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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group |
|
| Active comparison group | Active Comparator | adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to active comparator group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qigong | Behavioral | a Qigong introduction class and a 12-week remote Qigong intervention, with a 6-month follow-up |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Van de Winckel, PhD, MSPT, PT | Contact | 612-625-1191 | avandewi@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ann Van de Winckel, PhD, MSPT, PT | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Not yet recruiting | Miami | Florida | 33124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41259096 | Derived | 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. |
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| 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. |
|
| 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 |
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
|
| University of Texas - Rio Grande Valley | Not yet recruiting | Harlingen | Texas | 78539 | United States |
|
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D064906 | Qigong |
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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