CClinicalTrials.gg
RecruitingNCT06088329Updated Nov 18, 2023

Mindful Walking for Adults With Chronic Pain

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

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Pain

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralMindful Walking for Adults with Chronic Pain

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

05

What researchers measure

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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).

  2. 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).

06

Study locations

1 of 1 sites recruiting
  • Clemson University
    Clemson, South Carolina 29631, United States
    • Lu Shi · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT06088329
Lead sponsor
Clemson University
Responsible party
Sponsor
First posted
Oct 18, 2023
Start date
Nov 14, 2023
Primary completion
Dec 6, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 18, 2023

Study contacts

Principal Investigator
Contact
lus@clemson.edu
864-656-0495
Project Organizer
Contact
kmegget@clemson.edu
864-986-4077
Lu Shi
principal investigator · Clemson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion