Pain Management Training for Musculoskeletal Pain

Overseen By Mark D Bishop, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Diabetes, Hypertension, Major psychiatric, others

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

Compensation: Varies

Number of Visits: 5

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This project proposes to understand the sources of pain variability, and demonstrate that pain variability represents fluctuation in natural pain management. The project further proposes to determine if endogenous capacity to modulate pain can be trained to maximize their body's ability to manage pain, much as the way in which athletic performance can be trained.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using any intervention, including medication, for symptoms caused by pain training during the study.

Is pain management training for musculoskeletal pain safe for humans?

The safety of treatments for delayed-onset muscle soreness (DOMS) and related conditions is not well-documented in the available research, as the focus has been more on effectiveness rather than safety. ^{1 2 3 4 5}

How does this pain management training treatment differ from other treatments for musculoskeletal pain?

This pain management training is unique because it focuses on training individuals to manage their musculoskeletal pain, potentially involving techniques like cognitive-behavioral strategies or physical exercises, rather than relying solely on medications or physical interventions like compression garments or cryotherapy. This approach may empower patients to better understand and control their pain through self-management techniques. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael E Robinson, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults with widespread muscle pain who meet the ACR diagnostic criteria and those without any current pain or chronic conditions like IBS. It excludes individuals who've trained their biceps recently, had recent arm pain, used other pain interventions, have metal in their body that affects MRI, certain chronic medical conditions, or are pregnant.

Inclusion Criteria

I have muscle pain in multiple areas, as diagnosed by ACR criteria.

I currently do not have any pain.

I do not have current pain in my wrist, hand, elbow, or shoulder and no chronic pain conditions.

Exclusion Criteria

You have metal in your body that can't be in the MRI machine, or you're pregnant.

I have a chronic condition like diabetes or high blood pressure that could affect my pain perception, kidney function, muscle health, or mental health.

I will not use any treatments for pain other than what the study provides.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single exposure

Participants will complete one exercise session designed to induce delayed onset muscle soreness

1 week

1 visit (in-person)

Repeated exposure

Participants will complete four exercise sessions designed to induce delayed onset muscle soreness in the biceps

4 weeks

4 visits (in-person)

Natural history

Participants will complete all sensory testing and imaging but not perform any exercise sessions

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delayed onset muscle soreness

Trial Overview The study aims to understand why people experience different levels of musculoskeletal pain and if it's possible to 'train' the body to manage this pain better. This involves looking at natural variations in how we handle discomfort and trying out methods to improve this ability.

How Is the Trial Designed?

Group I: Single exposure Active Control 1 Intervention

Participants will complete one exercise session designed to induce delayed onset muscle soreness

Group II: Natural history Active Control 1 Intervention

Participants will complete all sensory testing and imaging but not perform any exercise sessions.

Group III: Repeated exposure Active Control 1 Intervention

Participants will complete four exercise sessions designed to induce delayed onset muscle soreness in the biceps

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

Dehydration during exercise in a hot environment significantly increased delayed-onset muscle soreness (DOMS) and perceived pain compared to euhydrated individuals, indicating that proper hydration is crucial for muscle recovery.

Participants who were dehydrated experienced greater muscle microdamage, as evidenced by higher pain levels and tenderness, suggesting that exercising in heat without adequate hydration can worsen muscle injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dehydration and symptoms of delayed-onset muscle soreness in hyperthermic males. Cleary, MA., Sweeney, LA., Kendrick, ZV., et al.[2020]

The study found that both myelinated Aδ-fibres and unmyelinated C-fibres contribute to mechanical hypersensitivity following lengthening contractions (LC), indicating a complex pain response in delayed onset muscle soreness (DOMS).

Blocking the acid-sensing ion channel ASIC3 with a specific inhibitor (APETx2) significantly reduced mechanical hypersensitivity in muscle, suggesting that ASIC3 could be a promising target for developing new pain relief treatments after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thin-fibre receptors expressing acid-sensing ion channel 3 contribute to muscular mechanical hypersensitivity after exercise. Matsubara, T., Hayashi, K., Wakatsuki, K., et al.[2020]

Delayed-onset muscle soreness (DOMS) is a common issue that can hinder performance after exercise, typically peaking 1 to 4 days post-activity.

The article highlights that while various strategies exist to alleviate DOMS, their effectiveness and safety are often not well understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochrane review: Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. Costello, JT., Baker, PR., Minett, GM., et al.[2019]

Wearing compression garments after inducing delayed-onset muscle soreness (DOMS) can help regulate muscle stiffness, as evidenced by lower stiffness values in the non-compressed muscle compared to the compressed muscle after 60 hours.

However, compression garments did not significantly affect muscle perfusion, soreness, calf circumference, or injury severity, indicating that while they may help with stiffness, they do not improve other common symptoms associated with DOMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Compression Garments on the Development of Delayed-Onset Muscle Soreness: A Multimodal Approach Using Contrast-Enhanced Ultrasound and Acoustic Radiation Force Impulse Elastography. Heiss, R., Kellermann, M., Swoboda, B., et al.[2019]

In a study involving 60 participants, acupuncture did not show any significant improvement in alleviating delayed-onset muscle soreness (DOMS) compared to no treatment, indicating that it may not be an effective remedy for this condition.

The study suggests that the acupuncture methods used may not have targeted the underlying mechanisms of DOMS effectively, and future research should consider alternative approaches like dry needling with adjusted pressure thresholds to better assess efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No Effect of Acupuncture in the Relief of Delayed-Onset Muscle Soreness: Results of a Randomized Controlled Trial. Fleckenstein, J., Niederer, D., Auerbach, K., et al.[2022]

Citations

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

Dehydration and symptoms of delayed-onset muscle soreness in hyperthermic males. [2020]

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

Thin-fibre receptors expressing acid-sensing ion channel 3 contribute to muscular mechanical hypersensitivity after exercise. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Cochrane review: Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. [2019]

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

Effect of Compression Garments on the Development of Delayed-Onset Muscle Soreness: A Multimodal Approach Using Contrast-Enhanced Ultrasound and Acoustic Radiation Force Impulse Elastography. [2019]

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

No Effect of Acupuncture in the Relief of Delayed-Onset Muscle Soreness: Results of a Randomized Controlled Trial. [2022]