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Behavioral Intervention

Experimental group for Spinal Cord Injury

N/A

Recruiting

Led By Ann Van de Winckel, PhD, MSPT, PT

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-intervention

Awards & highlights

Study Summary

"This trial is studying the use of Qigong, a mind and body approach, to help reduce chronic neuropathic pain in adults with spinal cord injury (SCI). The study found that practicing Q

Who is the study for?

The HAPPINESS Trial is for adults over 18 with spinal cord injury and chronic neuropathic pain who can participate in remote Qigong sessions. Participants need internet access, a computer or smartphone, and must speak English or Spanish. They should be medically stable with measurable neuropathic pain.Check my eligibility

What is being tested?

This trial tests the feasibility of a 12-week remote Qigong program versus daily pain management surveys to manage SCI-related neuropathic pain. It aims to establish if these methods are practical and acceptable, especially among diverse populations including Hispanics, veterans, and rural residents.See study design

What are the potential side effects?

Qigong is generally considered safe but may include mild side effects like muscle soreness or strain due to movement. The daily survey intervention likely has no physical side effects but could potentially cause minor stress or inconvenience.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Attrition rates in Qigong and Manage My Pain app group.

Feasibility of adhering to the collection of quantitative measure 1

Feasibility of adhering to the collection of quantitative measure 2

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental groupExperimental Treatment1 Intervention

adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group

Group II: Active comparison groupActive Control1 Intervention

adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to active comparator group

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Qigong

2010

Completed Phase 3

~1120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,935 Total Patients Enrolled

Ann Van de Winckel, PhD, MSPT, PTPrincipal InvestigatorUniversity of Minnesota

2 Previous Clinical Trials

91 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently open for this clinical trial?

"As per the information on clinicaltrials.gov, this medical study is currently in search of eligible participants. The trial was publicly listed on 3/21/2024 and last modified on 3/28/2024."

Answered by AI

What is the upper limit for the number of individuals enrolled in this clinical investigation?

"Indeed, the details provided on clinicaltrials.gov specify that this particular research study is actively seeking participants. The trial was initially listed on March 21st, 2024 and last revised on March 28th, 2024. They are aiming to recruit a total of 40 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The HAPPINESS Trial: cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury

2024. "The HAPPINESS Trial: cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06140355.

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