Clinical trial NCT06088329: Mindful Walking for Adults With Chronic Pain
Official title: Mindfulness Walking for Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Clemson University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Specifically, our proposed MW intervention will focus on the following:

1. Participants will be instructed to focus on the sensations occurring "at the toes or at sole."
2. Participants will be instructed to expand their focus to the "full length of the step," including bodily sensations (e.g., rise and fall of the abdomen and chest).
3. Participants will learn the application of mindfulness principles with the goal for use in everyday life.

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.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years of age or older
* Residents in Oconee and Pickens County
* Individuals with mild to severe chronic pain (i.e., neuropathic pain, postoperative pain, migraine headaches, etc.)
* Individuals must be able to read and understand English (can speak other languages), a translator will not be provided.

Exclusion Criteria:

* Current Mindfulness practice.
* Individuals without chronic pain.
* Individuals who cannot walk without assistance for more than 5 minutes.
* Individuals who do not experience mild to severe chronic pain for at least 3 days per week every week on average.

Primary outcomes:
measure: Pain Intensity
timeFrame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
measure: Unpleasantness of the pain
timeFrame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
measure: Pain-related functional scale
timeFrame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
measure: Pain-related quality of life
timeFrame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Secondary outcomes:
measure: Mindfulness inventory
timeFrame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
measure: Perceived intervention effectiveness of pain change
timeFrame: Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Other outcomes:
Locations:
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
Study officials:
affiliation: Clemson University
name: Lu Shi
role: PRINCIPAL_INVESTIGATOR
References: