NCT06140355 · University of Minnesota
HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study
What this study is about
Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Current treatment options are limited (primarily pain medications) with insufficient benefits and significant risks for addiction and adverse effects.
View original scientific description
Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Current treatment options are limited (primarily pain medications) with insufficient benefits and significant risks for addiction and adverse effects. Of the available mind and body approaches, Qigong is the most accessible for adults with SCI with evidence for effectiveness in reducing pain, but there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established. To support our feasibility study, we investigated a 12-week remote Qigong program in adults with SCI and neuropathic pain. We recruited 23 adults with SCI, 18 completed the study, and 12 completed the 1-year follow-up. They practiced Qigong 138% of the required intensity (which was, at least 3x/week with Qigong video through the internet). Their pain was reduced by 44% after 12 weeks of Qigong practice and was still reduced at the 6-week and 1-year follow-up. However, three key elements need to be addressed before performing a larger effectiveness study: (1) feasibility/acceptability of Qigong from adults with SCI of diverse backgrounds; (2) feasibility of the study design with control group); and (3) objective outcome measures. This R34 feasibility study, the HAPPINESS trial (cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury), will expand on our prior study to consolidate feasibility with a rigorous protocol. We will address the following aims: AIM 1. Identify the facilitators/barriers to participating in a Qigong study through focus groups/interviews with stakeholders from diverse backgrounds, defined as Hispanics, veterans, and adults living in rural, underserved areas. AIM 2. Establish the feasibility of study design/methods of the HAPPINESS trial in adults with SCI (at least 50% of diverse backgrounds) through pre-specified targets for recruitment/enrollment, feasibility, and acceptability of design and outcomes. Using a Phase I randomized controlled trial design, 40 adults with SCI-related neuropathic pain will be randomized to 12-week remote Qigong intervention OR a short daily pain management survey that can be completed on phone/iPad/computer + 6-month follow-up. The study results will facilitate a rigorous structure to design larger effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind-body approaches for whole-person health in diverse groups of adults with chronic/neurological disorders.
Interventions
BEHAVIORAL
Qigong
a Qigong introduction class and a 12-week remote Qigong intervention, with a 6-month follow-up
BEHAVIORAL
Daily 2 min pain management survey
Completing one short survey (2 min) daily through your phone or computer (you will get a survey link through email or text), with a 6-month follow-up.
Primary outcome measures
recruitment rates
Time frame: 6 months post-intervention
The proportion of potential participants contacted who agreed to participate
the recruitment rate for complete and incomplete SCI
Time frame: 6 months post-intervention
Ratio of complete/incomplete SCI.
Attrition rates in Qigong and Manage My Pain app group.
Time frame: 6 months post-intervention
Proportion of people withdrawing from the study in either group. Drop-out due to unrelated reasons will count as part of the general attrition.
intervention adherence
Time frame: 6 months post-intervention
the website log times will indicate the date and duration that the video is accessed. From this information, we will collect the number of minutes that they practice. This information will be checked with the self-report during the weekly calls, in which they will report the number of minutes per week they have practiced.
the frequency of use of the Manage My Pain app (recommended daily check in)
Time frame: 6 months post-intervention
Weekly/ monthly check-ins (reporting min/week of practice) to identify facilitators and barriers to practicing Qigong. The website logs time and duration of video access. A Qigong certified instructor will do 1:1 Qigong session with each participant via zoom monthly for quality control/to give guidance.
Feasibility of adhering to the collection of quantitative measure 1
Time frame: 6 months post-intervention
% Adherence in completing all assessments during the study and in the monthly follow-up phase
Feasibility of adhering to the collection of quantitative measure 2
Time frame: 6 months post-intervention
% Adherence to wearing Fitbit Charge 6 and sending the data through their phone App
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18+ years old
- medically stable
- with neuropathic pain 4 or above on the numeric pain rating scale + screened with painDETECT
- willing to participate in a remote Qigong intervention (from any location with internet connection)
- fluent in English or Spanish
- access to the internet and a computer/iPad or smartphone
Exclusion criteria
- uncontrolled seizure disorder
- cognitive impairment and/or communicative disability (e.g., due to brain injury) preventing them from following directions or from learning
- ventilator dependency
- major medical complications
- pressure ulcers hindering prolonged sitting or lying down
- (planning to become) pregnant or planning a major surgery during the study (given study duration, regular Qigong practice, and frequent check-ins)
- regular Tai Chi or Qigong practice in the past 6 months (3x/week or more)
- currently engaged in other rehabilitation programs that would influence outcomes
Where
- Miami, Florida
- Minneapolis, Minnesota
- Harlingen, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations