Osteopathic Manipulative Treatment for Shoulder Pain

Recruiting in Middleton (>99 mi)

Overseen By Janelle Suriaga

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

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 to get a clear answer.

What data supports the effectiveness of the treatment Osteopathic Manipulative Treatment for shoulder pain?

Research shows that osteopathic manipulative treatment (OMT) can help improve shoulder function and reduce pain in elderly patients with shoulder problems, suggesting it may be effective for shoulder pain. ^{1 2 3 4 5}

Is osteopathic manipulative treatment generally safe for humans?

Research on osteopathic manipulative treatment (OMT) shows that while adverse events (unwanted effects) can occur, they are not well-defined in terms of how often they happen or how severe they are. There is no clear benchmark for safety, but the treatment is widely used for various conditions. ^{4 6 7 8 9}

How is osteopathic manipulative treatment (OMT) for shoulder pain different from other treatments?

Osteopathic manipulative treatment (OMT) is unique because it involves hands-on techniques to improve movement and reduce pain, focusing on the body's musculoskeletal system. Unlike standard drug treatments, OMT is noninvasive and aims to enhance the body's natural healing processes. ^{1 2 10 11 12}

What is the purpose of this trial?

This study assesses the feasibility and safety of performing osteopathic manual treatment (OMT) for hemiplegic shoulder pain in stroke patients. This study's participants will be adults with a first-time stroke diagnosis in the past 5 years and shoulder pain on the same side affected by stroke. Eligible participants will be placed on study for approximately 6 weeks and given either OMT or a sham treatment each week.

Research Team

Ashley Mohan, DO

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Utilization and reimbursement trends of osteopathic manipulative treatment for Medicare patients: 2000-2019. [2023]

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

Improving functional ability in the elderly via the Spencer technique, an osteopathic manipulative treatment: a randomized, controlled trial. [2022]

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

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study. [2014]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Patient expectations for placebo treatments commonly used in osteopathic manipulative treatment (OMT) clinical trials: a pilot study. [2020]

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. Germany pubmed.ncbi.nlm.nih.gov

Dropout associated with osteopathic manual treatment for chronic noncancerous pain in randomized controlled trials. [2021]

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

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

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

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

10. Germany pubmed.ncbi.nlm.nih.gov

Awareness and interest in osteopathic manipulative treatment in allopathic medical students. [2023]

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

Osteopathic medical students' beliefs about osteopathic manipulative treatment at 4 colleges of osteopathic medicine. [2022]

12. United States 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. [2022]