Multiple Treatments for Chronic Pain

Overseen By Bill Pearson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edward Via Virginia College of Osteopathic Medicine

Disqualifiers: Pharmaceutical intervention, Functional myofascial pain

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it excludes those seeking pharmaceutical intervention, which might imply a focus on non-drug treatments.

What data supports the effectiveness of the treatment Autonomic Recalibration, Behavior Change Coaching, Multidisciplinary Pain Management (MPM), Integrated Pain Management, Dry Needling, Trigger Point Dry Needling, Intramuscular Stimulation, Osteopathic Manipulative Treatment, OMT, Osteopathic Cranial Manipulative Medicine (OCMM), Osteopathic Manual Medicine (OMM) for chronic pain?

Research shows that multidisciplinary and interdisciplinary approaches, which combine various treatments, are effective for managing chronic pain. These approaches often include a mix of conventional and complementary therapies, tailored to individual needs, and have been shown to improve pain outcomes in diverse settings. ^{1 2 3 4 5}

Is multidisciplinary pain management generally safe for humans?

Multidisciplinary pain management, which includes a variety of non-drug treatments like relaxation training and cognitive-behavioral therapy, is generally considered safe for humans. These approaches are used in military and civilian settings to help manage pain without relying on medications. ^{2 6 7 8 9}

How is Behavior Change Coaching different from other treatments for chronic pain?

Behavior Change Coaching, also known as Multidisciplinary Pain Management, is unique because it combines medical and psychological approaches to address not just the physical aspects of pain, but also the emotional and social factors. This comprehensive approach empowers patients to manage their pain through techniques like relaxation training and cognitive-behavioral therapy, making it different from treatments that focus solely on medication. ^{5 6 10 11 12}

What is the purpose of this trial?

Studies estimate that 30% of people worldwide experience chronic pain. The mechanisms causing this pain can vary: a neuropathic offender, such as nerve compression; a structural offender, such as long-term effects of soft tissue damage and repair; or nociplastic, dysfunctional offenders, such as fibromyalgia. The type of pain experienced influences diagnostic and treatment choice. In theory, there's a significant blending of these pain types within individuals and across patients, leading many specialists to view pain classification as a spectrum. Multidisciplinary pain management (MPM) is a standard model for addressing and treating different mechanisms of chronic pain using multiple interventions from different disciplines. Although many clinics employing these strategies have resulted in positive and clinically effective outcomes, the creation and implementation of such facilities have not been widespread. With increasing focus on psychosocial factors that impact pain in conjunction with structural and biomechanical offenders, a need for a whole-person, integrated approach to chronic pain management is needed. We propose an observational study to gather data that will inform the design, implementation, and operation of such a chronic pain research clinic.

Eligibility Criteria

This trial is for individuals experiencing chronic pain. It aims to observe and collect data on the effectiveness of a multidisciplinary approach, which could inform future chronic pain management clinics.

Inclusion Criteria

I have been experiencing ongoing pain that is not due to a recent injury.

Exclusion Criteria

I am looking for drug treatment.

My muscle pain is due to a normal reaction to injury or disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo multidisciplinary pain management interventions including behavior change coaching, counseling psychology, nutrition, autonomic recalibration, dry needling, and osteopathic manipulative treatment

6 months

Visits at the beginning of each month

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Autonomic Recalibration
• Behavior Change Coaching
• Dry Needling
• Osteopathic Manipulative Treatment

Trial Overview The study tests multiple treatments including behavior change coaching, autonomic recalibration, osteopathic manipulative treatment, counseling psychology, nutrition advice, and dry needling to address various mechanisms causing chronic pain.

Participant Groups

Group I: Osteopathic Manipulative Treatment Experimental Treatment 1 Intervention

Osteopathic Manipulative Treatment

Group II: Nutrition Experimental Treatment 1 Intervention

Nutrition

Group III: Multiple Experimental Treatment 7 Interventions

Multiple

Group IV: Dry Needling Experimental Treatment 1 Intervention

Dry Needling

Group V: Counseling Psychology Experimental Treatment 1 Intervention

Counseling Psychology

Group VI: Behavior Change Coaching Experimental Treatment 1 Intervention

Behavior Change Coaching

Group VII: Autonomic Recalibration Experimental Treatment 1 Intervention

Autonomic Recalibration

Who Is Running the Clinical Trial?

Edward Via Virginia College of Osteopathic Medicine

Lead Sponsor

Trials

24

Recruited

2,700+

Findings from Research

A multidisciplinary treatment approach for chronic pain was effective in reducing pain intensity and functional disability in 110 patients, compared to a control group of 110 patients who did not receive the intervention.

Patients who demonstrated higher levels of acceptance of their condition were more likely to experience significant reductions in pain intensity, suggesting that psychological factors can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary allocation of chronic pain treatment: effects and cognitive-behavioural predictors of outcome. Samwel, HJ., Kraaimaat, FW., Crul, BJ., et al.[2022]

The pilot test of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) at an Army Interdisciplinary Pain Management Center involved 322 active duty patients and showed that those who completed both complementary and integrative medicine (CIM) and functional restoration programs reported greater improvements in pain management outcomes.

The study highlights the effectiveness of using PASTOR to track biopsychosocial aspects of pain treatment, which will help in future analyses of pain therapies for military and veteran populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Pain Assessment Screening Tool and Outcomes Registry in an Army Interdisciplinary Pain Management Center, Lessons Learned and Future Implications of a 10-Month Beta Test. Flynn, DM., Cook, K., Kallen, M., et al.[2018]

An interdisciplinary model for pain management was developed within an integrated health care system, focusing on improving outcomes across various care settings, including acute care and home care.

The model established four key clinical indicators to measure pain management effectiveness, emphasizing strategies like staff accountability and patient education to enhance overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Road to excellence in pain management: research, outcomes and direction (ROAD). Vega-Stromberg, T., Holmes, SB., Gorski, LA., et al.[2019]

The project highlights the effectiveness of using an interdisciplinary team to manage chronic pain, suggesting that collaboration among different healthcare professionals can improve patient outcomes.

Coordinated behavioral health services alongside chronic pain management may enhance the overall treatment experience and effectiveness for patients suffering from chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjoint Sessions With Clinical Pharmacy and Health Psychology for Chronic Pain: Enhancing Participation in Behavioral Management. Bloor, LE., Fisher, C., Grix, B., et al.[2020]

Patients receiving multidisciplinary pain treatment (MPT) showed significant reductions in pain intensity and improvements in psychological well-being, sleep quality, and physical functioning after six months, compared to those on a waiting list.

The study found that simply having a pain diagnosis and management plan from a specialist was not enough for general practitioners to effectively manage severe chronic pain, as the GP group only saw a reduction in short-acting opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic results in chronic, non-malignant pain in patients treated at a Danish multidisciplinary pain center compared with general practice. A randomized controlled clinical trial]. Becker, N., Sjøgren, P., Olsen, AK., et al.[2019]

A multidisciplinary pain management team is the best approach for providing comprehensive treatment to patients experiencing pain, utilizing a biopsychosocial model that addresses various factors affecting pain.

Nonpharmacologic treatments such as relaxation training, biofeedback, hypnosis, imagery, and cognitive-behavioral therapy are recommended by these teams to effectively empower patients in managing their pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidisciplinary approach to nonpharmacologic pain management. Golden, BA.[2018]

A prospective cohort study of chronic non-malignant pain patients showed significant improvements in pain intensity and overall health measures after multidisciplinary pain treatment, with evaluations conducted over multiple periods including a nine-month follow-up.

While the treatment did not significantly reduce overall health care costs, it led to a notable decrease in social transfers, suggesting potential economic benefits from improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic non-malignant pain patients and health economic consequences. Thomsen, AB., Sørensen, J., Sjøgren, P., et al.[2019]

The Improving the Safety of Opioid Therapy (ISOT) intervention aims to reduce harms associated with long-term opioid therapy by educating primary care providers and enhancing the clinician-patient relationship, involving 44 primary care providers and 293 veterans over a 12-month period.

The study employs a cluster-randomized design, where providers received either a workshop on patient-centered opioid therapy or additional support from a nurse care manager, focusing on monitoring opioid-related behaviors and outcomes to ensure safety without negatively impacting pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial. Morasco, BJ., Adams, MH., Maloy, PE., et al.[2021]

In a study of 882 military patients receiving interdisciplinary pain management, more cumulative treatment hours were linked to significant improvements in pain impact, fatigue, and depression, suggesting that longer treatment durations can enhance outcomes.

The analysis indicated that at least 30 hours of interdisciplinary treatment is necessary to see improvements in pain impact, particularly for patients over 40 years old with higher baseline pain levels and mild depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pattern of Cumulative Treatment Hours on Pain Impact and PROMIS Outcomes. Li, H., Flynn, DM., Highland, KB., et al.[2023]

A qualitative evaluation of an interdisciplinary chronic pain coaching program involving 41 Veterans revealed that most participants adopted new self-care practices and reported feeling more in control of their pain management.

While many Veterans experienced significant improvements in their pain management and lifestyle, challenges such as lack of ongoing support and life disruptions hindered their ability to maintain these gains, highlighting the need for continued resources and motivation after the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative evaluation of an interdisciplinary chronic pain intervention: outcomes and barriers and facilitators to ongoing pain management. Penney, LS., Haro, E.[2022]

Chronic pain management requires an interdisciplinary approach that considers biological, cognitive, emotional, behavioral, and social factors, rather than just focusing on physical symptoms.

Recent clinical studies show that interdisciplinary pain management programs are effective and cost-efficient, highlighting the importance of addressing the complex nature of chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary treatment of chronic pain. Gardea, MA., Gatchel, RJ.[2019]

Multimodal pain management is an effective approach for treating complex chronic pain syndromes, integrating medical therapy with various specialized interventions based on the biopsychosocial model.

A position paper from the German Pain Society outlines essential components of multimodal pain management, emphasizing the need for consistency across treatment centers in pain medicine, psychotherapy, exercise therapy, and support from medical professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multimodal pain therapy for treatment of chronic pain syndrome. Consensus paper of the ad hoc commission on multimodal interdisciplinary pain management of the German Pain Society on treatment contents]. Arnold, B., Brinkschmidt, T., Casser, HR., et al.[2021]

References

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

Multidisciplinary allocation of chronic pain treatment: effects and cognitive-behavioural predictors of outcome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Use of the Pain Assessment Screening Tool and Outcomes Registry in an Army Interdisciplinary Pain Management Center, Lessons Learned and Future Implications of a 10-Month Beta Test. [2018]

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

Road to excellence in pain management: research, outcomes and direction (ROAD). [2019]

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

Conjoint Sessions With Clinical Pharmacy and Health Psychology for Chronic Pain: Enhancing Participation in Behavioral Management. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Therapeutic results in chronic, non-malignant pain in patients treated at a Danish multidisciplinary pain center compared with general practice. A randomized controlled clinical trial]. [2019]

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

A multidisciplinary approach to nonpharmacologic pain management. [2018]

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

Chronic non-malignant pain patients and health economic consequences. [2019]

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

Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Pattern of Cumulative Treatment Hours on Pain Impact and PROMIS Outcomes. [2023]

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

Qualitative evaluation of an interdisciplinary chronic pain intervention: outcomes and barriers and facilitators to ongoing pain management. [2022]

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

Interdisciplinary treatment of chronic pain. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Multimodal pain therapy for treatment of chronic pain syndrome. Consensus paper of the ad hoc commission on multimodal interdisciplinary pain management of the German Pain Society on treatment contents]. [2021]