Manual Therapy + Acupuncture for Lumbar Spinal Stenosis

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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Manual Therapy + Acupuncture for Lumbar Spinal Stenosis?

Research suggests that exercise, a component of the treatment, is effective in reducing pain and disability in patients with lumbar spinal stenosis. Additionally, manual therapy techniques can help improve movement and function in the spine, which may benefit those with this condition. ^{1 2 3 4 5}

Is manual therapy and acupuncture safe for treating lumbar spinal stenosis?

Manual therapy, including spinal manipulation, is generally considered safe, but some people may experience mild to moderate side effects like muscle soreness. Serious adverse events are rare, but they can occur, such as falls during exercise or other unexpected incidents. It's important to discuss potential risks with your healthcare provider before starting treatment. ^{6 7 8 9 10}

How does the treatment of manual therapy and acupuncture for lumbar spinal stenosis differ from other treatments?

This treatment combines manual therapy, which helps improve spinal movement and muscle function, with acupuncture that uses electrical stimulation to enhance pain relief. This approach is unique because it integrates physical manipulation with electroacupuncture, offering a non-invasive alternative to medication or surgery for managing lumbar spinal stenosis. ^{1 3 4 5 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

I can walk more than 2 miles without assistance.

Positive screen for dementia

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Functional rehabilitation for degenerative lumbar spinal stenosis. [2019]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Acupotomy on Lumbar Spinal Stenosis: A Pragmatic, Pilot, Randomized Controlled Trial. [2023]

6. Scotland pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]

7. Scotland pubmed.ncbi.nlm.nih.gov

Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Pain Management Interventions in Lumbar Spinal Stenosis: A Literature Review. [2023]