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 trial explores how the body naturally manages pain and whether training can enhance this ability, similar to athletic performance training. Participants will engage in exercise sessions designed to induce muscle soreness, known as delayed onset muscle soreness (DOMS), to help researchers study pain variability and management. The trial includes three groups: one with a single exercise session, one with repeated sessions, and one with no exercise for comparison. Ideal participants experience widespread muscle pain but have no other chronic pain conditions or recent joint pain. As an unphased trial, this study allows participants to contribute to groundbreaking research on natural pain management techniques.

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.

What prior data suggests that this pain management training is safe?

Research has shown that certain exercises can cause temporary muscle pain and stiffness, known as delayed onset muscle soreness (DOMS). When someone is not accustomed to a specific exercise or if it's very intense, muscle pain may occur. This pain typically begins 6-12 hours after exercising, peaks between 24-72 hours, and subsides within a week.

Repeating the same exercise helps the body adapt, a phenomenon called the "repeated bout effect." After the first session, muscle pain and soreness decrease with each subsequent session. While initial soreness is normal, it tends to lessen with repeated practice. Overall, these exercises are generally safe, and any soreness is temporary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative strategies for managing musculoskeletal pain through exercise, a method that's not commonly emphasized in standard pain management options like medication and physical therapy. The trial investigates whether single or repeated exercise sessions inducing delayed onset muscle soreness can lead to better pain management outcomes. This approach could reveal new insights into how controlled muscle soreness might positively impact long-term pain relief and recovery, offering a non-pharmacological option that empowers patients to take an active role in their own pain management.

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

This trial will compare different approaches to managing delayed onset muscle soreness (DOMS). Participants in the "Single exposure" arm will complete one exercise session designed to induce DOMS. Research has shown that exercising once can cause muscle soreness, but muscle strength typically returns to normal in about two days. However, using a roller massage after one workout does not seem to aid muscle recovery.

Participants in the "Repeated exposure" arm will complete four exercise sessions, which may help train the body to handle soreness better. This is known as the "repeated bout effect," where muscles become stronger and less sore over time. Studies confirm that this approach helps muscles become more resilient, reducing soreness and damage in the future.

The "Natural history" arm will involve participants completing all sensory testing and imaging without performing any exercise sessions. ^{1 2 6 7 8}

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]

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]

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]

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]

Citations

1. nature.com nature.com/articles/s41598-024-79785-2

Intensity and volume of physical exercise influence DOMS ... The different exercises resulted in lower PPT responses 48 h after exercise and different DOMS reported across the different groups. Skin ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10523143/

Multiple cryosauna sessions for post-exercise recovery of ... Multiple cryosauna was an effective recovery strategy that reduced blood biomarkers and muscle stiffness after exercise-induced muscle damage.

3. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2018.00403/full

A Systematic Review With Meta-Analysis Introduction: The aim of the present work was to perform a meta-analysis evaluating the impact of recovery techniques on delayed onset muscle soreness ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0891584924006944

The repeated bout effect evokes the training-induced ... The repeated bout effect diminishes muscle damage following subsequent eccentric exercise sessions. Initially, eccentric exercise induces muscle ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8549894/

Pathophysiology of Exercise-Induced Muscle Damage and Its ... Extreme or unaccustomed eccentric exercise can cause exercise-induced muscle damage, characterized by structural changes involving sarcomere, cytoskeletal, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12178262/

A Systematic Review and Bayesian Network Meta-Analysis Symptoms typically manifest 6–12 hours post-exercise, peak between 24 and 72 hours, and gradually resolve within 5–7 days.

7. mdpi.com mdpi.com/2077-0383/13/7/2006

Physical Therapies for Delayed Onset Muscle Soreness We will systematically review the current evidence on clinical outcomes (efficacy, safety) of physiotherapy interventions for the treatment of DOMS/EIMD in ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06699186

NCT06699186 | Sleep and Delayed-onset Muscle Soreness Delayed onset muscle soreness (DOMS) represents a phenomenon characterised by a range of symptoms, encompassing varying degrees of muscle stiffness and pain, ...