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

NCT06140355 | Recruiting

• 1 other identifier: PT-2023-32452
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (7)

• recruitment rates

  The proportion of potential participants contacted who agreed to participate

  6 months post-intervention

• the recruitment rate for complete and incomplete SCI

  Ratio of complete/incomplete SCI.

  6 months post-intervention

• Attrition rates in Qigong and Manage My Pain app group.

  Proportion of people withdrawing from the study in either group. Drop-out due to unrelated reasons will count as part of the general attrition.

  6 months post-intervention

• intervention adherence

  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.

  6 months post-intervention

• the frequency of use of the Manage My Pain app (recommended daily check in)

  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 months post-intervention

• Feasibility of adhering to the collection of quantitative measure 1

  % Adherence in completing all assessments during the study and in the monthly follow-up phase

  6 months post-intervention

• Feasibility of adhering to the collection of quantitative measure 2

  % Adherence to wearing Fitbit Charge 6 and sending the data through their phone App

  6 months post-intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: Qigong

Active comparison group

ACTIVE COMPARATOR

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

Behavioral: Daily 2 min pain management survey

Interventions

Qigong BEHAVIORAL

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

Experimental group

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.

Active comparison group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (3)

University of Miami

Miami, Florida, 33124, United States

NOT YET RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

University of Texas - Rio Grande Valley

Harlingen, Texas, 78539, United States

NOT YET RECRUITING

Related Publications (1)

• Van de Winckel A, Zhang L, Lim KO, Morse LR, Woodliff B, Maestre G, Baker K. Changing the Perceived Pain Intensity in Populations With Spinal Cord Injury and With Health Disparities (HAPPINESS): Protocol for a Feasibility Study. JMIR Res Protoc. 2025 Nov 19;14:e82431. doi: 10.2196/82431.

  PMID: 41259096 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Qigong

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ann Van de Winckel, PhD, MSPT, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Van de Winckel, PhD, MSPT, PT

CONTACT

612-625-1191; avandewi@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 20, 2023
• Study Start: August 20, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

US (3)