Pain Control for Pain Management

(VCAM Trial)

Overseen By Vivek Sagar, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Must not be taking: CNS medications

Disqualifiers: Depression, Bipolar, Seizure, Stroke, others

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

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how control over pain and the environment influences pain perception and anxiety levels. It investigates how different settings, such as feeling safe or lacking control over a threat, alter the brain and body's response to pain. Participants will perform tasks in various virtual contexts to assess their performance when they have control over pain (Pain Controllability Manipulation) versus when they do not (Pain Threat Manipulation). This study suits individuals without a history of mental health issues or chronic pain, who can tolerate pain tests, and can participate in tasks like reading in English. As an unphased trial, it offers participants the chance to contribute to foundational research that could shape future pain management strategies.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that affect the central nervous system or are used for neurological or psychiatric treatment.

What prior data suggests that these manipulations are safe for participants?

Research has shown that controlling pain can make it feel less intense and unpleasant. In studies with healthy volunteers, when participants felt they could manage the pain, it often became less severe. However, this sense of control did not always completely change their pain experience.

Regarding pain threats, past research suggests that understanding and evaluating these threats can aid in better pain management. Uncontrolled pain might lead to worse physical and mental health.

These findings suggest that the treatments under study, which focus on how control and perceived threats affect pain, are generally safe. They aim to explore how pain and anxiety interact with different environments and personal control. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial's approach because it explores how different perceptions of pain controllability and threat can influence pain management. Unlike standard treatments that typically involve medications or physical therapies, this method focuses on altering the mental context in which pain is experienced. By manipulating the sense of control and perceived threat, it aims to provide a non-invasive way to manage pain, potentially reducing the need for drugs and their side effects. This innovative approach could offer a new dimension in pain management by leveraging the brain's ability to modify its response to pain.

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

This trial will explore how different psychological factors, such as the sense of control over pain, affect pain perception. Studies have shown that when people feel they have control over their pain, it bothers them less, even if the pain's intensity remains unchanged. Research indicates that a sense of control alters how the brain processes pain, making it feel less unpleasant. When people feel in control, their suffering from pain can decrease, even if the pain itself remains constant. This suggests that feeling in charge during painful situations can help manage pain more effectively. Understanding how control affects pain could lead to improved pain management strategies that focus on these psychological factors. Participants in this trial will experience different virtual contexts to assess how pain controllability and threat perception influence their pain experience. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals without heart disease, high blood pressure, severe asthma, chronic pain conditions like fibromyalgia or Raynaud's, psychiatric diagnoses such as depression or bipolar disorder, recent seizures or strokes. Participants should not have migraines (15+ headache days a month), be on CNS-affecting drugs for neurological/psychiatric issues, have substance abuse history within six months, and must not be pregnant nor have MRI contraindications.

Inclusion Criteria

I can read and speak English fluently.

I have no history or current diagnosis of depression, bipolar disorder, or any psychiatric condition.

I haven't had seizures, strokes, or major neurological issues in the last 10 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1.5 hours

1 visit (in-person)

Familiarization and Baseline Assessment

Participants undergo pain calibration and familiarize themselves with virtual contexts without any pain.

1.5 hours

1 visit (in-person)

Threat Learning and Controllability Manipulation

Participants learn to navigate virtual rooms with varying pain contingencies and perform tasks in an MRI scanner.

1 hour

1 visit (in-person)

Extinction

Participants experience uncontrollable pain in all rooms to assess spontaneous extinction and memory persistence.

1.5-2 hours

1 visit (in-person)

Reversal and Generalization

Participants undergo reversal of threat conditions and are introduced to novel contexts.

1.5-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main sessions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pain Controllability Manipulation
• Pain Threat Manipulation

Trial Overview The study explores how control over pain and the type of environment affects pain perception, anxiety levels, physiological responses to stressors and cognitive performance including memory retention. It examines if controlling pain in different contexts changes the intensity felt by participants even when the actual stimulus doesn't vary.

How Is the Trial Designed?

Group I: Contextual learning Experimental Treatment 2 Interventions

All participants complete trials in three virtual contexts (safe, controllable threat, uncontrollable threat), with pain controllability and task performance assessed across all conditions in a randomized within-subject design.

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6344140/

Impact of controllability on pain and suffering - PMC Studies in healthy volunteers showed that controllable situations reduce pain intensity and unpleasantness; however, controllability did not always change pain ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1364661324002572

How control modulates pain We describe the neurobiological underpinnings of how control affects pain processing in studies using different types of control.

3. tandfonline.com tandfonline.com/doi/full/10.1080/08870446.2025.2497417

Illness and treatment beliefs and health outcomes in ... Findings identify belief-based correlates of pain-related outcomes and provide formative evidence to guide pain management intervention strategies. Future ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-015-0632-0

Prediction of pain outcomes in a randomized controlled trial of ... Prediction of pain outcomes in a randomized controlled trial of dose–response of spinal manipulation for the care of chronic low back pain.

5. researchgate.net researchgate.net/publication/328498321_Impact_of_controllability_on_pain_and_suffering

Impact of controllability on pain and suffering Results Controllability selectively reduced the experience of pain-related suffering, but did not affect pain intensity or pain unpleasantness. This effect was ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1524904223000619

Review Article Effect of Pain Education Interventions on ... Patient-reported outcomes include pain intensity, pain-related functional impairment, side-effects, and satisfaction, while clinical outcomes include ...

7. academic.oup.com academic.oup.com/painmedicine/article/17/4/692/2584074

The Perceived Control Over Pain Construct and Functional ... Belief in one's ability to control pain is a significant predictor of health outcomes and is related to improved functional status. The purpose of this study ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejp.1775

Perception of repeated pain relief with controllable and ... In sum, the present results show that perceived pain relief increases with repeated pain repetitions and that this pain relief was perceived as ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11513809/

Clinical pain management: Current practice and recent ... The risk ratio for at least 50% pain relief after 6 to 12 weeks of treatment was 1.1 (95% CI 1.01–1.2) for treatment compared to placebo, with an NNT of 6.9 (95 ...