User Guide with Prompts for Chronic Pain

No longer recruiting at 1 trial location

Overseen By Julie Postma, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Disqualifiers: Medical, psychological conditions, planned surgery

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether people with chronic pain achieve better results when they receive a User Guide with prompts and weekly reminders, in addition to access to an online pain-management tool. The researchers aim to determine if this combination improves activity, sleep, and pain levels compared to using only the online resource. Ideal participants are U.S. adults who have experienced chronic pain for at least three months, wish to be more active, and can use a Fitbit device. As an unphased trial, this study allows participants to contribute to innovative research that could enhance chronic pain management strategies.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for chronic pain management?

Research has shown that using guides and prompts for online pain management is generally safe. These tools help individuals manage pain without drugs or surgery. As this is not a medical treatment, it does not have known side effects like those from medication or surgery.

Past studies have not linked using a guide with prompts to any negative effects. Similar tools for chronic pain, such as cognitive behavioral therapy (a type of talk therapy), are usually well-tolerated, meaning people generally use them without problems.

In summary, using a guide with prompts is expected to be safe for participants. Past research has shown no evidence of harm, which is reassuring for those considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing chronic pain by combining a User Guide with weekly prompts and an Online Pain-Management Resource. Unlike traditional treatments that often rely on medication or physical therapy, this method emphasizes self-guided learning and regular engagement, empowering patients to take an active role in managing their pain. The intervention's unique feature lies in its focus on education and consistent support, which could lead to more sustainable pain management by addressing both the physical and psychological aspects of chronic pain. This trial aims to uncover whether such a structured, educational approach can enhance pain management outcomes compared to existing methods.

What evidence suggests that the User Guide with prompts is effective for chronic pain?

Research has shown that using a User Guide and receiving weekly reminders with an online pain-management tool can assist adults with chronic pain. In this trial, participants in the intervention group will receive both the User Guide and weekly prompts, while the active-control group will access only the Online Pain-Management Resource without additional guidance. One study found that people using this tool felt less anxious and worried less about their pain. These improvements suggest that extra guidance and regular reminders help users make better use of the pain-management tool. This method could benefit those struggling to manage chronic pain. Overall, early evidence suggests this could be a promising way to improve pain-related outcomes. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who suffer from chronic pain. Participants should be interested in managing their pain using online resources. There are no specific inclusion or exclusion criteria provided, but typically participants must meet certain health conditions and agree to follow the study procedures.

Inclusion Criteria

Interested in increasing activity level

Reside within the US

I have been experiencing chronic pain for at least 3 months.

Exclusion Criteria

Medical or psychological conditions that would prevent study participation

I have no upcoming surgeries that would stop me from joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a User Guide and weekly prompts to use an Online Pain-Management Resource or access to the resource without guidance

8 weeks

Weekly prompts (virtual)

Follow-up

Participants are monitored for changes in activity, sleep, and pain-related measures after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• User guide with prompts

Trial Overview The study is testing if a User Guide with weekly prompts improves activity, sleep, and pain management for those using an Online Pain-Management Resource compared to those who just have access to the resource without additional guidance.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

The intervention group will receive a User Guide and weekly prompts with access to an Online Pain-Management Resource

Group II: Active-control Active Control 1 Intervention

The active-control group receives access to the Online Pain-Management Resource, but no User Guide or prompts.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Published Research Related to This Trial

In a pilot survey of 22 older adults with chronic pain, gastrointestinal adverse drug events (ADEs) were the most commonly reported, with upset stomach being the most frequent issue, affecting 31.8% of participants.

Many older adults self-manage their analgesic-related ADEs without consulting their healthcare provider; 54.5% contacted their physician, while others changed their medication or stopped taking it altogether, highlighting the need for better communication about ADE management in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study. McDonald, DD., Coughlin, S., Jin, C.[2019]

In a 5-year study at a Finnish tertiary hospital, the Global Trigger Tool (GTT) identified 53 adverse drug events (ADEs) among 834 patient records, indicating a rate of 13 ADEs per 1000 patient-days and affecting 6% of patients.

The study found that as the number of medication-related triggers increased, so did the likelihood of experiencing an ADE, suggesting that the GTT medication module is useful for detecting potential risks, although modifications could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Global trigger tool as a medication safety tool for adverse drug event detection-a cross-sectional study in a tertiary hospital. Valkonen, V., Haatainen, K., Saano, S., et al.[2023]

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06804239

Improving Activity in Adults With Chronic Pain With Online ... A randomized controlled study will test whether adults with chronic pain have improved outcomes when receiving a User Guide and weekly prompts for a newly ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7974758/

User Engagement and Clinical Impact of the Manage My ... The use of MMP by patients with chronic pain is associated with engagement and improvements in self-reported anxiety and pain catastrophizing.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1524904223001601

Utilization of Methods for Pain Treatment and Management ... The most used pain treatment methods were passive approaches, ie, rest (60%), distractions (53%), non-prescribed medicine (49%), and prescribed medicine (44%).

4. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/chapters/conduct/real-world-evidence-patient-reported-outcomes-pros/nih-heal-fda-and-other-core-outcome-sets/

NIH HEAL, FDA, and Other Core Outcome Sets Core outcome sets have been developed for different domains to help standardize outcome reporting in clinical trials.

5. hhs.gov hhs.gov/sites/default/files/pain-mgmt-best-practices-draft-final-report-05062019.pdf

Pain Management Best Practices Inter-Agency Task Force ... A list of various types of procedures including trigger point injections, radiofrequency ablation, cryoneuroablation, neuro-modulation and other ...

6. pharmacy-nutrition.usask.ca pharmacy-nutrition.usask.ca/mac/documents/ucpc/chronic-pain-toolkit.pdf

CHRONIC PAIN TOOLKIT - College of Pharmacy and Nutrition With information on over 275 products, each specific page features information on the herb's known or suspected mechanism of action, most common reasons for use ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10088173/

COMMunity of Practice And Safety Support for Navigating ... Safety protections will be strengthened through an ergonomic self-assessment and vouchers for purchasing ergonomic tools. Educational content ...

8. va.gov va.gov/painmanagement/docs/cbt-cp_therapist_manual.pdf

Cognitive Behavioral Therapy for Chronic Pain (DoD) Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. ... Australian WHOQOL instruments: User's manual and interpretation guide ...

9. dam.assets.ohio.gov dam.assets.ohio.gov/image/upload/takecharge.ohio.gov/healthcare-professionals-toolkit/BHIW_TC_Ohio-Pain-Management-Toolkit_06212024.pdf

Ohio Pain Management Toolkit: The CDC Guidelines state: “when prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine ...