The HAPPINESS Trial: cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Qigong; Behavioral: Daily 2 min pain management survey

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ann Van de Winckel, PhD, MSPT, PT; Phone Number: 612-625-1191; Email: avandewi@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Van De Winckel Van

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18+ years old
• medically stable
• with neuropathic pain above 0 on the Neuropathic Pain Questionnaire (NPQ) scale
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group	Behavioral: Qigong; a Qigong introduction class and a 12-week remote Qigong intervention, with a 6-month follow-up
Active Comparator: Active comparison group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 the Garmin Vivosmart 5 and sending the data through their phone App	6 months post-intervention

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Ann Van de Winckel, PhD, MSPT, PT, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): March 21, 2027

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Pain; Spinal Cord Injuries
• Other Study ID Numbers: PT-2023-32452

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No