Spinal Cord InjuriesNCT06140355
cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury
A study testing Qigong and Daily 2 min pain management survey in people with Spinal Cord Injuries, run by University of Minnesota at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Qigong and Daily 2 min pain management survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Aug 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Texas - Rio Grande Valley
Harlingen, Texas, 78539
Kelsey Baker, kelsey.baker@utrgv.edu
- Not yet recruiting
University of Miami
Miami, Florida, 33124
Leslie Morse
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Van De Winckel Van
About this study
Official title: HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study
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
- Being tested
- Qigong, Daily 2 min pain management survey
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongBehavioural
a Qigong introduction class and a 12-week remote Qigong intervention, with a 6-month follow-up
Daily 2 min pain management surveyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group Receives: Behavioral: Qigong |
| Active comparison group | Active comparator | adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to active comparator group Receives: Behavioral: Daily 2 min pain management survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rates
The proportion of potential participants contacted who agreed to participate
Measured: 6 months post-intervention
the recruitment rate for complete and incomplete SCI
Ratio of complete/incomplete SCI.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start20 Aug 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Van de Winckel, PhD, MSPT, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140355
- Sponsor's protocol ID
- PT-2023-32452
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 41259096
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06140355
- Acronym / sponsor ID
- PT-2023-32452
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Qigongadults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group |
| Active comparison group | Active comparator | Behavioral: Daily 2 min pain management surveyadults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to active comparator group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigonga Qigong introduction class and a 12-week remote Qigong intervention, with a 6-month follow-up | Behavioural | Experimental group |
| Daily 2 min pain management surveyCompleting 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. | Behavioural | Active comparison group |
Primary outcome
recruitment rates
Time frame: 6 months post-intervention
The proportion of potential participants contacted who agreed to participate
the recruitment rate for complete and incomplete SCI
Time frame: 6 months post-intervention
Ratio of complete/incomplete SCI.
Attrition rates in Qigong and Manage My Pain app group.
Time frame: 6 months post-intervention
Proportion of people withdrawing from the study in either group. Drop-out due to unrelated reasons will count as part of the general attrition.
intervention adherence
Time frame: 6 months post-intervention
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.
the frequency of use of the Manage My Pain app (recommended daily check in)
Time frame: 6 months post-intervention
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.
Feasibility of adhering to the collection of quantitative measure 1
Time frame: 6 months post-intervention
% Adherence in completing all assessments during the study and in the monthly follow-up phase
Feasibility of adhering to the collection of quantitative measure 2
Time frame: 6 months post-intervention
% Adherence to wearing Fitbit Charge 6 and sending the data through their phone App
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 41259096Van 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.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Van de Winckel, PhD, MSPT, PT principal investigator
University of Minnesota
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong and Daily 2 min pain management survey in people with Spinal Cord Injuries, run by University of Minnesota at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Van de Winckel, PhD, MSPT, PT (612-625-1191, avandewi@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rates (time frame: 6 months post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06140355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.