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

Official title

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

Overview

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 recruitment rate for complete and incomplete SCI [Time frame: 6 months post-intervention]
• Attrition rates in Qigong and Manage My Pain app group. [Time frame: 6 months post-intervention]
• intervention adherence [Time frame: 6 months post-intervention]
• the frequency of use of the Manage My Pain app (recommended daily check in) [Time frame: 6 months post-intervention]
• Feasibility of adhering to the collection of quantitative measure 1 [Time frame: 6 months post-intervention]
• Feasibility of adhering to the collection of quantitative measure 2 [Time frame: 6 months post-intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 3 centers

• University of Miami — Miami
• University of Minnesota — Minneapolis
• University of Texas - Rio Grande Valley — Harlingen

Publications

• 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

Identifiers

NCT: NCT06140355 · PT-2023-32452

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗