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NCT Number: NCT06140355

HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qigong

Behavioral

a Qigong introduction class and a 12-week remote Qigong intervention, with a 6-month follow-up

Daily 2 min pain management survey

Behavioral

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 outcomes

  1. recruitment rates

    Time frame: 6 months post-intervention

    The proportion of potential participants contacted who agreed to participate

  2. the recruitment rate for complete and incomplete SCI

    Time frame: 6 months post-intervention

    Ratio of complete/incomplete SCI.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Van de Winckel, PhD, MSPT, PT

CONTACT

[email protected]

612-625-1191

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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