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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05498077
Other study ID # PSFMcConahay
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date December 1, 2022

Study information

Verified date August 2022
Source Therapeutic Neuroscience Research Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Body scan meditation
Subject is placed through a brief body scan meditation to determine whether this intervention affects a person's pain experience

Locations

Country Name City State
United States Whole Body Health Physical Therapy Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
Therapeutic Neuroscience Research Group Evidence in Motion, Rockhurst University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Immediately After intervention
Primary 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. Immediately Before and immediately after intervention
Primary Neck Disability Index This is a questionnaire to measure the amount of disability the subject perceives due to their neck pain. Immediately Before the intervention
Primary Oswestry Disability Index This is a questionnaire to measure the amount of disability the subject perceives due to their back pain Immediately Before the intervention
Primary 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. Immediately Before the intervention and immediately after intervention
Primary 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. Immediately Before the intervention and immediately after intervention
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