HAPPINESS: cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury: a feasibility study

NIH R34 grant

HAPPINESS: cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury: A feasibility study.

 

For this study, the University of Minnesota collaborates with the University of Texas-Rio Grande Valley, the Minnesota Veterans Affairs, Duluth rehabilitation centers, and the Spring Forest QigongTM center in Minnesota. 

For the first part of the study, we will organize event meetings, focus groups, and interviews with various spinal cord injury (SCI) stakeholders and adults with SCI of diverse backgrounds (e.g., diverse race/ethnicity, LGBTQ+, veterans, adults living in rural areas, adults in socio-economic distress,…) to ensure that the study in itself and the interventions mentioned below are culturally sensitive. The focus groups and interviews can be held in-person or over Zoom. The study and the interventions will be available in English and Spanish. 

For the second part of the study, we will recruit up to 40 adults with SCI and with neuropathic pain of at least 4/10 as the highest neuropathic pain intensity level in the prior week. We aim to recruit at least 50% of participants of diverse backgrounds. The second part of the study is completely remote. 

Participants will be divided into two groups by chance: 

One group of participants will attend an introduction class over Zoom and then practice the “Five Elements Qigong Healing Movements” at home at least 3 times/week for 40 min for 12 weeks. The video will be accessible through a login and password on the Spring Forest QigongTM website. In addition, each month they will do a Qigong session over Zoom with a certified Qigong Trainer.

The other group will receive a daily 2-minute pain management survey to complete during 12 weeks. 

Participants will receive weekly calls (Zoom is also possible) from Dr. Van de Winckel’s team who will ask about neuropathic pain, adherence to the Qigong practice/pain management, and effects experienced, as well as anything that might have influenced the pain that week.

Before and after the Qigong training/pain management, as well as after a 6-month follow-up with monthly calls, participants will complete some questionnaires over Zoom with Dr. Van de Winckel’s team.

All participants will receive a Fitbit smartwatch and we will acquire the data from the watch during the study. Participants can keep the watch after the study ends. Three weeks before the intervention, the last three weeks of the intervention, and the last three weeks of the 6-month follow-up, participants will complete a 5-minute survey, 4x/day. They receive $1 for each completed survey. When participants complete all components of this second part of the study, they receive $200. 

This study will identify the feasibility of Qigong practice and pain management on neuropathic pain, function, and other assessments important for adults with SCI. The total participation period is about 9-10 months.

Schedule of Events for the clinical trial part

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Schedule of Events for the clinical trial part

Screening and Clinical Testing Visit

  • Consent to participate in the study 
  • Review your demographic information and medication history
  • Complete study-required questionnaires over Zoom 
  • You will receive a Fitbit smartwatch and we will assist in setting it up so we can receive the data during the study

Qigong practice

If you are in this group, you will participate in an introductory Qigong class over Zoom, organized by the Spring Forest QigongTM Center, and receive access to an online video to practice at home, 3 times/week, 40min/session for 12 weeks. In addition, each month you will do a Qigong session over Zoom with a certified Spring Forest QigongTM Trainer. 

At least once a day, you will tap the watch and ensure the data from the watch are uploaded on the Fitbit app on your smartphone. 

You will receive weekly check-in calls to ask about neuropathic pain, pain medication, how the training is going, and what effect from the intervention you perceive in your body. 

After the 12-week intervention, you will complete the same study-required questionnaires over Zoom as you did at the first visit.

You will also complete a 5-minute questionnaire 4x/day for 3 weeks before the start of the intervention and during the last 3 weeks of the intervention. You will receive $1 for each completed survey during those 3 weeks. 

Pain management survey

If you are in this group, you will receive a daily link to a 2-minute pain management survey to complete. You can choose to receive this link via email or text message. 

At least once a day, you will tap the watch and ensure the data from the watch are uploaded on the Fitbit app on your smartphone.

You will receive weekly check-in calls to ask about neuropathic pain, pain medication, how the pain management is going, and what effect from the intervention you perceive in your body. 

After the 12-week intervention, you will complete the same study-required questionnaires over Zoom as you did at the first visit.

You will also complete a 5-minute questionnaire 4x/day for 3 weeks before the start of the intervention and during the last 3 weeks of the intervention. You will receive $1 for each completed survey during those 3 weeks. (You will not receive money for completing the pain management surveys, only for the ones that are sent 4x/day during those 3 weeks).

Follow-up survey

You can continue with your intervention (Qigong or pain management) as often as you like. If you are in the pain management group, you will still receive the survey links but during these 6 months, you can choose how often you want to complete it. We want to know in this phase whether the intervention can change into a habit. 

At least once a day, you will tap the watch and ensure the data from the watch are uploaded on the Fitbit app on your smartphone.

You will receive monthly check-in calls from Dr. Van de Winckel’s team and complete a 5-minute questionnaire 4x/day during the last 3 weeks of the 6-month follow-up. You will receive $1 for each completed survey during those 3 weeks. 

Final visit

After the 6-month follow-up period, you will complete the same questionnaires over Zoom as you did before and after the intervention. You can keep the watch. If you completed all study components, you will receive $200. 

FREQUENTLY ASKED QUESTIONS

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FREQUENTLY ASKED QUESTIONS

What do researchers hope to learn?

Researchers have found that some parts of the brain, related to pain and body awareness, function differently in adults with spinal cord injury and neuropathic pain. We know from our other studies that Qigong practice can help restore some of those brain functions along with pain reduction. Other studies have also demonstrated that pain management helps with dealing with pain. 

We would like to investigate how a 12-week Qigong practice or pain management helps reduce or eliminate neuropathic pain. We also want to know whether the intervention can turn into a habit.

How will participating in this study help?

This research helps us understand if these interventions are feasible in adults with spinal cord injury and neuropathic pain, with at least 50% of people of diverse backgrounds. 

How do I need to be dressed for the Qigong practice?

Loose-fitting clothing would be fine. We recommend you wear clothing in which you are comfortable.

Do I have to take a break from other activities/therapies to participate?

We will have you continue to do your usual activities. We will ask you not to start any other body awareness training (martial arts, dance, yoga, Pilates, Taichi) during the 12 weeks that you practice Qigong or do the pain management survey. You can continue any activities that you were doing beforehand.

What are the characteristics of participants you are looking for?

For the first part of the study, we are recruiting various SCI stakeholders of diverse backgrounds to ensure that our study and interventions are culturally sensitive. 

We recruit participants with SCI with various levels of neuropathic pain but at least a 4/10 in highest pain intensity. Since the clinical part (second part of the study) is completely remote, recruitment is nationwide, from across the United States. 

Participants would not be able to participate in the clinical trial part of the study if they:

  • have cognitive problems
  • are unable to speak or understand instructions
  • have fractures, pressure sores, or other infections that would hinder them from participating in the study
  • have vision problems
  • are already actively doing body awareness training (e.g. martial arts, dance, yoga, Pilates, Taichi)
  • or who do not speak English or Spanish.   

If you are not sure if you are eligible, feel free to contact us.

How will I benefit from participating?

There may be no direct benefit to participating in this study, but you could benefit from the Qigong practice or pain management in terms of pain relief and/or other benefits. In any case, the information from this study may help other people in the future.

Does this cost money to participate?

There is no charge to participate. You will receive $200 after completing all study components in the second part of the study (clinical trial). You will receive $40 if you participate in the focus group or interview (in the first part of the study). 

I'm working full-time/in shifts. Can I practice and do the calls before/after my work?

While we cannot always promise a perfect match, we will do our best to plan our visits around your working schedule. Visits early in the morning, after 5 pm, or during the weekend can be discussed.

Principal Investigator (PI):

Ann Van de Winckel, PhD, MSPT

Interested in Participating?

Contact
avandewi@umn.edu