Mindful Walking for Adults With Chronic Pain

NCT06088329 | Unknown

• 1 other identifier: IRB2023-0240
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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).

• 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 Outcomes (2)

• Mindfulness inventory

  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

  Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).

Study Arms (1)

Mindful Walking

EXPERIMENTAL

All participants will belong to the experimental mindful walking arm for our single arm feasibility study.

Behavioral: Mindful Walking for Adults with Chronic Pain

Interventions

Mindful Walking for Adults with Chronic Pain BEHAVIORAL

Participants identified with chronic pain will complete 6 sessions of mindfulness based walking exercises.

Mindful Walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clemson University: lead

Study Sites (1)

Clemson University

Clemson, South Carolina, 29631, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lu Shi

  Clemson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

864-656-0495; lus@clemson.edu

Project Organizer

CONTACT

864-986-4077; kmegget@clemson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 18, 2023
• Study Start: November 14, 2023
• Primary Completion: December 6, 2023
• Study Completion: December 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)