Osteopathic Manipulative Treatment for Shoulder Pain

Overseen By Caroline Jones

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Infection, Fracture, Rheumatoid arthritis, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether osteopathic manual treatment, a type of hands-on therapy, can safely and effectively reduce shoulder pain in individuals who have had a stroke. Participants will receive either the actual manual treatment or a sham treatment to compare results. It is open to adults who experienced their first stroke in the past 5 years and have shoulder pain on the stroke-affected side. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance post-stroke care.

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 to get a clear answer.

What prior data suggests that osteopathic manual treatment is safe for hemiplegic shoulder pain?

Research has shown that osteopathic manual treatment (OMT) can reduce pain in individuals with joint issues, such as shoulder pain. Studies indicate that most patients tolerate OMT well. Although unwanted effects can occur, the research does not clearly detail them, suggesting that serious issues are rare. Overall, OMT appears to be a safe option for managing shoulder pain, even for those who have experienced a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manual Treatment for shoulder pain because it offers a hands-on, holistic approach that differs from conventional treatments like medication or surgery. Unlike traditional methods, this treatment involves manual manipulation techniques aimed at improving mobility and reducing pain without the use of drugs. This approach leverages the body's natural ability to heal, potentially minimizing side effects associated with pharmaceuticals. Additionally, the use of a sham treatment arm in the study highlights the focus on assessing the true effectiveness of osteopathic manipulation, which could pave the way for more personalized and less invasive pain management strategies.

What evidence suggests that osteopathic manual treatment is effective for hemiplegic shoulder pain?

Studies have shown that osteopathic manipulative treatment (OMT) can help with shoulder pain. Research indicates that OMT, which involves hands-on techniques to move and stretch muscles and joints, may reduce pain and improve shoulder function. A review of several studies found strong evidence supporting its effectiveness for various shoulder issues. In this trial, participants will receive either OMT or a Sham Treatment as a control. Early findings suggest that OMT could be a promising option for managing shoulder pain, even for patients who have experienced a stroke. ^{1 5 6 7 8}

Who Is on the Research Team?

Ashley Mohan, DO

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

Adults who've had their first stroke within the last 5 years, resulting in shoulder pain on the affected side. They must be over 18 and have had a specific type of stroke (right middle cerebral artery, brainstem, or subcortical). Those with prior shoulder pain, visual neglect issues, inability to consent, severe health conditions, infections needing antibiotics, active cancer or rheumatoid arthritis can't join.

Inclusion Criteria

I have shoulder pain on the same side as my stroke.

My stroke was in the right side of my brain, brainstem, or was a deep or bleeding stroke.

I was diagnosed with my first stroke within the last 5 years.

Exclusion Criteria

I have a fracture in the area that needs treatment.

I have an open wound in the area that needs treatment.

You have trouble paying attention to things on one side of your vision, as shown by a special test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either osteopathic manual treatment or a sham treatment each week

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manual Treatment
• Sham Treatment

Trial Overview

The trial is testing if osteopathic manual treatment (OMT) helps reduce shoulder pain and improve arm function in stroke patients compared to a sham treatment. Participants will receive either real OMT or sham therapy weekly for about 6 weeks to see which is more effective.

How Is the Trial Designed?

Group I: Osteopathic Manual Treatment Experimental Treatment 1 Intervention

Group II: Sham Treatment Arm Placebo Group 1 Intervention

Osteopathic Manual Treatment is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Osteopathic Manual Treatment for:

• Musculoskeletal pain
• Back pain
• Headaches
• Arthritis
• Post-stroke rehabilitation

Approved in European Union as Osteopathic Manipulative Treatment for:

• Musculoskeletal disorders
• Neurological conditions
• Digestive issues
• Respiratory problems

Approved in Canada as Osteopathic Manual Treatment for:

• Chronic pain management
• Sports injuries
• Postural problems
• Stress relief

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

A survey of 491 first- and second-year osteopathic medical students revealed that a strong majority (76%-95%) agree with osteopathic philosophy, particularly those with prior exposure to osteopathic manipulative treatment (OMT).

Students' intentions to use OMT in their future practice were influenced by their reasons for choosing osteopathic medicine, with those motivated by a general desire to be a physician showing less agreement with osteopathic principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic medical students' beliefs about osteopathic manipulative treatment at 4 colleges of osteopathic medicine. Draper, BB., Johnson, JC., Fossum, C., et al.[2022]

Between 2000 and 2019, the utilization of osteopathic manipulative treatment (OMT) among Medicare beneficiaries decreased by 24.5%, indicating a decline in this noninvasive treatment option despite its established benefits.

The decrease in OMT usage is likely linked to lower reimbursement rates for OMT services, which may have disincentivized physicians, alongside a reduction in residency programs offering OMT training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization and reimbursement trends of osteopathic manipulative treatment for Medicare patients: 2000-2019. Starr, EG., Smith, JF., Hanson, RB., et al.[2023]

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]

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]

A study involving 668 patients across 11 clinics showed that osteopathic manual treatment (OMT) is frequently used for musculoskeletal issues, with techniques like cranial and myofascial release being the most common.

The research highlights that patient demographics, such as age and sex, influence the likelihood of receiving specific OMT techniques, indicating a tailored approach in osteopathic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study. Licciardone, JC., Kearns, CM., King, HH., et al.[2014]

A survey of 313 MD students revealed that only 31.1% were familiar with osteopathic manipulative treatment (OMT), but 82.1% expressed interest in a 2-week elective course on OMT, indicating a significant demand for education in this area.

Students who had prior exposure to OMT, such as observing it in clinical settings or having family treated by DO physicians, showed higher interest in learning about OMT, suggesting that familiarity may enhance interest in integrating OMT into their future practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and interest in osteopathic manipulative treatment in allopathic medical students. Darby, A., Parascando, JA., Lipinski, M., et al.[2023]

In a study involving 400 participants with nonspecific low back pain, standard osteopathic manipulative treatment (OMT) showed a statistically significant but small reduction in activity limitations compared to sham OMT at 3 months, with a mean difference of -3.4 points on the Quebec Back Pain Disability Index.

Despite the small effect size, the clinical relevance of the improvement is uncertain, and both treatment groups reported similar rates of serious adverse events, indicating that OMT is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. Nguyen, C., Boutron, I., Zegarra-Parodi, R., et al.[2022]

A systematic review of 11 studies involving 1,015 chronic noncancerous pain patients found that osteopathic manual therapy (OMTh) had similar rates of all-cause dropouts (ACD) compared to control interventions, indicating it is generally well tolerated.

The analysis revealed that there were no significant differences in dropouts due to adverse effects (AEs) between OMTh and other treatments, suggesting that OMTh is a safe option for managing chronic pain, although more detailed reporting on AEs is needed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dropout associated with osteopathic manual treatment for chronic noncancerous pain in randomized controlled trials. Rehman, Y., Ferguson, H., Bozek, A., et al.[2021]

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 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 of 29 elderly patients with shoulder issues, those who received osteopathic manipulative treatment (OMT) showed continued improvement in shoulder range of motion (ROM) after 14 weeks, while the control group experienced a decrease in ROM.

Both groups reported significant increases in ROM and decreases in pain during the study, but the OMT group maintained these benefits beyond the treatment period, highlighting the potential long-term efficacy of OMT for shoulder problems in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving functional ability in the elderly via the Spencer technique, an osteopathic manipulative treatment: a randomized, controlled trial. Knebl, JA., Shores, JH., Gamber, RG., et al.[2022]

In a study involving 30 participants, expectations for High Velocity Low Amplitude (HVLA) treatment were significantly higher than for placebo light touch (LT) regarding beliefs about recovery speed and ability to perform daily activities.

The findings suggest that sub-therapeutic ultrasound may serve as a more effective placebo in osteopathic manipulative treatment trials, as it elicited similar expectations to HVLA without providing a true treatment effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient expectations for placebo treatments commonly used in osteopathic manipulative treatment (OMT) clinical trials: a pilot study. Fulda, KG., Slicho, T., Stoll, ST.[2020]

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