Back to resultsImmediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
Primary Purpose
Chronic Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body scan meditation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Central Sensitization, Meditation
Eligibility Criteria
Inclusion Criteria:
- Subjects are from a convenience sample of patients seeking physical therapy care from a physician referral or direct-access to a privately owned physical therapy clinic English speaking
- Central Sensitization Inventory > 40
- Subject complains of disproportionate non mechanical unpredictable pattern of pain provocation in response to multiple non-specific aggravating/easing factors
- Pain disproportionate to the nature and extent of injury or pathology
- Strong association with maladaptive beliefs and pain behaviors
- Diffuse, nonanatomic areas of pain and tenderness on palpation
Exclusion Criteria:
- Does not meet the criteria above
Sites / Locations
- Whole Body Health Physical Therapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
10 minute body scan meditation
Arm Description
Participants will be taken through a 10 minute body scan meditation by a physical therapist
Outcomes
Primary Outcome Measures
Global Rating of Change
This is a form the subject fills out rating their overall pain experience after an intervention. The scale is from -7 (Significantly worse to +7 Significantly better) and measures the amount of change the person feels they have experienced.
Pain pressure Threshold
This is a pressure algometer the measures the sensitivity of an area on the body to direct pressure. It measures the amount of pressure that is applied to the subject's body. The clinician will apply pressure to the subject's skin at the tibialis anterior, lumbar paraspinals and upper trapezius muscles on the dominant hand side. The clinician will ask the subject "I want you to tell me the moment the sensation changes from pressure to discomfort and say "STOP". That is the reading/measurement the clinician will take. The outcome is assessing a change in pressure discomfort before the meditation and immediately after the meditation.
Neck Disability Index
This is a questionnaire to measure the amount of disability the subject perceives due to their neck pain.
Oswestry Disability Index
This is a questionnaire to measure the amount of disability the subject perceives due to their back pain
Pain Body Diagram
This is an body image drawing. The subject colors in the area on the image of where they are experiencing pain. This outcome is assessing the location and extent of the area of pain in the body and how it changes with the intervention. The way this is assessed is by dividing the body image drawing into a grid. The body pain diagram consists of an outline of the entire body from anterior and posterior views. An overlay is created dividing the body pain diagram into 45 anatomical regions The overlay is placed over the body pain diagram, and the examiner recorded a score of 1 if pain is indicated and 0 if no pain is indicated in each of the 45 regions. Pain is considered present if any portion of the region was shaded, no matter how small.
Numeric Pain Rating Scale
This is a scale assessing the subjects pain. It is a scale from 0 (no pain) to 10 (being the most severe pain). The subject will be assessed if their pain rating changed from before the intervention to after the intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT05498077
First Posted
August 8, 2022
Last Updated
August 10, 2022
Sponsor
Therapeutic Neuroscience Research Group
Collaborators
Rockhurst University, Evidence In Motion
1. Study Identification
Unique Protocol Identification Number
NCT05498077
Brief Title
Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
Official Title
Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutic Neuroscience Research Group
Collaborators
Rockhurst University, Evidence In Motion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
For patients with chronic pain, how does a 10 minute guided body scan meditation affect pressure pain threshold and extent of pain on a body diagram?
Detailed Description
Patients who present with central sensitization in physical therapy will go through a 10 minute body scan meditation. If patient meets criteria then they will fill out pre-intervention measures including hand dominance, gender identity, duration of pain, work status, pain body diagram, current pain level, previous medication and a neck disability index or an oswestry disability index.
Subject will then be asked what position they feel most comfortable to be led through this body scan meditation.
After the meditation, the participant will fill out another pain body diagram, current pain level, global rating of change and pain pressure threshold.
At this point the study is over and the subject will return to their physical therapy treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Central Sensitization, Meditation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
10 minute body scan meditation
Arm Type
Experimental
Arm Description
Participants will be taken through a 10 minute body scan meditation by a physical therapist
Intervention Type
Procedure
Intervention Name(s)
Body scan meditation
Intervention Description
Subject is placed through a brief body scan meditation to determine whether this intervention affects a person's pain experience
Primary Outcome Measure Information:
Title
Global Rating of Change
Description
This is a form the subject fills out rating their overall pain experience after an intervention. The scale is from -7 (Significantly worse to +7 Significantly better) and measures the amount of change the person feels they have experienced.
Time Frame
Immediately After intervention
Title
Pain pressure Threshold
Description
This is a pressure algometer the measures the sensitivity of an area on the body to direct pressure. It measures the amount of pressure that is applied to the subject's body. The clinician will apply pressure to the subject's skin at the tibialis anterior, lumbar paraspinals and upper trapezius muscles on the dominant hand side. The clinician will ask the subject "I want you to tell me the moment the sensation changes from pressure to discomfort and say "STOP". That is the reading/measurement the clinician will take. The outcome is assessing a change in pressure discomfort before the meditation and immediately after the meditation.
Time Frame
Immediately Before and immediately after intervention
Title
Neck Disability Index
Description
This is a questionnaire to measure the amount of disability the subject perceives due to their neck pain.
Time Frame
Immediately Before the intervention
Title
Oswestry Disability Index
Description
This is a questionnaire to measure the amount of disability the subject perceives due to their back pain
Time Frame
Immediately Before the intervention
Title
Pain Body Diagram
Description
This is an body image drawing. The subject colors in the area on the image of where they are experiencing pain. This outcome is assessing the location and extent of the area of pain in the body and how it changes with the intervention. The way this is assessed is by dividing the body image drawing into a grid. The body pain diagram consists of an outline of the entire body from anterior and posterior views. An overlay is created dividing the body pain diagram into 45 anatomical regions The overlay is placed over the body pain diagram, and the examiner recorded a score of 1 if pain is indicated and 0 if no pain is indicated in each of the 45 regions. Pain is considered present if any portion of the region was shaded, no matter how small.
Time Frame
Immediately Before the intervention and immediately after intervention
Title
Numeric Pain Rating Scale
Description
This is a scale assessing the subjects pain. It is a scale from 0 (no pain) to 10 (being the most severe pain). The subject will be assessed if their pain rating changed from before the intervention to after the intervention.
Time Frame
Immediately Before the intervention and immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects are from a convenience sample of patients seeking physical therapy care from a physician referral or direct-access to a privately owned physical therapy clinic English speaking
Central Sensitization Inventory > 40
Subject complains of disproportionate non mechanical unpredictable pattern of pain provocation in response to multiple non-specific aggravating/easing factors
Pain disproportionate to the nature and extent of injury or pathology
Strong association with maladaptive beliefs and pain behaviors
Diffuse, nonanatomic areas of pain and tenderness on palpation
Exclusion Criteria:
Does not meet the criteria above
Facility Information:
Facility Name
Whole Body Health Physical Therapy
City
Portland
State/Province
Oregon
ZIP/Postal Code
97212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
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