Mindful Walking for Adults With Chronic Pain

November 14, 2023 updated by: Clemson University

Mindfulness Walking for Adults With Chronic Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Principal Investigator
  • Phone Number: 864-656-0495
  • Email: lus@clemson.edu

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Clemson, South Carolina, United States, 29631
        • Recruiting
        • Clemson University
        • Contact:
          • Lu Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindful Walking
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
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).
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
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).
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
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).
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
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindfulness inventory
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).
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).
Perceived intervention effectiveness of pain change
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 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clemson University

Investigators

  • Principal Investigator: Lu Shi, Clemson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

December 6, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2023-0240

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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