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

NCT ID: NCT06140355

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Qigong

Intervention Type: BEHAVIORAL

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

Active comparison group

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

Group Type: ACTIVE_COMPARATOR

Daily 2 min pain management survey

Intervention Type: 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.

Interventions

Qigong

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Van de Winckel, PhD, MSPT, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Miami

Miami, Florida, United States

Site Status: NOT_YET_RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

University of Texas - Rio Grande Valley

Harlingen, Texas, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Ann Van de Winckel, PhD, MSPT, PT

Role: CONTACT

avandewi@umn.edu

612-625-1191

Facility Contacts

Leslie Morse

Role: primary

Van De Winckel Van

Role: primary

Kelsey Baker

Role: primary

kelsey.baker@utrgv.edu

Other Identifiers

PT-2023-32452

Identifier Type: -

Identifier Source: org_study_id