. Malik, KN., Giberson, C., Ballard, M., et al.[2023]

In a comparative trial involving 119 Japanese patients with lumbar spinal stenosis, all three conservative management approaches (medication, exercise, and acupuncture) significantly improved symptom severity after 4 weeks, with acupuncture showing the most notable benefits.

Acupuncture not only led to greater improvements in physical function compared to exercise but also resulted in higher patient satisfaction compared to medication, suggesting it may be the most effective conservative treatment option for LSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of three conservative treatments in patients with lumbar spinal stenosis: lumbar spinal stenosis with acupuncture and physical therapy study (LAP study). Oka, H., Matsudaira, K., Takano, Y., et al.[2022]

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

A scoping review of 98 studies revealed a lack of a common definition or classification system for adverse events following spinal and peripheral joint manipulation, which complicates patient safety efforts.

The review identified various descriptors for adverse events, such as causality and symptom severity, highlighting the need for a standardized approach to improve clarity and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. Funabashi, M., Gorrell, LM., Pohlman, KA., et al.[2022]

A systematic review of 283 reviews on spinal manipulative therapy (SMT) found that while 46% deemed SMT safe, 13% considered it harmful, indicating a significant divide in opinions on its safety.

Serious adverse events (SAEs) associated with SMT, such as stroke and vertebral artery dissection, were reported, with incidence estimates ranging from 1 in 20,000 to 1 in 250,000,000 manipulations, highlighting that some risk is present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. Nielsen, SM., Tarp, S., Christensen, R., et al.[2022]

A physical therapy approach for lumbar spinal stenosis focuses on manual therapy to improve spinal motion and neural mobility, combined with an active exercise program that includes flexion exercises.

Successful treatment outcomes depend on a comprehensive and personalized strategy tailored to each patient's specific needs and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy for lumbar spinal stenosis: a comprehensive physical therapy approach. Rademeyer, I.[2019]

A systematic review of 5 randomized controlled trials found that exercise is an effective intervention for reducing pain and disability in patients with lumbar spinal stenosis (LSS), highlighting its benefits over more invasive treatments.

Exercise also positively impacts psychological factors such as depression and mood disturbances in LSS patients, but further research is needed to identify the most effective types of exercise for symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Exercise on Perceived Pain and Disability in Patients With Lumbar Spinal Stenosis: A Systematic Review of Randomized Controlled Trials. Slater, J., Kolber, MJ., Schellhase, KC., et al.[2020]

In a study involving 241 elderly participants undergoing spinal manipulative therapy (SMT) and exercise for chronic neck pain, 130 reported non-serious adverse events (AEs), highlighting the prevalence of musculoskeletal issues associated with these treatments.

Participants in the supervised exercise group reported three times more AEs compared to those receiving home exercise alone, indicating that while SMT and exercise can be effective, they also carry a risk of AEs that should be considered in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial. Maiers, M., Evans, R., Hartvigsen, J., et al.[2022]

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