Mindful Walking for Adults With Chronic Pain

Chronic Pain Clinical Trial

Official title:

Mindfulness Walking for Adults With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088329
• Other study ID #: IRB2023-0240
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Clemson University
• Contact: Principal Investigator
• Phone: 864-656-0495
• Email: lus[@]clemson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Mindful Walking for Adults with Chronic Pain
Participants identified with chronic pain will complete 6 sessions of mindfulness based walking exercises.

Locations

Country	Name	City	State
United States	Clemson University	Clemson	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Clemson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Primary	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.	Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Primary	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.	Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
Primary	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.	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	Mindfulness inventory	Assess the effect of mindfulness techniques based on survey questions and qualitative responses.	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	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	Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).