- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05498077
Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Oregon
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Portland, Oregon, United States, 97212
- Whole Body Health Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 10 minute body scan meditation
Participants will be taken through a 10 minute body scan meditation by a physical therapist
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Subject is placed through a brief body scan meditation to determine whether this intervention affects a person's pain experience
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Rating of Change
Time Frame: Immediately After intervention
|
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.
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Immediately After intervention
|
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Pain pressure Threshold
Time Frame: Immediately Before and immediately after intervention
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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.
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Immediately Before and immediately after intervention
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Neck Disability Index
Time Frame: Immediately Before the intervention
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This is a questionnaire to measure the amount of disability the subject perceives due to their neck pain.
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Immediately Before the intervention
|
|
Oswestry Disability Index
Time Frame: Immediately Before the intervention
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This is a questionnaire to measure the amount of disability the subject perceives due to their back pain
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Immediately Before the intervention
|
|
Pain Body Diagram
Time Frame: Immediately Before the intervention and immediately after intervention
|
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.
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Immediately Before the intervention and immediately after intervention
|
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Numeric Pain Rating Scale
Time Frame: Immediately Before the intervention and immediately after intervention
|
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.
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Immediately Before the intervention and immediately after intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSFMcConahay
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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