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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore different treatments for individuals living with chronic pain, defined as pain persisting beyond a typical healing period. The trial will examine several methods, including behavior change coaching, counseling psychology, nutrition, autonomic recalibration (adjusting the body's stress response), dry needling (using thin needles to relieve muscle pain), and osteopathic manipulative treatment (hands-on techniques to improve movement). The goal is to determine which combination of treatments works best for various types of pain. Individuals experiencing ongoing pain not linked to a recent injury and not seeking medicine-based solutions might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative, non-medicine-based solutions for chronic pain.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this study have varying safety levels based on past experiences with similar therapies.

For Behavior Change Coaching, studies indicate it is generally well-tolerated. This method uses medical and psychological techniques to help manage chronic pain, with no strong evidence of harmful effects. It often aids patients in making lifestyle changes that can improve health.

Dry Needling has a slightly different safety profile. About 20% of treatments may cause mild side effects like bruising, bleeding, and pain. Despite these, it remains a safe and effective way to treat muscle pain.

Osteopathic Manipulative Treatment is generally considered safe. It employs hands-on techniques to improve movement and relieve pain. Most studies suggest it is non-invasive and carries little risk.

Lastly, Autonomic Recalibration is newer, with limited safety data. However, it is a manual therapy aimed at reducing pain by addressing stress responses in the body. Early findings suggest it could be safe, but more research is needed to confirm this.

Overall, these treatments have been used safely in other studies, but mild side effects are possible, especially with Dry Needling. Always consider discussing these options with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic pain because they offer innovative, holistic approaches that differ from conventional options like medication and physical therapy. Behavior Change Coaching focuses on empowering patients to modify habits that contribute to pain, offering a long-term lifestyle solution. Autonomic Recalibration targets the nervous system to help reset the body's response to pain, which is a fresh angle compared to traditional methods. Dry Needling provides a novel way to alleviate muscle tension by directly targeting trigger points, potentially offering quicker relief. These treatments emphasize non-invasive, integrative methods, aiming to provide sustainable pain management without relying solely on drugs.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that different treatments can help manage chronic pain. In this trial, participants may receive one of several treatments. Autonomic Recalibration, one of the treatments under study, can ease pain, improve sleep, and help patients, especially those with muscle pain, regain function. Behavior Change Coaching, another treatment option in this trial, enhances the quality of life for people with chronic pain when combined with other treatments. Dry Needling, also being tested, reduces pain over time, especially in the neck, and increases pain tolerance. Osteopathic Manipulative Treatment, which uses hands-on techniques, effectively addresses muscle and joint issues, reducing pain and improving overall well-being. Each treatment may offer benefits depending on the type and cause of chronic pain. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10871156/

Autonomic Recalibration - PubMed Central - NIH In all cases, AR resulted in pain relief, improved sleep, and restoration of functional abilities. These findings support the potential of AR as ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06603168?term=AREA%5BConditionSearch%5D(Sympathetic%20tone)&rank=9

Study Details | NCT06603168 | Autonomic Recalibration The goal of this clinical trial is to learn if Autonomic Recalibration works to reduce sympathetic dominance to alleviate dysfunctional myofascial pain.

3. bodyworkmovementtherapies.com bodyworkmovementtherapies.com/article/S1360-8592(24)00485-6/abstract

Autonomic recalibration: A pilot study documenting ... Autonomic recalibration: A pilot study documenting mechanistic evidence for a trauma-informed manual therapy for chronic pain. Daniel R. Cawley. Daniel R.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38371140/

A Promising Approach for Alleviating Myofascial Pain ... This retrospective case series introduces autonomic recalibration (AR) as a novel approach for alleviating chronic myofascial pain.

5. researchgate.net researchgate.net/publication/385114016_Autonomic_Recalibration_A_Pilot_Study_Documenting_Mechanistic_Evidence_for_a_Trauma-Informed_Manual_Therapy_for_Chronic_Pain

Autonomic Recalibration: A Pilot Study Documenting ... The McKenzie method showed strong outcomes in both acute and chronic LBP, especially in cases involving symptom centralization and high patient engagement. HVLA ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39593555/

Autonomic recalibration: A pilot study documenting ... Autonomic recalibration: A pilot study documenting mechanistic evidence for a trauma-informed manual therapy for chronic pain.

7. mdpi.com mdpi.com/1424-8220/20/2/365

Sensor Technologies to Manage the Physiological Traits of ... This paper reviews different sensor-based approaches applied to the objective evaluation of non-oncological chronic pain.