An interventional study of Mindful Walking for Adults with Chronic Pain in Chronic Pain, sponsored by Clemson University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Clemson University · Not applicable, Interventional, and Supportive care
Both mindfulness-based interventions and light physical activity have been shown as effective in reducing the burden of chronic pain. This proposed intervention, mindful walking (MW), is a combination of physical activity and mindfulness-based intervention aimed at reducing pain with a non-pharmacological approach. In MW, mindfulness-based instructions emphasized acknowledging arising thoughts, feelings, and/or emotions without judgment or emotional reaction and to "simply return their attention back to the footstep" sensation whenever such discursive events occur. Furthermore, subjects will be taught that perceived sensory and affective events were "momentary" and "fleeting" and do not require further interpretation or evaluation.
Specifically, our proposed MW intervention will focus on the following:
The anticipation is to include thirty patients in Clemson South Carolina with chronic pain without any prior meditative experience (diabetes patients with neuropathic pain, prostate cancer patients with postoperative pain, etc.) into our study.
Eligible participants will then complete 6 sessions of mindful walking across 6 weeks. Each weekly session will last approximately 60 minutes and will be conducted outdoors (weather pending). Mindful walking is a practice of becoming aware of one's surroundings and internal feelings while moving. When practicing walking mindfully, one focuses his/her attention on the sensations in the body with each step, paying close attention to the breath. The mindful walking sessions are intended to provide therapeutic techniques based on achieving a state of mind that focuses one's awareness on the present moment while acknowledging and accepting one's thoughts/feelings. Sessions will be led by a certified instructor to follow mindfulness practices with the incorporation of walking for adults with chronic pain.
At the end of the sessions, participants will be randomly selected using a random number generator to participate in an informal interview session. This is an opportunity for participants to tell us about their experiences in the program and how mindful walking has impacted their chronic pain. The interview will take about thirty minutes of their time.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Clemson University is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All participants will belong to the experimental mindful walking arm for our single arm feasibility study.
Behavioral: Mindful Walking for Adults with Chronic Pain
Participants identified with chronic pain will complete 6 sessions of mindfulness based walking exercises.
Pain Intensity
Measure participants perceived level of pain using validated scales Brief Pain Inventory for pain level 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Time frame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Unpleasantness of the pain
Understand participants perceived level of pain using questionnaire Brief Pain Inventory for pain level 0 meaning no pain and 10 meaning pain as bad as you can imagine and qualitative responses.
Time frame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Pain-related functional scale
Measure participants perceived level of pain using validated scales for pain level (Visual Pain scale 0 meaning no pain and 10 being the worst pain.
Time frame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Pain-related quality of life
Understand participants perceived level of pain using validated scales for pain level (Visual Pain scale Pain scale 0 meaning no pain and 10 being the worst pain. Also use qualitative data responses.
Time frame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Mindfulness inventory
Assess the effect of mindfulness techniques based on survey questions and qualitative responses.
Time frame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Perceived intervention effectiveness of pain change
Perceived intervention effectiveness of pain change will be assessed with a Visual Analogue Scale (VAS) ("0" = not effective at all; "10"= most effective imaginable, for each intervention session's assigned intervention
Time frame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Started Nov 2023 (actual). Primary completion is estimated for Dec 2023, 0 months after the start.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 0 months is below that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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