Integrative Therapies for Chronic Pain

(PAIN Trial)

Overseen By Daniel Shaffer, BSBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: David Moss

Must not be taking: Opioids

Disqualifiers: Pregnancy, Active cancer, Dementia, others

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

Compensation: Varies

Number of Visits: 10

Duration: 28 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests integrative therapies such as acupuncture and LASER therapy for managing chronic pain, particularly in military members with back or neck pain. Researchers aim to determine if these treatments can reduce pain and enhance overall well-being without the need for surgeries or strong pain medications like opioids. The trial suits active duty and former military personnel, or their family members, who experience moderate to severe chronic pain and can access care at Nellis Air Force Base. As an unphased trial, it offers a unique opportunity to explore alternative pain management options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that many patients are trying to avoid pain medications, especially opioids, and some have reduced or stopped using them. It's best to discuss your specific situation with the trial coordinators.

What prior data suggests that these integrative therapies are safe for managing chronic pain?

Research has shown that integrative therapies, such as those studied for chronic pain at the Nellis Integrative Medicine Clinic, are generally well-tolerated. For instance, studies on treatments like extracorporeal shockwave therapy (ESWT) and laser therapies have found them safe and effective for relieving various types of pain. One study examined 632 patients with chronic low back pain and found ESWT both effective and safe.

These treatments aim to reduce pain without medications, which can cause side effects. Many patients have experienced improvements in their conditions with few unwanted effects, making integrative therapies a promising option for managing chronic pain safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about integrative therapies for chronic pain because they offer a holistic approach that combines several cutting-edge techniques. Unlike standard pain management, which often relies heavily on medications like opioids or NSAIDs, these therapies include acupuncture, myofascial release, and technologies like microcurrent and LASER therapy. This approach targets pain from multiple angles, potentially reducing the need for pharmaceuticals and minimizing side effects. Additionally, therapies such as extracorporeal shockwave and pulsed electromagnetic therapy are non-invasive, offering a safer alternative for patients seeking pain relief without surgery or drugs.

What evidence suggests that these integrative therapies could be effective for chronic pain?

Studies have shown that combining different therapies can help manage chronic pain. This trial will provide participants with integrative medicine interventions, including extracorporeal shockwave therapy, known to reduce pain and improve muscle and bone issues. Research also indicates that treatments like laser therapy and hands-on therapy can lessen pain. Additionally, pulsed electromagnetic field therapies, another component of this trial, offer a safe and non-invasive way to treat muscle and bone pain. These treatments aim to provide relief without requiring surgery or strong medications. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for active-duty military members and dependents experiencing chronic neuromusculoskeletal pain. It's aimed at those seeking alternatives to surgery or ineffective pain medications, including opioids. Participants should be interested in integrative medicine therapies.

Inclusion Criteria

Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study

I am over 18, connected to the military, and have chronic back or neck pain.

I have experienced significant pain (4/10 or higher) at least twice in the past year, 30 days apart.

Exclusion Criteria

I am scheduled for surgery during the study.

Enrolled in other pain management program (e.g. pain management, PT/OT)

Anticipated Change of station, deployment, retirement from military service, separation from active or reserve military service (includes national guard) or plan to discontinue enrollment at MOMMC in <6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Baseline Assessment and Initial Treatment

Participants complete baseline assessments and receive initial treatment using integrative medicine modalities

1 week

1 visit (in-person or virtual)

Treatment

Participants receive ongoing integrative medicine treatments and complete various patient questionnaires

28 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integrative Therapies

Trial Overview The study evaluates the effectiveness of various integrative therapies like acupuncture, myofascial therapy, microcurrent therapy, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies at the Nellis Integrative Medicine Clinic.

How Is the Trial Designed?

Group I: Integrative Medicine (pre to post treatment) Experimental Treatment 7 Interventions

Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.

Who Is Running the Clinical Trial?

David Moss

Lead Sponsor

Trials

6

Recruited

830+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12565389/

The State of Extracorporeal Shockwave Therapy for ... Extracorporeal shockwave therapy (ESWT) is a standard procedure for the treatment of musculoskeletal disorders due to its ability to reduce pain and promote ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919115011954

Update on the efficacy of extracorporeal shockwave ... We present the current knowledge on shockwave treatments for myofascial pain syndrome. · ESWT is an efficient tool for the treatment of myofascial pain síndrome.

3. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2024/02000/comparative_effectiveness_of_noninvasive.49.aspx

Comparative effectiveness of noninvasive therapeutic... Our findings support that manual therapy, laser therapy, and extracorporeal shock wave therapy could effectively reduce pain intensity, pressure pain threshold,

4. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/shockwave-treatment-a-new-wave-for-musculoskeletal-care/mac-20590258

Shockwave treatment: A new wave for musculoskeletal care Patients who have had FSW or RPW typically report decreased pain initially after treatment because the C-fibers have really been overwhelmed.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7297361/

Electromagnetic Field Therapy: A Rehabilitative ... Electromagnetic fields (EMFs) provide a non-invasive, safe, and easy method to treat pain with respect to musculoskeletal diseases.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12000203/

Extracorporeal Shock Wave Therapy versus laser therapy in ... Recent studies regarding ESWT and laser therapies (HILT and/or LLLT) indicate that both modalities are safe and effective in treating various ...

7. mdpi.com mdpi.com/2075-1729/15/10/1501

The State of Extracorporeal Shockwave Therapy for ... Efficacy and safety of extracorporeal shockwave therapy in chronic low back pain: A systematic review and meta-analysis of 632 patients. J. Orthop. Surg ...

8. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/the-evolving-use-of-extracorporeal-shock-wave-therapy-in-managing-musculoskeletal-and-neurological-diagnoses/mac-20527246

The evolving use of extracorporeal shock wave therapy ... Researchers demonstrated the use of ESWT to reduce pain and promote healing in bone, tendon, ligament and fascia in patients with musculoskeletal disorders.

9. aetna.com aetna.com/cpb/medical/data/600_699/0649.html

Extracorporeal Shock-Wave Therapy for Musculoskeletal ... Extracorporeal shock wave therapy (ESWT) in urology: A systematic review of outcome in Peyronie's disease, erectile dysfunction and chronic pelvic pain.