OMT + Conservative Therapy for Carpal Tunnel Syndrome

(COMET-AOA Trial)

Overseen By Roland Gazaille, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kettering Health Network

Disqualifiers: Diabetes, Hypothyroidism, Rheumatoid disorders, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate and quantify changes in the elasticity and shear wave modulus (stiffness) of the median nerve in patients diagnosed with mild to moderate carpal tunnel syndrome following osteopathic manipulative therapy.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment OMT + Conservative Therapy for Carpal Tunnel Syndrome?

Osteopathic manipulative treatment (OMT) has been shown to be beneficial for managing pain in various conditions, suggesting it might help with carpal tunnel syndrome as well. Although specific studies on carpal tunnel syndrome are not mentioned, the general effectiveness of OMT in pain management supports its potential use in this condition. ^{1 2 3 4 5}

Is osteopathic manipulative treatment (OMT) generally safe for humans?

Research has shown that osteopathic manipulative treatment (OMT) is generally safe for adults, with studies documenting its safety and efficacy for various conditions. ^{2 3 6 7 8}

How is Osteopathic Manipulative Treatment (OMT) different from other treatments for Carpal Tunnel Syndrome?

Osteopathic Manipulative Treatment (OMT) is unique because it involves hands-on techniques to improve body function and alleviate pain, focusing on the musculoskeletal system, which is different from standard treatments like medication or surgery. It is a holistic approach that aims to enhance the body's natural healing processes. ^{2 3 5 7 9}

Research Team

Roland Gazaille, DO

Principal Investigator

Kettering Health

Eligibility Criteria

This trial is for people with mild to moderate carpal tunnel syndrome, confirmed by recent EMG tests. It's open to those with the condition in one or both hands.

Inclusion Criteria

I have been diagnosed with mild to moderate carpal tunnel syndrome.

Exclusion Criteria

My severe carpal tunnel syndrome has led to muscle loss.

I have an underactive thyroid.

I recently had physical therapy for carpal tunnel syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive osteopathic manipulative therapy and/or conservative treatment for carpal tunnel syndrome

6 weeks

4 visits (in-person) at baseline, 2 weeks, 4 weeks, and 6 weeks

Follow-up

Participants are monitored for changes in nerve elasticity and other outcomes after treatment

2 weeks

1 visit (in-person) at 8 weeks

Treatment Details

Interventions

• Conservative Treatment
• Osteopathic Manipulative Treatment (OMT)

Trial Overview The study measures how a type of physical therapy called osteopathic manipulative treatment (OMT) affects the stiffness and elasticity of the median nerve in patients' wrists compared to standard conservative treatments.

Participant Groups

Group I: Group 1 - OMT Only Experimental Treatment 1 Intervention

Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.

Group II: Group 2 - OMT + Conservative Treatment Active Control 2 Interventions

Will receive Osteopathic manipulative treatment in addition to conservative treatment. Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen. Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.

Group III: Group 3 - Conservative Treatment Only Active Control 1 Intervention

Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen.

Osteopathic Manipulative Treatment (OMT) is already approved in United States, European Union for the following indications:

Approved in United States as Osteopathic Manipulative Treatment for:

• Carpal Tunnel Syndrome

Approved in European Union as Osteopathic Manipulative Treatment for:

• Carpal Tunnel Syndrome

Who Is Running the Clinical Trial?

Kettering Health Network

Lead Sponsor

Trials

20

Recruited

1,700+

American Osteopathic Association

Collaborator

Trials

21

Recruited

3,700+

Findings from Research

A structured clinical curriculum in osteopathic manipulative treatment (OMT) significantly increased the use of OMT among house staff, leading to more patients receiving both osteopathic structural examinations and OMT during hospital care.

The decline in OMT usage among osteopathic physicians, starting as early as medical school, highlights the need for standardized training and documentation to promote the integration of OMT in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a structured curriculum in osteopathic manipulative treatment (OMT) on osteopathic structural examinations and use of OMT for hospitalized patients. Shubrook, JH., Dooley, J.[2018]

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]

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 therapy (OMTh) significantly enhances motor cortical excitability, showing a more pronounced and lasting effect compared to muscle stretching and soft touch interventions, as evidenced by a study involving 12 participants.

The study suggests that OMTh may influence cortical plasticity, which could help explain its effectiveness in managing pain, although the exact physiological mechanisms remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Therapy Potentiates Motor Cortical Plasticity. Ponzo, V., Cinnera, AM., Mommo, F., 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]

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]

A review of medical records from 346 pediatric patients receiving osteopathic manipulative treatment (OMT) found no serious complications, indicating that OMT is a safe treatment option for children.

While 9% of patients experienced minor treatment-associated aggravations (worsening of symptoms), there were no significant differences in outcomes based on gender, suggesting that OMT can be safely administered by trained physicians in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. Hayes, NM., Bezilla, TA.[2006]

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]

References

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

Effects of a structured curriculum in osteopathic manipulative treatment (OMT) on osteopathic structural examinations and use of OMT for hospitalized patients. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

Osteopathic Manipulative Therapy Potentiates Motor Cortical Plasticity. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

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

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

Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. [2006]

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

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