Clinical trial NCT06140355: The HAPPINESS Trial: cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury
Official title: cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: recruitment rates
timeFrame: 6 months post-intervention
measure: the recruitment rate for complete and incomplete SCI
timeFrame: 6 months post-intervention
measure: Attrition rates in Qigong and Manage My Pain app group.
timeFrame: 6 months post-intervention
measure: intervention adherence
timeFrame: 6 months post-intervention
measure: the frequency of use of the Manage My Pain app (recommended daily check in)
timeFrame: 6 months post-intervention
measure: Feasibility of adhering to the collection of quantitative measure 1
timeFrame: 6 months post-intervention
measure: Feasibility of adhering to the collection of quantitative measure 2
timeFrame: 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Harlingen
country: United States
facility: University of Texas - Rio Grande Valley
state: Texas
Study officials:
affiliation: University of Minnesota
name: Ann Van de Winckel, PhD, MSPT, PT
role: PRINCIPAL_INVESTIGATOR
References: