Osteopathic Manipulative Therapy for Respiratory Diseases

Overseen By Andrew Ackerman, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Healing fracture, Cancer treatment, Liver disease

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

Compensation: Varies

Number of Visits: 7

Duration: 5 days

68 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is to see Osteopathic Manipulative Therapy, or OMT, can aid in treating patients being seen for respiratory illness and associated symptoms. The hypothesis is that the addition of OMT therapy, alongside other standard care (such as a medication), can help lessen patient symptoms sooner than just other treatment alone, and the duration of the condition will shorten as well.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It mentions that Osteopathic Manipulative Therapy will be added alongside other standard care, which may include medication.

What data supports the effectiveness of the treatment Osteopathic Manipulative Therapy for respiratory diseases?

Research shows that Osteopathic Manipulative Therapy (OMT) can improve outcomes in patients with chronic obstructive pulmonary disease (COPD), such as better lung function and quality of life, when combined with traditional treatments. Additionally, OMT has been found to help with other conditions like pneumonia and recovery after surgery, suggesting it may be beneficial for various respiratory issues. ^{1 2 3 4 5}

Is osteopathic manipulative therapy generally safe for humans?

Osteopathic manipulative therapy (OMT) is a popular treatment, but the safety data is not well-defined, and there is no clear benchmark for patient safety. Some studies have looked into adverse events (unwanted effects), but more research is needed to understand how often and how severe these events are. ^{2 5 6 7 8}

How is osteopathic manipulative therapy different from other treatments for respiratory diseases?

Osteopathic manipulative therapy (OMT) is unique because it involves hands-on techniques to improve respiratory function by addressing physical dysfunctions in the body, such as those in the spine and ribcage, rather than relying solely on medications. This approach aims to enhance breathing mechanics and overall respiratory health, offering a complementary option to traditional drug treatments. ^{2 4 5 9 10}

Research Team

Margaret Moore, DO

Principal Investigator

Physician

Eligibility Criteria

This trial is for patients recently diagnosed with respiratory illnesses like bronchitis, sinus infections, and pneumonia. It's open to those who are receiving standard care for these conditions but have not yet tried Osteopathic Manipulative Therapy (OMT).

Inclusion Criteria

I am between 65 and 100 years old.

Patients being seen for respiratory illness symptoms at Geisinger 65-Forward Buckhorn, PA clinic for care

I was recently diagnosed with an upper respiratory illness, sinusitis, bronchitis, or pneumonia.

Exclusion Criteria

I have or had liver disease.

I am currently healing from a bone fracture.

I am currently undergoing cancer treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard care with or without lymphatic pump OMT therapy for respiratory illness

5 days

2 visits (in-person)

Follow-up

Participants are monitored for symptom severity and duration after treatment

1 year

Electronic survey on day of diagnosis and 5 days later

Treatment Details

Interventions

• Osteopathic Manipulative Therapy

Trial Overview The study tests if adding OMT to usual care improves recovery in respiratory illness patients. The goal is to see if symptoms resolve faster and the overall sickness duration decreases compared to standard treatment alone.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Patients will receive lymphatic pump OMT therapy in addition to other standard care (similar to the control patients, this would be a medication, follow-up instructions, etc.)

Group II: Control Active Control 1 Intervention

Patients in the control group will receive normal standard care, including any prescriptions, follow-up instructions, etc., as given by the provider to help treat their condition.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Findings from Research

In a study involving 25 participants with COPD, four osteopathic techniques (thoracic lymphatic pump with and without activation, rib raising, and myofascial release) were found to cause mild adverse effects on pulmonary function immediately after treatment, with TLP with activation specifically increasing residual volume.

Despite the negative changes in objective pulmonary function measures, most participants reported feeling they could breathe better after the manipulative treatments, indicating a potential disconnect between subjective experience and objective measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The immediate effect of individual manipulation techniques on pulmonary function measures in persons with chronic obstructive pulmonary disease. Noll, DR., Johnson, JC., Baer, RW., et al.[2022]

In a study of 20 patients with severe COPD, combining osteopathic manipulative treatment (OMT) with pulmonary rehabilitation (PR) significantly improved exercise capacity, as measured by the 6-minute walk test, with the OMT group walking an average of 72.5 meters more than the PR-only group.

The OMT group also experienced a significant reduction in residual volume and an increase in FEV1, indicating improved lung function, compared to the PR-only group, highlighting the potential benefits of OMT in managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative treatment effectiveness in severe chronic obstructive pulmonary disease: a pilot study. Zanotti, E., Berardinelli, P., Bizzarri, C., et al.[2012]

In a study of 1310 osteopathic manipulative medicine (OMM) consultations, 47% were for musculoskeletal complaints, with back pain being the most common reason, indicating a strong focus on treating physical pain in hospitalized patients.

A significant portion of consultations (27%) were for newborn feeding difficulties, suggesting that OMT may also be beneficial for pediatric patients, but overall awareness among physicians about its broader applications, including respiratory issues and postoperative recovery, appears limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Medicine Consultations for Hospitalized Patients. Levy, VJ., Holt, CT., Haskins, AE.[2022]

In a pilot study of 32 patients with moderate-to-severe COPD, those receiving osteopathic manipulative treatment (OMT) alongside standard pharmacological therapy showed significant improvements in quality of life and functional tests compared to those receiving only conventional treatment.

The OMT group demonstrated better results in spirometry, the COPD Assessment Test (CAT), and the six-minute walking test (6MWT), indicating that adding osteopathic treatment can enhance the overall management of COPD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of osteopathic treatment in patients with stable moderate-to-severe chronic obstructive pulmonary disease: a randomized controlled pilot study. Buscemi, A., Pennisi, V., Rapisarda, A., et al.[2020]

In a study of 35 elderly participants with chronic obstructive pulmonary disease, osteopathic manipulative treatment (OMT) resulted in significant changes in pulmonary function parameters, including increased airway resistance and decreased forced expiratory flow compared to sham therapy.

Despite subjective reports of improved breathing from 82% of the OMT group, the immediate effects of OMT indicated a worsening of air trapping, suggesting that OMT may not provide the expected benefits in pulmonary function for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effects of osteopathic manipulative treatment in elderly patients with chronic obstructive pulmonary disease. Noll, DR., Degenhardt, BF., Johnson, JC., et al.[2022]

A systematic review of 23 studies found that the majority of adverse events (AEs) following osteopathic manipulative treatment (OMT) were mild, accounting for 98% of reported AEs, indicating a generally safe profile for this treatment.

The study established a patient safety benchmark for post-OMT AEs at 1.0 AEs per 100 post-OMT interval-days, providing a reference point for future research and comparisons in patient safety within osteopathic manipulative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. Unger, MD., Barr, JN., Brower, JA., et al.[2023]

In a study involving 884 patients, the incidence of adverse events immediately after osteopathic manipulative treatment (OMT) was found to be low at 2.5%, with pain or discomfort being the most common complaint.

Women reported experiencing adverse events more frequently than men, suggesting a potential demographic factor in the response to OMT, but overall, the rate of adverse events was lower than those reported in other manual therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. Degenhardt, BF., Johnson, JC., Brooks, WJ., et al.[2022]

Osteopathic manipulative treatment (OMT) shows promising effectiveness in reducing pain and improving function for conditions like acute and chronic non-specific low back pain, chronic non-specific neck pain, and chronic non-cancer pain, based on a review of nine systematic reviews and meta-analyses involving 3740 participants.

There is limited and inconclusive evidence regarding the efficacy of OMT for pediatric conditions, primary headaches, and irritable bowel syndrome, and no adverse events were reported in most studies, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. Bagagiolo, D., Rosa, D., Borrelli, F.[2022]

Osteopathic manual therapy (OMT) techniques, such as thoracic thrust and diaphragm stretching, significantly improved Peak Expiratory Flow (PEF) in healthy individuals, indicating a positive effect on certain aspects of respiratory function.

However, these techniques did not show any improvement in Forced Vital Capacity (FVC) or Forced Expiratory Volume in 1 second (FEV1), suggesting that while OMT can enhance some breathing metrics, it may not overall improve lung health in individuals without pre-existing lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of osteopathic manual techniques (OMT) on respiratory function in healthy individuals. Stępnik, J., Kędra, A., Czaprowski, D.[2020]

Osteopathic manipulative treatment was effectively used to enhance respiratory mechanics in a critically ill patient suffering from acute respiratory failure, demonstrating its potential in emergency settings.

The treatment led to significant clinical improvements, including reduced work of breathing, better arterial oxygenation, and resolution of tachycardia, highlighting its efficacy in critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic philosophy and emergent treatment in acute respiratory failure. Stretanski, MF., Kaiser, G.[2004]

References

1. England pubmed.ncbi.nlm.nih.gov

The immediate effect of individual manipulation techniques on pulmonary function measures in persons with chronic obstructive pulmonary disease. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative treatment effectiveness in severe chronic obstructive pulmonary disease: a pilot study. [2012]

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

Osteopathic Manipulative Medicine Consultations for Hospitalized Patients. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of osteopathic treatment in patients with stable moderate-to-severe chronic obstructive pulmonary disease: a randomized controlled pilot study. [2020]

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

Immediate effects of osteopathic manipulative treatment in elderly patients with chronic obstructive pulmonary disease. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]

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

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]

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

Short-term effect of osteopathic manual techniques (OMT) on respiratory function in healthy individuals. [2020]

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

Osteopathic philosophy and emergent treatment in acute respiratory failure. [2004]